Siegal, G. et al., “Personalized Disclosure by Information-on-Demand: Attending to Patients' Needs in the Informed Consent Process,” Journal of Law, Medicine & Ethics 40, no. 2 (2012): 359-367, at 360 (“Unfortunately, the idealized process of informed consent is not often realized in practice.”); Empowering Medicare Patient Choices Act, S. 1133, 111th Cong., 1st Sess. (2009) (Wyden) (“The current standard of medical care in the United States fails to adequately ensure that patients are informed about their treatment options and the risks and benefits of those options. This leads to patients getting medical treatments they may not have wanted had they been fully informed of their treatment options and integrated into the decision making process.”).Google Scholar

Mulley, A., Trimble, C., and Elwyn, G., Patients' Preferences Matter: Stop the Silent Misdiagnosis (London: King's Fund 2012). See also J. E. Wennberg et al., “Extending the P4P Agenda, Part 1: How Medicare Can Improve Patient Decision Making and Reduce Unnecessary Care,” Health Affairs 26, no. 1 (2007): 1564-1574 (“[C]linical appropriateness would be defined by medical experts, medical necessity would be based on the patient's preference.”).Google ScholarPubMed

Id. (Mulley et al.).Google Scholar

See, e.g., Cordasco, K. M, “Obtaining Informed Consent from Patients: Brief Update Review,” in Making Health Care Safer II: An Updated Critical Analysis of the Evidence for Patient Safety Practices (Rockville, MD: AHRQ, 2013); M.A. Sekeres and T. D. Gilligan, “Informed Patient? Don't Bet On It,” New York Times (March 1, 2017).Google Scholar

Rothberg, M. B. et al., “Patients' and Cardiologists' Perceptions of the Benefits of Percutaneous Coronary Intervention for Stable Coronary Disease,” Annals Internal Medicine 153, no. 5 (2010): 307-313; M. B. Rothberg et al., Informed Decision Making for Percutaneous Coronary Intervention for Stable Coronary Disease, JAMA Internal Medicine 175, no. 7 (2015): 1199-1206.Google Scholar

Weeks, J. C. et al., “Patients' Expectations about Effects of Chemotherapy for Advanced Cancer,” New England Journal of Medicine 367, no. 17 (2012): 1616-1625.Google Scholar

Weckbach, S. et al., “A Survey on Patients' Knowledge and Expectations during Informed Consent for Spinal Surgery: Can We Improve the Shared Decision-Making Process?” Patient Safety in Surgery 10, no. 15 (2016): 1-4.CrossRefGoogle Scholar

Epstein, A. S. et al., “Discussions of Life Expectancy and Changes in Illness Understanding in Patients with Advanced Cancer,” Journal of Clinical Oncology 34, no. 20 (2016): 2398-2403.CrossRefGoogle Scholar

Kureshi, F. et al., “Variation in Patients' Perceptions of Elective Percutaneous Coronary Intervention in Stable Coronary Artery Disease: Cross Sectional Study,” BMJ 349, no. g5309 (2014): 1-13.CrossRefGoogle Scholar

See, e.g., PCORI, Funding Announcement: Assessment of Prevention, Diagnosis, and Treatment Options (May 22, 2012), available at <http://www.pcori.org/assets/PFA-Assessment-of-Prevention-Diagnosis-and-Treatment-Options.pdf> (“Every day, patients and their caregivers are faces with crucial healthcare decisions while lacking key information that they need.”) (last visited January 31, 2017); Brehaut, J. C. et al., “Informed Consent Documents Do Not Encourage Good Quality Decision Making,” Journal of Clinical Epidemiology 65, no. 7 (2012): 708-724, at 709 (“Examples of clear failures of informed consent are abundant.”); C. E. Schneider, “Void for Vagueness,” Hastings Center Report 37, no. 1 (2007): 10-11 (“A torrent of empirical evidence now suggests that informed consent does not work as intended”); Y. Shenker and A. Meisel, “Informed Consent in Clinical Care: Practical Considerations in the Effort to Achieve Ethical Goals,” JAMA 305, no. 11 (2011): 1130-1131 (observing that the “current reality of informed consent” falls short of “stated goals”); R. Gramling et al., “Determinants of Patient-Oncologist Prognostic Discordance in Advanced Cancer,” JAMA Oncology 2, no. 11 (2016): 1421-1426 (reporting that patient-oncologist discordance about survival prognosis was common); J. T. Santoso et al., “Cancer Diagnosis and Treatment: Communication Accuracy between Patients and Their Physicians,” Cancer Journal 12, no. 1 (2006): 73-76 (finding only 25% of cancer patients knew their cancer stage); K. Gülcihan Balci, “Perceived Benefits of Implantable Cardioverter Defibrillator Implantation among Heart Failure Patients and Its Relation to Quality of Life: A Cross-Sectional Study,” Cardiology & Therapy 4, no. 2 (2015): 155-165; B. J. Zikmund-Fisher et al., “The DECISIONS Study: A Nationwide Survey of US Adults Regarding Nine Common Medical Decisions,” Medical Decision Making 30, no. 5, Supp. (2010): 20S-34S; N. Couët et al., “Assessments of the Extent to Which Health Care Providers Involve Patients in Decision Making: A Systematic Review of Studies Using the OPTION Instrument,” Health Expectations 18, no. 4 (2015): 542-561; F. Fowler et al., “How Patient-Centered Are Medical Decisions?” JAMA Internal Medicine 173, no. 13 (2013): 1215-1222; C. Braddock et al., “How Doctors and Patients Discuss Routine Clinical Decisions: Informed Decision Making in the Outpatient Setting,” Journal of General Internal Medicine 12, no. 6 (1997): 339-345; M. R. Gillick, “Re-engineering Shared Decision-Making,” Journal of Medical Ethics 41, no. 9 (2015): 785-788, at n.3-4.Google Scholar

To be fair, physicians may have “technically” disclosed more information than the outcomes measures reflect. But health literacy is so low that patient's may not have comprehended or absorbed the information. National Center for Education Statistics, available at <https://nces.ed.gov/naal/health.asp> (last visited January 31, 2017). (last visited January 31, 2017).' href=https://scholar.google.com/scholar?q=To+be+fair,+physicians+may+have+“technically”+disclosed+more+information+than+the+outcomes+measures+reflect.+But+health+literacy+is+so+low+that+patient's+may+not+have+comprehended+or+absorbed+the+information.+National+Center+for+Education+Statistics,+available+at++(last+visited+January+31,+2017).>Google Scholar

Alston, C. et al., Shared Decision-Making Strategies for Best Care: Patient Decision Aids, Institute of Medicine, September 2014, available at <http://nam.edu/perspectives-2014-shared-decision-making-strategies-for-best-care-patient-decision-aids/> (“[P]atient's preferences and values are left out….”) (last visited January 31, 2017).Google Scholar

See infra Section V(A). The term was first used over 30 years ago. Wall, E. M., “Development of a Decision Aid for Women Choosing a Method of Birth Control,” Journal of Family Practice 21, no. 5 (1985): 351-355.Google Scholar

See infra Section V(B).Google Scholar

See infra Section VI.C.Google Scholar

See infra Section VI(C).Google Scholar

See infra Section VI.D.Google Scholar

See generally Starr, P., The Social Transformation of American Medicine: The Rise of a Sovereign Profession and the Making of a Vast Industry (New York: Basic Books, 1982): at 79-144; R. R. Faden and T. L. Beauchamp, A History and Theory of Informed Consent (New York: Oxford University Press, 1986): 76-100, 114-124; D. J. Rothman, Strangers at the Bedside: A History of How Law and Bioethics Transformed Medical Decision Making (New York: Basic Books, 1991); J. Katz, The Silent World of Doctor and Patient (Baltimore: Johns Hopkins University Press, 2002).Google Scholar

American Medical Association, Code of Medical Ethics (Chicago, AMA Press, 1847).Google Scholar

Jr, T. E. C.., “Oliver Wendell Holmes on Telling the Patient the Whole Truth,” Pediatrics 69, no. 5 (1982): 528-529.Google Scholar

Schloendorff v. Society of New York Hospital, 105 N.E. 92 (N.Y. 1914).Google Scholar

Id., at 93.Google Scholar

See, e.g., Mohr v. Williams, 104 N.W. 12, 13 (Minn. 1905); Rolater v. Strain, 137 P. 96 (Okla. 1913); Schloendorff v. Soc'y N.Y. Hosp., 105 N.E. 92, 93 (N.Y. 1914).Google Scholar

Pope, T. M., “Clinicians May Not Administer Life-Sustaining Treatment without Consent: Civil, Criminal, and Disciplinary Sanctions,” Journal of Health & Biomedical Law 9, no. 2 (2013): 213-296; T. M. Pope, “Legal Briefing: New Penalties for Disregarding Advance Directives and Do-Not-Resuscitate Orders,” Journal of Clinical Ethics 28, no. 1 (2017): 74-81. Traditional informed consent law has its origins in the tort of medical battery.Google Scholar

See Pope, T. M., “Voluntarily Stopping Eating and Drinking: A Legal Treatment Option at the End of Life,” Widener Law Review 17, no. 2 (2011): 363, 402-407 (analyzing battery claims for unwanted treatment); DiGeronimo v. Fuchs, 927 N.Y.S.2d 904, 908 (N.Y. Sup. Ct. 2011), affirmed, in part, 2011-08304, 2012 LEXIS 8613 (N.Y. App. Div. Dec. 19, 2012) (noting that “[a]dministering a blood transfusion without informed consent is best characterized as a battery”) (citing Salandy v. Bryk, 864 N.Y.S.2d 46 (N.Y. App. Div. 2008)).Google Scholar

Restatement (Second) Torts § 13 (1965).Google Scholar

Restatement (Second) Torts § 8A (1965).Google Scholar

Scott v. Bradford, 606 P.2d 554, 557 (Okla. 1979) (stating unauthorized medical treatment constitutes battery); Chambers v. Nottebaum, 96 So. 2d 716, 718 (Fla. Dist. Ct. App. 1957) (characterizing medical operation without patient consent as battery).Google Scholar

See, e.g., Scholendorff v. Soc'y of N.Y. Hosp., 105 N.E. 92 (N.Y. 1914) (addressing patient consented to biopsy, not surgery); Pizzalotto v. Wilson, 437 So. 2d 859 (La. 1983) (addressing patient consented to exploratory surgery, not removal of reproductive organs); Perna v. Pirozzi, 457 A.2d 431 (N.J. 1983) (consenting to operation with only one specific doctor); Paulsen v. Gunderson, 260 N.W. 448 (Wis. 1935) (analyzing patient consent to a “simple” ear operation, and instead underwent a “radical” ear operation); Franklyn v. Peabody, 228 N.W. 681 (Mich. 1930) (operating on thumb without consent); Gill v. Selling, 267 P. 812 (Ore. 1928) (performing spinal puncture on wrong patient), overruled by Fredeen v. Stride, 525 P.2d 166 (Ore. 1974); Hively v. Higgs, 253 P. 363 (Ore. 1927) (noting removal of tonsils during septum operation); Hershey v. Peake, 223 P. 1113 (Kan. 1924) (concerning wrong tooth); Throne v. Wandell, 186 N.W. 146 (Wis. 1922) (addressing patient consent to examination, not extraction of six teeth); Moos v. U.S., 225 F.2d 705 (8th Cir. 1955) (operating on wrong leg); Kaplan v. Mamelak, 75 Cal. Rptr. 3d 861 (Cal. Ct. App. 2008) (operating on wrong spinal disk); Perry v. Shaw, 106 Cal. Rptr. 2d 70, 72 (Cal. Ct. App. 2001) (concerning patient consent to removal of excess skin, not breast augmentation); Ashcraft v. King, 278 Cal. Rptr. 900 (Cal. Ct. App. 1991) (analyzing patient imposed condition on consent); Bommareddy v. Superior Ct., 272 Cal. Rptr. 246 (Cal. Ct. App. 1990) (concerning patient agreed to tear duct surgery, not cataract extraction); Lane v. U.S., 225 F. Supp 850 (E.D. Va. 1964) (addressing surgery on wrong knee); McCoid, A. H., “A Reappraisal of Liability for Unauthorized Medical Treatment,” Minnesota Law Review 41, no. 4 (1957): 381-434.Google Scholar

In re Dinnerstein, 380 N.E.2d 134, 135-36 (Mass. App. 1978); see also Meisel, Cerminara & Pope § 6.02 (collecting cases); see Markart v. Zeimer, 227 P. 683 (Cal. App. 1924) (concerning removal of testicle).Google Scholar

D. B. Dobbs, The Law of Torts § 33, at 81 (St. Paul: West Academic, 2000) (“It is enough that the defendant intends bodily contact that is ‘offensive,’ which is to say a bodily contact that does not appear acceptable to the plaintiff.”); Moore, N. J., “Intent and Consent in the Tort of Battery: Confusion and Controversy,” American University Law Review 61, no. 6 (2012): 1585-1656, at 1595; Horace, “Ars Poetica,” line 467 (Transl. A.S. Kline 2005) (“[W]ho saves one, against his will, murders him”).Google Scholar

See, e.g., Mohr, 104 N.W. at 15 (requiring consent in non-emergency situations), overruled in part by Genzel v. Halvorson, 80 N.W.2d 854 (Minn. 1957); Restatement (Second) of Torts §§ 892, illus. 1, at 435 (1965); see also Montgomery v. Bazaz-Seghal, 742 A.2d 1125, 1130 (Pa. Super. Ct. 1999), aff ’d, 798 A.2d 742 (Pa. 2002) (discussing urologist implanted penile prosthesis without patient's knowledge or consent); Taylor v. Johnston, 985 P.2d 460 (Alaska 1999) (obtaining patient consent by fraud); Millard v. Nagle, 587 A.2d 10 (Pa. 1991) (seeking damages for unauthorized surgery despite physician intention); Perna v. Pirozzi, 457 A.2d 431, 439 (N.J. 1983) (“A nonconsensual operation remains a battery even if performed skillfully and to the benefit of the patient.”); Pugsley v. Privette, 263 S.E.2d 69 (Va. 1980) (holding that unconsented medical treatment constitutes a battery, even though such medical treatment may be beneficial to the plaintiff); Rogers v. Lumbersmens Mut. Casualty Co., 119 So. 2d 649 (La. 1960); Genzel v. Halvorson, 80 N.W.2d 854 (Minn. 1957) (performing surgery without consent is battery); Kennedy v. Parrott, 90 S.E.2d 754 (N.C. 1956) (analyzing causation between doctor's action and patient's harms in battery action); Franklyn v. Peabody, 228 N.W. 681 (Mich. 1930) (operating on patient's right thigh without consent to obtain tissue for a procedure on patient's thumb constitutes battery); Perry v. Hodgsen, 148 S.E. 659 (Ga. 1929) (noting patient consent required unless emergency); Barrette v. Lopez, 725 N.E.2d 314 (Ohio Ct. App. 1999) (distinguishing medical negligence from battery); Rodriguez v. Pino, 634 So. 2d 681 (Fla. Dist. Ct. App. 1994) (holding physician not liable for patient's refusal to consent); Lounsbury v. Capel, 836 P.2d 188, 199 (Utah Ct. App. 1992) (remanding for damages even though surgery somewhat beneficial); Estate of Leach v. Shapiro, 469 N.E.2d 1047, 1051 (Ohio Ct. App. 1984) (“A physician who treats a patient without consent commits a battery, even though the procedure is harmless or beneficial.”); Mims v. Boland, 138 S.E.2d 902 (Ga. Ct. App. 1964) (recognizing physician treatment without consent is guilty of technical battery); McCandless v. State, 162 N.Y.S.2d 570 (N.Y. App. Div. 1957) (affirming $2,000 in damages even though procedure less harmful and improved patient's mental health); Church v. Adler, 113 N.E.2d 327 (Ill. App. Ct. 1953) (reviewing cause of medical negligence); Mulloy v. Hop Sang, 1 W.W.R. 714 (Can. A.R. 1935) (holding that even a successful operation, contrary to patient instructions, was still a battery).Google Scholar

Dobbs, supra note 31, at 80 (“Even beneficial touchings such as medical procedures may warrant damages if they are batteries.”). The Second Restatement of Torts provides an applicable example: A has a wart on his neck. His physician, B, advises him to submit to an operation for its removal. A refuses to do so. Later A consents to another operation…B removes the wart. The removal in no way affects A's health, and is in fact beneficial. A has suffered bodily harm. Restatement (Second) of Torts § 15, illus. 1 (1965).Google Scholar

See Meisel, Cerminara & Pope § 2-24 n.104; Chambers v. Nottebaum, 96 So. 2d 716 (Fla. Dist. Ct. App. 1957) (concerning lack of consent for spinal anesthesia); Corn v. French, 289 P.2d 173 (Nev. 1955) (alleging mastectomy without consent); Woodson v. Huey, 261 P.2d 199 (Okla. 1953) (affirming need for consent to give anesthesia); Tabor v. Scobee, 254 S.W.2d 474 (Ky. Ct. App. 1952) (addressing removal of fallopian tubes during operation for appendicitis); Williams, 104 N.W. at 15-16 (discussing operation on left ear but consent obtained only for right ear), overruled in part by Genzel v. Halvorson, 80 N.W.2d 854 (Minn. 1957); Rolater v. Strain, 137 P. 96 (Okla. 1913) (addressing removal of sesamoid bone without consent); Hively v. Higgs, 253 P. 363 (Or. 1927) (addressing removal of tonsils with only consent for septum surgery); Wells v. Van Nort, 125 N.E. 910 (Ohio 1919) (analyzing physician decision to remove fallopian tubes); Schloendorff v. Soc'y N.Y. Hosp., 105 N.E. 92 (N.Y. 1914) (addressing unauthorized surgery), abrogated by Bing v. Thunig, 143 N.E.2d 3 (1957); Sekerez v. Rush Univ. Med. Ctr., 954 N.E.2d 383 (Ill. App. Ct. 2011) (reversing directed verdict for defendants who administered Lovenox to terminally ill cancer patient against his stated and documented wishes); Gragg v. Calandra, 696 N.E.2d 1282, 1290 (Ill. App. Ct. 1998) (“Although a defendant may reasonably believe that his objective is legitimate, it does not provide him with carte blanche to pursue that objective by outrageous means.”); Kaplan v. Blank, 419 S.E.2d 127 (Ga. Ct. App. 1992) (claiming lack of written consent for tubal ligation); Markart v. Zeimer, 227 P. 683 (Cal. Ct. App. 1924) (reviewing negligence in hernia surgery).Google Scholar

Medical associations and policymakers are focused on identifying commonly performed tests and procedures that offer little or no clinical benefit. This is a great start on reducing overuse and improving healthcare quality. But it is not enough. Benefit is a function not only of medical science but also of patient preferences. Schwartz, A. L. et al., “Measuring Lower-Value Care in Medicare,” JAMA Internal Medicine 174, no. 7 (2014): 1067-1076.Google Scholar

Moore at 1611, 1621; Curtis v. Jaskey, 326 Ill. App. 3d 90, 94 (2001) (noting that it is unnecessary for plaintiff to prove defendant physician had hostile intent); McNeil v. Brewer, 304 Ill. App. 3d 1050, 1154-55 (1999).Google Scholar

Dobbs, supra note 31, at 342 (“Even beneficial…medical procedures warrant damages if they are batteries.”). “A person is entitled to refuse well-intentioned medical treatment.” Id., at § 29, at 54; see Urlaub v. Select Specialty Hosp. Memphis, No. W2010-00732-COA-R3-CV, 2011 WL 255281 1, 6 (Tenn App. Jan. 20, 2011) (administering dialysis contrary to instructions could constitute a battery by not following the standard of care necessitated by informed consent); Mink v. Univ. Chicago, 460 F. Supp. 713, 717 (N.D. Ill. 1978); Beane v. Perley, 109 A.2d 848, 850 (N.H. 1954) (recognizing the difficulty in providing medical expert testimony as required in malpractice suits). But see Pleasure v. Louisiana Organ Procurement Ass'n, 83 So. 3d 174 (La. App. 2011) (affirming judgment that continuing life-support and removing organs without consent sounded in medical malpractice), rev. denied, 85 So. 3d 1248 (La. 2012). While the conferral of “benefit” by the unwanted treatment does not affect the cause of action, it is considered in determining the amount of the award. Harper, F. V. et al., Harper, James and Gray on Torts, 3d ed. (New York: Aspen, 2006): at 348. Nevertheless, it is problematic to characterize as a “benefit” a state of life the person living that life finds intolerable.Google Scholar

As litigation costs decrease, clinician compliance rates should rise. Hylton, K. N., “Litigation Cost Allocation Rules and Compliance with the Negligence Standard,” Journal of Legal Studies 22, no. 2 (1993): 457-476, at 459.Google Scholar

See Dobbs, supra note 31, at § 42, at 79 (“When the trespassory tort causes no physical harm, the traditional tort rule is that the plaintiff can nevertheless recover substantial as distinct from nominal damages…The invasion of the plaintiff's rights is regarded as harm in itself…”); id., § 100, at 234 n.17 (“The difference is that a battery is actionable without proof of bodily harm or economic loss; the offensive touching is harm in itself.”); id., § 28, at 54 (“Battery today vindicates the plaintiff's rights of autonomy and self-determination, her right to decide for herself how her body will be treated by others”); B v. NHS Hosp. Trust [2002] EWHC 429 (awarding £100 nominal damages).Google Scholar

See, e.g., Whitley-Woodford v. Jones, 600 A.2d 946, 947-48 (N.J. Super. Ct. App. Div. 1992) (noting that an operation undertaken without consent, even if perfectly performed with good medical results, may entitle the plaintiff to at least nominal damages and even punitive damages).Google Scholar

This has been confirmed in battery cases involving life-sustaining treatment. See generally Shandell, R. E. and Smith, P., The Preparation and Trial of Medical Malpractice Cases § 1.06[6] (New York: Law Journal Press, 2006); Gragg v. Calandra, 696 N.E.2d 1282, 1286 (Ill. App. 1998); Russell v. Murphy, 86 S.W.3d 745, 748-50 (Tex. App. 2002) (holding medical standards irrelevant where anesthesiologist administered sedative despite patient's specific request for local anesthetic); Jones v. Ruston La. Hosp. Co., 71 So. 3d 1154 (La. App. 2011) (holding Medical Malpractice Act and review by “medical review panel” inapplicable where clinician resuscitated Agnes Liles despite “knowledge of the DNR order”); Abeyta v. HCA Health Servs. of Tenn., No. M2011–02254–COA–R3–CV, 2012 WL 5266321 (Tenn. App. Oct. 24, 2012) (having not filed a certificate of good faith did not amount to malpractice, but ordinary negligence, not requiring expert testimony). But cf. Shuler v. McGrew, No. 12–2003–STA–dkv, 2012 WL 3260685 1, 6 (W.D. Tenn. Aug. 8, 2012) (holding that administration of Heparin over patient's objections was not battery because it was a “component part of the treatment process” and providers had patient's consent to be treated at the hospital).Google Scholar

See Harper et al., supra note 37, at § 3.10, at 351.Google Scholar

See, e.g., Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972); Wilkinson v. Vesey, 295 A.2d 676 (R.I. 1972); Cobbs v. Grant, 8 Cal.3d 229 (1972); Holt v. Nelson, 523 P. 2d 211 (Wash. 1974); Riedinger v. Colburn, 361 F. Supp. 1073 (D. Idaho 1973); Scaria v. St. Paul Fire & Marine Ins. Co., 227 N.W.2d 647 (Wis. 1975); Sard v. Hardy, 379 A.2d 1014, 1021 (Md. 1977). A handful of cases had earlier articulated a theory of informed consent. See, e.g., Salgo v. Leland Stanford, Jr., University Board of Trustees, 154 Cal. App. 2d 560, 317 P. 2d 170 (Dist. Ct. of App. 1957); Natanson v. Kline, 186 Kan. 393, 402, 350 P.2d 1093, 1100 (1960). But the doctrine was not more fully articulated and more widely adopted until the 1970s. Cf. Krause, J. H., “Reconceptualizing Informed Consent in an Era of Cost Containment,” Iowa Law Review 85, no. 1 (1999): 261-386, at 270-271.Google Scholar

King, J. Staples and Moulton, B., “Rethinking Informed Consent: The Case for Shared Medical Decision Making,” American Journal of Law & Medicine 32, no. 4 (2006): 429-501.CrossRefGoogle Scholar

In some states, there is no common law duty of informed consent. It exists solely as a matter of statute and is often more narrowly circumscribed. Alicea (Ga. 2016); Pruette v. Ungarino, No. A131833 (Ga. App. 27 Mar. 2014); Pagani v. Weiss, No. J-A05017-14 (Penn. Super. Ct. 27 Mar. 2014). See also Sawicki, N. N., “Modernizing Informed Consent: Expanding the Boundaries of Materiality,” University of Illinois Law Review 2016, no. 3 (2016): 821-872 (collecting citations from Iowa, Louisiana, and Pennsylvania).Google Scholar

The most salient enforcement of informed consent obligations occurs through medical malpractice litigation. But there are other mechanisms to enforce clinicians' obligation to obtain informed consent. The state medical boards are particularly frequent enforcers of informed consent duties. Miller, T., “Informed Consent: A Medical Board Analysis,” Journal of Medical Regulation 96, no. 3 (2010): 16-22. For example, the Maine Board of Licensure in Medicine recently reported that approximately one-third of the cases it investigates each year includes allegations of failure to obtain adequate and meaningful informed consent. D. Nyberg, “Obtaining Meaningful Informed Consent: Guidelines from the Maine Board of Licensure in Medicine,” Journal of Medical Regulation 99, no. 3 (2013): 18-21. Similarly, a recent report by the Wisconsin Medical Examining Board reviewed eleven years of final decisions and orders by the board. This report shows that informed consent violations were one of the most common reasons for discipline. Furthermore, Maine and Wisconsin are not alone. Other state medical boards have also been regularly enforcing informed consent duties. In re George Der Mesropian, No. 13-418, 2013 WL 6869796 (N.Y. Board of Professional Medical Conduct 16 Dec. 2013); In re Richard Godt, No. 13-181, 2013 WL 3288372 (N.Y. Board of Professional Medical Conduct 14 June 2013); J.V. v. D.G.C., 2013 CanLII 40382 (ON HPARB); Fitness to Practice Medicine: Robert Theodore Henri Kees Trossel, General Medical Council (29 Sept. 2010). While rare, breaches of informed consent have sometimes resulted in criminal liability. T.M. Pope and M. Hexum, “Legal Briefing: Informed Consent in the Clinical Context,” Journal of Clinical Ethics 25, no. 2 (2014): 152-174.Google Scholar

See King and Moulton, supra note 44. This article includes an appendix of state informed consent laws. Similar appendices can be found in other recent articles. Studdert, D. M. et al., “Geographic Variation in Informed Consent Law: Two Standards for Disclosure of Treatment Risks,” Journal of Empirical Legal Studies 4, no. 1 (2007): 103-124; W.G. Cobb, “Defending the Informed Consent Case,” Defense Counsel Journal 72, no. 4 (2005): 330-346. Some states, like Minnesota, are identified as using a “modified” or “hybrid” approach.Google Scholar

Lewis, M. H., Gohagan, J. K., and Merenstein, D. J, “The Locality Rule and the Physician's Dilemma: Local Medical Practices versus the National Standard of Care,” JAMA 297, no. 23 (2007): 2633-2637.Google Scholar

See, e.g., Wheeldon v. Madison, 374 N.W.2d 367, 374 (S.D. 1985); Largey v. Rothman, 540 A.2d 504, 508 (N.J. 1988); Cross v. Trapp, 294 S.E.2d 446, 455 (W. Va. 1982). Cf. Montgomery v. Lanarkshire Health Board, [2015] UKSC 11 ¶ 46 (“The doctor cannot form an objective, “medical” view of these matters, and is therefore not in a position to take the “right” decision as a matter of clinical judgment.”); id. ¶ 115 (“[A] responsible body of medical opinion, becomes quite inapposite. A patient is entitled to take into account her own values, her own assessment of the comparative merits.”). Recognizing the subjectivity of benefit, many encourage clinicians to do as much as possible “for” the patient and as little as possible “to” the patient.Google Scholar

See, e.g., Jandre v. Physicians Ins. Co., 340 Wis.2d 31, 813 N.W.2d 627 (2012). See generally Derse, A. R., “Flying Too Close to the Sun: Lessons Learned from the Judicial Expansion of the Objective Patient Standard for Informed Consent in Wisconsin,” Journal of Law, Medicine & Ethics 45, no. 1 (2017): 51-59.CrossRefGoogle Scholar

Wis. A.B. 139 (2013), enacted as 2013 Wis. Acts 111, amending Wis. Stat. § 448.30.Google Scholar

Id.Google Scholar

Wisconsin Department of Safety and Professional Services, Analysis of Proposed Order of the Medical Examining Board (May 21, 2014), available at <http://dsps.wi.gov/Documents/Board%20Services/Agenda%20Materials/Medical/2014/20140521%20MED%20Open%20Session.pdf> (last visited January 31, 2017). See also A. Szczygiel, “Beyond Informed Consent,” 21 Ohio Northern University Law Review 21, no. 1 (1994): 171-262; J. L. Dolgin, “The Legal Development of the Informed Consent Doctrine: Past and Present,” Cambridge Quarterly Healthcare Ethics 19, no. 1 (2010): 97-109, at 101 (noting how other state legislatures replaced court adopted reasonable patient standard with the professional standard, and noting how that standard is preferred by physicians).+(last+visited+January+31,+2017).+See+also+A.+Szczygiel,+“Beyond+Informed+Consent,”+21+Ohio+Northern+University+Law+Review+21,+no.+1+(1994):+171-262;+J.+L.+Dolgin,+“The+Legal+Development+of+the+Informed+Consent+Doctrine:+Past+and+Present,”+Cambridge+Quarterly+Healthcare+Ethics+19,+no.+1+(2010):+97-109,+at+101+(noting+how+other+state+legislatures+replaced+court+adopted+reasonable+patient+standard+with+the+professional+standard,+and+noting+how+that+standard+is+preferred+by+physicians).>Google Scholar

The plaintiffs may also have to contend with the physicians' argument that one or more “exceptions” applies.Google Scholar

For both an overview and in-depth analysis of informed consent law, see Rozovsky, F. A., Consent to Treatment: A Practical Guide, 4th ed. (New York: Wolters-Kluwer, 2009); S. E. Pegalis, American Law of Medical Malpractice, 3rd ed. (St. Paul: Thomson/West, 2009): at chap. 4.Google Scholar

On some measures, the impact was dramatic. In 1961, 90% of physicians refrained from telling patients about a cancer diagnosis. By 1979, that dropped to just 2%. See Dolgin, supra note 53, at 100 (citing Oken, D., “What to Tell Cancer Patients: A Study of Medical Attitudes,” JAMA 175, no. 13 (1961): 1120-1128; D. H. Novack et al., “Changes in Physicians' Attitudes toward Telling the Cancer Patient,” JAMA 241, no. 9 (1979): 897-900.Google Scholar

See supra notes 4 to 12. Indeed, some of the limitations were recognized early on. See President's Commission for the Study of Ethical Problems in Medicine, Making Health Care Decisions A Report on the Ethical and Legal Implications of Informed Consent in the Patient-Practitioner Relationship Volume One: Report (October 1982).Google Scholar

McCarthy, D. et al., “What Did the Doctor Say? Health Literacy and the Recall of Medical Instructions,” Medical Care 50, no. 4 (2012): 277-282; F. J. Fowler Jr. et al., “Improving and Involving Patients to Improve the Quality of Medical Decisions,” Health Affairs 30, no. 4 (2011): 699-706; M. Brezis et al., “Quality of Informed Consent for Invasive Procedures,” International Journal for Quality Health Care 20, no. 5 (2008): 352-357; D. B. White et al., “Toward Shared Decision Making at the End of Life in Intensive Care Units Opportunities for Improvement,” Archives of Internal Medicine 167, no. 5 (2007): 461-467; see Staples King and Moulton, supra note 44; M. M. Bottrell et al, “Hospital Informed Consent for Procedure Forms: Facilitating Quality Patient-Physician Interaction,” Archives of Surgery 135, no. 1 (2000): 26-33; C. H. Braddock et al., “Informed Decision Making in Outpatient Practice: Time to Get Back to Basics,” JAMA 282, no. 24 (1999) (finding less than 10% of decisions met minimum standards for informed consent): 2313-2320; K. E. Covinsky et al., “Communication and Decision Making in Seriously Ill Patients: Findings of the SUPPORT Project: The Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatment,” Journal of American Geriatrics Society 48, no. 5 Supp. (2000): S187-S193 (only 41% of Medicare patients believe their treatment reflected their preferences).CrossRefGoogle Scholar

Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972) (“Any definition of scope in terms purely of a professional standard is at odds with the patient's prerogative to decide on projected therapy himself. That prerogative, we have said, is at the very foundation of the duty to disclose, and both the patient's right to know and the physician's correlative obligation to tell him are diluted to the extent that its compass is dictated by the medical profession.”).Google Scholar

See, e.g., D. Merenstein, “A Piece of My Mind: Winners and Losers,” JAMA 291, no. 1 (2004): 15-16; D. Merenstein, “PSA Screening - I Finally Won!” JAMA Intern Medicine 175, no. 1 (2015): 16-17; see M. Hall, “The Defensive Effect of Medical Practice Policies in Malpractice Litigation,” Law and Contemporary Problems 54, no. 2 (1991): 119-145, at 129-30 (noting that medical practice is guided by instinct and localized habit).Google Scholar

See, e.g., Faden and Beauchamp, supra note 18, at 305-306 (arguing that a subjective standard is more in line with the principles underlying informed consent); Tenenbaum, E. M., “Revitalizing Informed Consent and Protecting Patient Autonomy: An Appeal to Abandon Objective Causation, Oklahoma Law Review 64, no. 4 (2011): 697-758, at 717-719 (arguing that an objective standard is “unfaithful” to the underlying autonomy-based ideals of informed consent).Google Scholar

Montgomery v. Lanarkshire Health Board, [2015] UKSC 11 ¶ 46 (“The relative importance attached by patients to quality as against length of life, or to physical appearance or bodily integrity as against the relief of pain, will vary from one patient to another. Countless other examples could be given of the ways in which the views or circumstances of an individual patient may affect their attitude towards a proposed form of treatment and the reasonable alternatives.”).Google Scholar

See Tenenbaum, supra note 61. On the other hand, courts have recognized that a subjective standard may be difficult one for physicians to comply. See, e.g., Canterbury, 464 F.2d at 790-91.Google Scholar

Scott v. Bradford, 606 P.2d 554, 559 (Okla. 1979). While other states have considered and rejected Oklahoma's approach, Oklahoma continues to adhere to a subjective standard. Opala, M. P. and Sanbar, S. S., “Informed Consent and Informed Refusal in Oklahoma,” Oklahoma State Medical Association Journal 102, no. 3 (2009): 86-91.Google Scholar

Only four states – New Hampshire, Rhode Island, Oklahoma, and Oregon – have case law or statutes that reject the objective “reasonable patient” standard. See Tenenbaum, supra note 61; Pickering Cause of Action.Google Scholar

BMJ Clinical Evidence, “Efficacy Categorisations,” see <http://www.clinicalevidence.bmj.com/x/set/static/cms/efficacy-categorisations.html> (last visited March 23, 2017) (finding that only 11% of treatment is “clearly” beneficial).+(last+visited+March+23,+2017)+(finding+that+only+11%+of+treatment+is+“clearly”+beneficial).>Google Scholar

Canadian Task Force (2014).Google Scholar

42 U.S.C. § 299b-36(b)(2) (defining “preference sensitive care” as “medical care for which the clinical evidence does not clearly support one treatment option such that the appropriate course of treatment depends on the values of the patient or the preferences of the patient, caregivers or authorized representatives regarding the benefits, harms and scientific evidence for each treatment option.”).Google Scholar

42 U.S.C. § 299b-36(b)(2); Patient-Centered Outcomes Research Institute, PCORI PFA Cycle I Awardees (December 21, 2012), at 2, available at <http://www.pcori.org/assets/PFA-Awards-Cycle-1-2012.pdf> (last visited February 1, 2016) (Decision Support for Parents Receiving Genetic Information about Child's Rare Disease).+(last+visited+February+1,+2016)+(Decision+Support+for+Parents+Receiving+Genetic+Information+about+Child's+Rare+Disease).>Google Scholar

See Fowler et al., supra note 10, at 700. See also Khullar, D., “Helping Patients Make the Right Decisions,” New York Times, September 15, 2016 (“Should you choose six months of life with chemotherapy and intractable nausea, or three months at home chemo-free?”).Google Scholar

See Tenenbaum, supra note 61.Google Scholar

Scott v. Bradford, 606 P.2d 554 (Okla. 1979).Google Scholar

Jones, C. J., “Autonomy and Informed Consent in Medical Decisionmaking: Toward a New Self-Fulfilling Prophecy,” Washington and Lee Law Review 47, no. 2 (1990): 379-430. But cf. Montgomery v. Lanarkshire Health Board, [2015] UKSC 11 ¶ 90 (“[T]he doctor's advisory role involves dialogue, the aim of which is to ensure that the patient understands the seriousness of her condition, and the anticipated benefits and risks of the proposed treatment and any reasonable alternatives, so that she is then in a position to make an informed decision. This role will only be performed effectively if the information provided is comprehensible. The doctor's duty is not therefore fulfilled by bombarding the patient with technical information which she cannot reasonably be expected to grasp…”) (emphasis added).Google Scholar

Siegal et al., supra note 1, at 359; Alston, supra note 12, at 3 (describing informed consent as a “one-way information delivery scheme”).Google Scholar

Other commentators have analogized the practice of informed consent to “banking” in which the physician “deposits” information into the patient's “bank.” Volandes, A. E. et al., “The New Tools: What 21st Century Education Can Teach Us,” Healthcare 1, no. 3-4 (2014): 79-81, at 79. The practice might also be analogized to giving someone the keys to a new experimental vehicle without explaining how to drive it.Google Scholar

See Restatement of Contracts 2d § 63. See also Adams v. Lindsell, 106 Eng. Rep. 250 (K.B. 1818); Cal. Civ. Code § 1583.Google Scholar

Cobbs v. Grant (Cal. 1972).Google Scholar

See supra notes 2 to 12. See also Wennberg, supra note 2, at 1565 (“Policymakers have assumed that physician's decisions reflect both medical need and patient demand. However, the remarkable degree of variation in the utilization rates of discretionary surgery raises questions about these assumptions.”); id., at 1570 (describing the current realm as “delegated decision making”); Kennedy, A. D. et al., “Effects of Decision Aids for Menorrhagia on Treatment Choices, Health Outcomes, and Costs: A Randomized Controlled Trial,” JAMA 288, no. 21 (2002): 2701-2708. Substantial evidence shows that the treatment patients get depends more on the physician than on the patient's preferences. See <http://www.dart-mouthatlas.org> (last visited February 1, 2017).Google Scholar

But see Sawicki, supra note 45.Google Scholar

Hawker, G.A. et al., “Determining the Need for Hip and Knee Arthroplasty: The Role of Clinical Severity and Patient Preferences,” Medical Care 39, no. 3 (2001): 206-216.CrossRefGoogle Scholar

Moreover, most states hold there is not even a duty to disclose non-medical information such as costs, even in material risk jurisdictions. See Sawicki, supra note 45.Google Scholar

CDC, State Laws Relating to Breast Cancer (Atlanta: CDC, 2000).Google Scholar

See, e.g., Cal. Health & Safety Code § 109275.Google Scholar

See, e.g., Ga. Code. Ann. § 31-9-6.1; Ark. Code Ann. § 17-95-108; Cal. Health & Safety Code § 1690.Google Scholar

Chinn, G. M. et al., “Physicians' Preferences for Hospice if They Were Terminally Ill and the Timing of Hospice Discussions with their Patients,” JAMA Internal Medicine 174, no. 3 (2014): 466-468; A.B. Astrow and B. Popp, “The Palliative Care Information Act in Real Life,” New England Journal of Medicine 264, no. 20 (2011): 1885-1887.Google Scholar

Panagopolou, E. et al., “Concealment of Information in Clinical Practice: Is Lying Less Stressful Than Telling the Truth?” Journal of Clinical Oncology 26, no. 7 (2008): 1175-1177; I. Torjesen, “1 in 4 GPs Remains Reluctant to Initiate End-of-Life Discussion with Patients,” BMJ 348, no. g3195 (2014): 1-2; D. K. Heyland et al., “Failure to Engage Hospitalized Elderly Patients and Their Families in Advance Care Planning,” JAMA Internal Medicine 173, no. 9 (2013): 778-787; W. G. Anderson, S. Kools, and A. Lyndon, “Dancing around death: Hospitalist-Patient Communication about Serious Illness,” Qualitative Health Research 23, no. 1 (2013): 3-13; Royal College of Physicians and Marie Curie Palliative Care Institute Liverpool, National Care of the Dying Audit for Hospitals, England: National Report (2014).CrossRefGoogle Scholar

Zhang, B. et al., “Health Care Costs in the Last Week of Life: Associations with End of Life Conversations,” Archives of Internal Medicine 169, no. 5 (2009): 480-488.Google Scholar

Mack, J. W. et al., “End-of-Life Care Discussions among Patients with Advanced Cancer: A Cohort Study,” Annals of Internal Medicine 156, no. 3 (2012): 204-210; S. M. Dunlay et al., “A Survey of Clinician Attitudes and Self-Reported Practices Regarding End-of-life Care in Heart Failure,” Palliative Medicine 29, no. 3 (2015): 260-267 (reporting that only 12% of clinicians had end-of-life discussions as advocated by the American Heart Association).Google Scholar

Wright, A. A., “Associations between End-of-Life Discussions, Patient Mental Health, Medical Care near Death, and Care-giver Bereavement Adjustment,” JAMA 300, no. 14 (2008): 1665-1673.CrossRefGoogle Scholar

Moreover, the quality of these discussions is questionable. See, e.g., White, Douglas B. et al., “Prevalence of and Factors Related to Discordance About Prognosis Between Physicians and Surrogate Decision Makers of Critically Ill Patients,” JAMA 315, no. 19 (2016): 2086-2094 (finding common discordant expectations about prognosis between patients' physicians and surrogate decision makers).Google Scholar

Cal. A.B. 2747 (2009), codified at Cal. Health & Safety Code § 442.5.Google Scholar

Vt. H.B. 435 (2009) (Patient Bill of Rights for Palliative Care and Pain Management), enacted as Vt. Laws No. 25, codified at Vt. Stat. tit. 18, § 1871.Google Scholar

N.Y. A.B. 7617 (2010), enacted as 2010 Sess. Laws of N.Y. Ch. 331, codified at N.Y. Pub. Health Law § 2997-c; amended in 2012 by N.Y. S.B. 7596 (2012), enacted as 2012 Sess. Laws of N.Y. Ch. 256.Google Scholar

Mass. S.B. 2400 (2012), enacted as 2012 Mass. Legis. Serv. Ch. 224 § 103 (Massachusetts Act Improving the Quality of Health Care and Reducing Costs through Increased Transparency, Efficiency, and Innovation”), codified at Mass. Stat. 111 § 227.Google Scholar

Ariz. S.B. 1304 (2013). Other states considered similar bills. Md. S.B. 546 (2009); Md. H.B. 30 (2009); Ariz. S.B. 1304 (2009). Similar information and counseling was earlier required in the 1996 Michigan Dignified Death Act. Mich. Comp. Laws § 333.5651.Google Scholar

N.Y. Pub. Health Law § 2997-c(2)(a); Mass. Stat. 111 § 227(c).Google Scholar

N.Y. Pub. Health Law § 2997-c(2)(b); Mass. Stat. 111 § 227(c).Google Scholar

N.Y. Pub. Health Law § 2997-c(3).Google Scholar

N.Y. Pub. Health Law § 2997-c(3); Mass. Stat. 111 § 227(c).Google Scholar

I called for this nearly 20 years ago. Pope, T. M., “The Mal-adaptation of Miranda to Advance Directives: A Critique of the Implementation of the Patient Self-Determination Act,” Health Matrix 9, no. 1 (1999): 139-202, at 196-200.Google Scholar

N.Y. Pub. Health Law § 2997-d.Google Scholar

Md. H.B. 581 (2013), enacted at 2013 Maryland Laws Ch. 379, codified at Md. Code, Health-Gen. § 19-308.9. The Maryland Health Care Commission is working on the pilot project. See meeting archives at <http://mhcc.maryland.gov> (last visited March 7, 2017).+(last+visited+March+7,+2017).>Google Scholar

Md. Code, Health-Gen. § 19-308.9.Google Scholar

Mass. S.B. 2400 (2012), enacted as 2012 Mass. Legis. Serv. Ch. 224, codified at Mass. Stat. 111 § 227(b) (“The Commissioner shall adopt regulations requiring each licensed hospital, skilled nursing facility, health center or assisted living facility to distribute to appropriate patients in its care information regarding the availability of palliative care and end-of-life options.”).Google Scholar

The Department indicated that the pamphlet must contain at least five components: (1) a definition and explanation of advanced care planning, hospice care and palliative care; (2) FAQs about hospice, palliative care, and patient rights under the law; (3) a MOLST form and explanation; (4) conversation tools to encourage discussions with the patient's family and providers; (5) a list of licensed hospice providers near the facility; and (6) other requirements defined in the guidance of the Department. M. Biondolillo, “Informational Briefing on Proposed Amendments to 105 CMR 130.000, 105 CMR 140.000 and 105 CMR 150.000: Provision of Information on Palliative Care and Endof-Life Options,” October 16, 2013, available at <http://blog.mass.gov/publichealth/wp-content/uploads/sites/11/2013/10/End-of-Life-Care.pdf> (last visited February 1, 2017). (last visited February 1, 2017).' href=https://scholar.google.com/scholar?q=The+Department+indicated+that+the+pamphlet+must+contain+at+least+five+components:+(1)+a+definition+and+explanation+of+advanced+care+planning,+hospice+care+and+palliative+care;+(2)+FAQs+about+hospice,+palliative+care,+and+patient+rights+under+the+law;+(3)+a+MOLST+form+and+explanation;+(4)+conversation+tools+to+encourage+discussions+with+the+patient's+family+and+providers;+(5)+a+list+of+licensed+hospice+providers+near+the+facility;+and+(6)+other+requirements+defined+in+the+guidance+of+the+Department.+M.+Biondolillo,+“Informational+Briefing+on+Proposed+Amendments+to+105+CMR+130.000,+105+CMR+140.000+and+105+CMR+150.000:+Provision+of+Information+on+Palliative+Care+and+Endof-Life+Options,”+October+16,+2013,+available+at++(last+visited+February+1,+2017).>Google Scholar

Massachusetts Department of Public Health, Circular Letter: DHCQ 14-12-623: “Amendments to 105 CMR 130.000: Hospital Licensure, 105 CMR 140.000: Licensure of Clinics and 150.000: Licensing of Long-Term Care Facilities—New Regulations Requiring Distribution of Information Regarding Patients with Serious Advancing Illness (Dec. 10, 2014), <http://www.mass.gov/eohhs/docs/dph/quality/hcq-circular-letters/2014/dhcq-1412623.pdf> (last visited March 7, 2017).+(last+visited+March+7,+2017).>Google Scholar

Hargett v. Vitas Healthcare Corp., No. RG10547255 (Alameda County Superior Court, Cal. filed 6 July 2011).Google Scholar

Law Offices of James Geagan, “Firm Settles Hospice Suit,” <http://jgeaganlaw.com/manu_pages/firm_news.php> (last visited March 7, 2017).+(last+visited+March+7,+2017).>Google Scholar

Mich. S.B. 165 (2013), enacted as 2013 Mich. Legis. Serv. P.A. 57, codified at Mich. Comp. Laws § 333.20403.Google Scholar

Mich. Comp. Laws § 333.20405. See also Kan. S.B. 85 (2017) (requiring disclosure of hospital “futility” policies).Google Scholar

Okla. H.B. 2603, codified at Okla. Stat. tit. 63 § 3163(A).Google Scholar

Pope, T. M., “Legal Briefing: The New Patient Self Determination Act,” Journal of Clinical Ethics 24, no. 2 (2013): 156-167.Google Scholar

United States Conference of Catholic Bishops, Ethical and Religious Directives for Catholic Health Care Services, 5th ed. (2009), available at <http://www.usccb.org/issues-and-action/human-life-and-dignity/health-care/upload/Ethical-Religious-Directives-Catholic-Health-Care-Services-fifth-edition-2009.pdf> (last visited February 2, 2017).+(last+visited+February+2,+2017).>Google Scholar

Uttley, L. et al., Miscarriage of Medicine: The Growth of Catholic Hospitals and the Threat to Reproductive Health Care (New York: ACLU Foundation and MergerWatch Project, 2013).Google Scholar

WAC 246-320-141(5). WSR 14-02-040, S 246-320-141, filed 12/23/13, effective 1/23/14Google Scholar

WAC 246-320-141(6). WSR 14-02-040, S 246-320-141, filed 12/23/13, effective 1/23/14Google Scholar

The state website was not a model of clarity. See <http://www.doh.wa.gov/DataandStatisticalReports/Healthcarein-Washington/HospitalandPatientData/HospitalPolicies> (last visited February 1, 2017). So, in 2016, the ACLU, End-of-Life Washington, and others launched a new website, ClearHealth Washington, to decode the often murky policies. http://www.clearhealthwa.org.+(last+visited+February+1,+2017).+So,+in+2016,+the+ACLU,+End-of-Life+Washington,+and+others+launched+a+new+website,+ClearHealth+Washington,+to+decode+the+often+murky+policies.+http://www.clearhealthwa.org.>Google Scholar

Orentlicher, D. et al., “Clinical Criteria for Physician Aid in Dying,” Journal of Palliative Medicine 19, no. 3 (2016): 259-262; Colo. Rev. Stat. § 28-48-101 to -123; D.C. Act No. A21-0577 Law No. L21-0182 (2017).Google Scholar

Id.Google Scholar

Charo, A., “Physicians and the (Woman's) Body Politic,” New England Journal of Medicine 370, no. 3 (2014): 193-95.CrossRefGoogle Scholar

Daniels, C. et al., “Informed or Misinformed Consent? Abortion Policy in the United States,” Journal of Health Politics, Policy & Law 41, no. 2 (2016): 181-209; C. Daniels, “Informed Consent Project,” available at <http://informedconsentproject.com/> (last visited February 1, 2017).Google Scholar

Pope and Hexum, supra note 46.Google Scholar

National Conference of State Legislatures, “State Coverage for Telehealth Services,” available at <http://www.ncsl.org/research/health/state-coverage-for-telehealth-services.aspx> (last visited February 1, 2017).+(last+visited+February+1,+2017).>Google Scholar

See Hoffmann, D. and Rowthorn, V., “Legal Impediments to the Diffusion of Telemedicine,” Journal of Health Care Law and Policy 14, no. 1 (2011): 1-54.Google Scholar

Kupchynsky, R. J. and Camin, C. S., “Legal Considerations of Telemedicine,” Texas Bar Journal 64 (2001): 20-28, at 24; S. E. Volkert, “Telemedicine: Rx for the Future of Health Care,” Michigan Telecommunications & Technology Law Review 6, no. 1 (2000): 147-246, 215-216.Google Scholar

Pope and Hexum, supra note 46.Google Scholar

Omer, S. B. et al., “Legislative Challenges to School Immunization Mandates, 2009-2012,” JAMA 311, no. 6 (2014): 620-621.CrossRefGoogle Scholar

Colo. H.B. 1288 (2013).Google Scholar

Cal. A.B. 2109 (2012).Google Scholar

Ore. S.B. 132 (2012).Google Scholar

Vt. S.B. 199 (2012).Google Scholar

Wash. H.B. 1015 (2011).Google Scholar

Pope, T. M., “Legal Briefing: Informed Consent,” Journal of Clinical Ethics 21, no. 1 (Spring 2010): 72-82.Google Scholar

See Pope and Hexum, supra note 46; Medical Board of California, Required Written Information Physicians Must Provide Patients in Specific Circumstances, available at <http://www.mbc.ca.gov/Publications/publication_matrix.pdf> (last visited February 1, 2017).+(last+visited+February+1,+2017).>Google Scholar

See, e.g., Sorrel, A., “Conversation Counts,” Texas Medicine 113, no. 3 (Mar. 2016): 41-45 (reporting that mandated disclosures in Texas become outdated and that the relevant state authority cannot keep pace with medical advances); N.J. Division of Consumer Affairs, “Rule Proposal,” 49, no. 1 (Jan. 3, 2017) (deleting specific standards for assessing brain death because they became outdated).Google Scholar

See Sorrel, supra note 135.Google Scholar

McCullough, M., “Breast Cancer Density Laws Mean More Tests, Unclear Benefit,” Philadelphia Inquirer (Aug. 14, 2016) (breast density).Google Scholar

“The Informed Consent Project,” http://informedconsentproject.com (last visited Mar. 7, 2017).Google Scholar

Pope and Hexum, supra note 46. Admittedly, opponents will assert similar objections against PDAs, since they too intrude upon physicians' professional autonomy and discretion.Google Scholar

American College of Physicians, “Statement of Principles on the Role of Governments in Regulating the Patient-Physician Relationship,” available at <http://www.acponline.org/acp_policy/policies/patient_physician_relationship_2012.pdf (last visited Mar. 7, 2017); American College of Obstetricians and Gynecologists, Statement of Policy: Legislative Interference with Patient Care, Medical Decisions, and the Patient-Physician Relationship (May 2013); Brody, J. E., “Law on End-of-Life Care Rankles Doctors,” New York Times, June 6, 2011.Google Scholar

The California statute allow providers to use “information from organizations specializing in end-of-life care that provide information on factsheets and Internet Web sites.” Cal. Health & Safety Code § 442.5(b). But the statute sets no minimum requirements for the accuracy or clarity of such materials.Google Scholar

Ben-Shahar, O. and Schneider, C. E., More Than You Wanted to Know: The Failure of Mandated Disclosure (2014).CrossRefGoogle Scholar

1133, 111th Cong., 1st Sess. (2009) (Wyden)(defining “shared decision making” as a “collaborative process between patient and clinician that engages the patient in decision making, provides patients with information about trade-offs among treatment options, and facilitates the incorporation of patient preferences and values into the medical plan.”). See also Alston, supra note 12; Durand, M.-A. et al., “Incentivizing Shared Decision Making in the USA – Where Are We Now?” Healthcare 3, no. 2 (2014): 97-101. In informed consent, the patient is like the president who can either sign or veto a bill but cannot help craft it.Google Scholar

When patients lack capacity, PDAs may be used by their legally authorized surrogates. Pope, T. M., “Legal Fundamentals of Surrogate Decision Making,” Chest 141, no. 4 (2012): 1074-1081.CrossRefGoogle Scholar

42 U.S.C. § 299b-36(b)(1).Google Scholar

Similar decision tools are being developed for human subjects in the medical research context. See, e.g., Grootens-Wiegers, P., “Comic Strips Help Children Understand Medical Research: Targeting the Informed Consent Procedure to Children's Needs,” Patient Education & Counseling 98, no. 4 (2015): 518-524.Google Scholar

See, e.g., Expert Medical Navigation, Inc. <https://www.exmednav.com> (last visited February 1, 2017); McAneny, B. L., “Report of the Council on Medical Services,” CMS Report 7-A-10: Shared Decision Making (2010), available at <http://www.ama-assn.org/resources/docs/cms/a10-cms-rpt-7.pdf> (last visited February 1, 2017); G. Elwyn et al., “Investing in Deliberation: A Definition and Classification of Decision Support Interventions for People Facing Difficult Health Decisions,” Medical Decision Making 30, no. 6 (2010): 701-711; A. Gorman, “Inviting patients to Help decide their Own Treatment,” Kaiser Health News (March 16, 2015).+(last+visited+February+1,+2017);+McAneny,+B.+L.,+“Report+of+the+Council+on+Medical+Services,”+CMS+Report+7-A-10:+Shared+Decision+Making+(2010),+available+at++(last+visited+February+1,+2017);+G.+Elwyn+et+al.,+“Investing+in+Deliberation:+A+Definition+and+Classification+of+Decision+Support+Interventions+for+People+Facing+Difficult+Health+Decisions,”+Medical+Decision+Making+30,+no.+6+(2010):+701-711;+A.+Gorman,+“Inviting+patients+to+Help+decide+their+Own+Treatment,”+Kaiser+Health+News+(March+16,+2015).>Google Scholar

Durand et al., supra note 143 (stressing “the need to be very clear that the delivery of [PDAs] is not equivalent to shared decision making”).Google Scholar

Washington, HCA, “HCA Certifies First Patient Decision Aids,” (August 22, 2016 (quoting Matt Handley), http://www.hca.wa.gov/about-hca/health-care-authority-certifies-first-patient-decision-aids (last visited March 7, 2017).Google Scholar

Montori, V. et al., “The Optimal Practice of Evidence-Based Medicine: Incorporating Patient Preferences in Practice Guidelines,” JAMA 310, no. 23 (2013): 2503-2504 (warning that PDAs must not “replace clinicians' compassionate and mindful engagement of the patient”). On the other hand, the discretion left to physicians can be abused, for example, by describing a particular option more positively than warranted. L.I. Iezzoni et al., “Survey Shows that at Least Some Physicians Are Not Always Open or Honest with Patients,” Health Affairs 31, no. 2 (2012): 383-391.Google Scholar

“Patient Decision Aids,” Ottawa Research Hospital Institute, available at <http://decisionaid.ohri.ca/AZlist.html> (last visited February 1, 2017).+(last+visited+February+1,+2017).>Google Scholar

Glyn Elwyn at Dartmouth is compiling a broad and comprehensive inventory of PDA developers. More are joining all the time. See, e.g., Australian Commission on Safety and Quality in Healthcare, Corporate Program 2016-2017 (2016).Google Scholar

ACP Decisions, available at <http://www.acpdecisions.org/> (last visited February 1, 2017).+(last+visited+February+1,+2017).>Google Scholar

Decision Box, available at <http://www.decisionbox.ulaval.ca/> (last visited February 1, 2017).+(last+visited+February+1,+2017).>Google Scholar

Health Wise, available at <http://www.healthwise.org/> (last visited February 1, 2017).+(last+visited+February+1,+2017).>Google Scholar

Informed Medical Decisions Foundation, available at <http://www.informedmedicaldecisions.org/> (last visited February 1, 2017).+(last+visited+February+1,+2017).>Google Scholar

Mayo Clinic Shared Decision Making National Resource Center, available at <http://shareddecisions.mayoclinic.org/> (last visited February 1, 2017).+(last+visited+February+1,+2017).>Google Scholar

Option Grid, available at <http://optiongrid.org/> (last visited February 1, 2017).+(last+visited+February+1,+2017).>Google Scholar

<http://sydney.edu.au/medicine/public-health/shdg/resources/decision_aids.php> (last visited March 7, 2017).+(last+visited+March+7,+2017).>Google Scholar

Taylor Healthcare, available at <http://www.dialogmedical.com/> (last visited February 1, 2017) (developer of “iMedConsent”).+(last+visited+February+1,+2017)+(developer+of+“iMedConsent”).>Google Scholar

<http://www.emmisolutions.com> (last visited March 7, 2017).+(last+visited+March+7,+2017).>Google Scholar

Health Dialogue, available at <http://www.healthdialog.com/Main/default> (last visited February 1, 2017).+(last+visited+February+1,+2017).>Google Scholar

Stay Well, available at <http://kramesstaywell.com/Home> (last visited February 1, 2017).+(last+visited+February+1,+2017).>Google Scholar

X-Plain Education, available at <http://www.patient-education.com/> (last visited February 1, 2017) (developer of “X-Plain”).+(last+visited+February+1,+2017)+(developer+of+“X-Plain”).>Google Scholar

The NNT, available at <http://www.thennt.com/> (last visited February 1, 2017).+(last+visited+February+1,+2017).>Google Scholar

Welvie, available at <https://www.welvie.com/index.aspx> (last visited February 1, 2017).+(last+visited+February+1,+2017).>Google Scholar

USDHHS, Agency for Healthcare Research and Quality, available at <http://www.effectivehealthcare.ahrq.gov/ehc/decisionaids/prostate-cancer/Google Scholar

NHS RightCare, available at <http://www.rightcare.nhs.uk/> (last visited February 1, 2017).+(last+visited+February+1,+2017).>Google Scholar

To emphasize the difference between traditional informed consent, many employ the term “shared decision making.” See deBrokart, D., “From Patient Centered to People Powered: Autonomy on the Rise,” BMJ 350, no. h148 (2015): 1-2. Because I contend the legal doctrine of informed consent is malleable enough to evolve to take the shape of shared decision making, I continue to use the term “informed consent.” L. Butcher, “The Patient's Role in Achieving Value,” HFMA Leadership (Spring 2014): 11-21.Google Scholar

See Brehaut et al., supra note 10, at 709 (“Patient decision aids not only present the information…but also prompt decision makers to compare the different decision options, determine which issues are most important to them, and establish what additional information they need.”). So, not any patient pamphlets or literature are PDAs.Google Scholar

See deBrokart, supra note 169.Google Scholar

See, e.g., El-Jawahri, A., “Randomized, Controlled Trial of an Advance Care Planning Video Decision Support Tool for Patients with Advanced Heart Failure,” Circulation 134, no. 1 (2016): 52-60.Google Scholar

Munro, S. et al., “Choosing Treatment and Screening Options Congruent with Calues: Do Decision Aids Help? Sub-analysis of a Systematic Review,” Patient Education and Counseling 99, no. 4 (2016): 491-500; D. Stacey, F. Légaré, N. F. Col et al., “Decision Aids for People Facing Health Treatment or Screening Decisions,” Cochrane Database Systems Review 1, no. CD001431 (2014): 1-335. PDAs can also help overcome heuristics. P. Ubel, “Creating Value in Health by Understanding and Overcoming resistance to Deinnovation,” Health Affairs 34, no. 2 (2015): 239-244.Google Scholar

If clinicians used PDAs, then patients would be getting consistent information, thus reducing variability. Cf. Stil-well, D. L., IMDF Blog, “Shared Decision Making - A Better Way to Encourage Appropriate Use,” (July 14, 2016), available through <http://informedmedicaldecisions.org> (noting high rates of lumbar spinal fusion surgery even though it is no better than non-surgical approaches or simpler surgeries).+(noting+high+rates+of+lumbar+spinal+fusion+surgery+even+though+it+is+no+better+than+non-surgical+approaches+or+simpler+surgeries).>Google Scholar

Arterburn, D. et al., “Introducing Decision Aids at Group Health Was Linked to Sharply Lower Hip and Knee Surgery Rates and Costs,” Health Affairs 31, no. 9 (2012): 2094-2104; A. D. Kennedy et al., “Effects of Decision Aids for Mennoraghia on Treatment Choices, Health Outcomes and Costs,” JAMA 288, no. 21 (2002): 2701-2708.Google Scholar

Veroff, D. et al., “Enhanced Support for Shared Decision Making Reduced Costs of Care for Patients with Preference-Sensitive Conditions,” Health Affairs 32, no. 2 (2013): 285-293.CrossRefGoogle Scholar

Volandes, A. E. et al., “Randomized Controlled Trial of a Video Decision Support Tool for Cardiopulmonary Resuscitation Decision Making in Advanced Cancer,” Journal of Clinical Oncology 31, no. 3 (2013): 380-386; A. E. Volandes et al., “A Randomized Controlled Trial of a Goals-of-Care Video for Elderly Patients Admitted to Skilled Nursing Facilities,” Journal of Palliative Medicine 15, no. 7 (2012): 805-811; J. McCannon et al., “Augmenting Communication and Decision Making in the Intensive Care Unit with a Cardiopulmo-nary Resuscitation Video Decision Support Tool: A Temporal Intervention Study,” Journal of Palliative Medicine 15, no. 12 (2012): 1382-1387; A. El-Jawahri et al., “Use of Video to Facilitate End-of-Life Discussions with Patients with Cancer: A Randomized Controlled Trial,” Journal of Clinical Oncology 28, no. 2 (2010): 305-310.Google Scholar

The Lewin Group, Bending the Curve: Technical Documentation (New York: The Commonwealth Fund 2008), available at <http://www.lewin.com/content/dam/Lewin/Resources/Site_Sections/Publications/3888.pdf> (last visited March 7, 2017); see also L. Trenamon, “The Cost Effectiveness of Patient Decision Aids: A Systematic Review,” Healthcare 2, no. 4 (2014): 251-257.+(last+visited+March+7,+2017);+see+also+L.+Trenamon,+“The+Cost+Effectiveness+of+Patient+Decision+Aids:+A+Systematic+Review,”+Healthcare+2,+no.+4+(2014):+251-257.>Google Scholar

Lindor, R. A. et al., “Liability and Informed Consent in the Context of Shared Decision Making,” Academic Emergency Medicine 23, no. 12 (2016): 1428-1433. There are several ways in which PDAs can reduce liability. For example, PDAs better enable patients to participate in their own healthcare, thus reducing the risk of injury in the first place. A complete analysis is beyond the scope of this Article.Google Scholar

Huntington, B. and Kuhn, N., “Communication Gaffes: A Root Cause of Malpractice Claims,” Baylor University Medical Center Proceedings 16, no. 2 (2003): 157-161; M. Colaco et al., “Influencing Factors Leading to Malpractice Litigation in Radical Prostatectomy,” Journal of Urology 191, no. 6 (2014): 1770-1776.Google Scholar

Stacey, D. et al., “Implementation of a Patient Decision Aid for for Men with Localized Prostate Cancer: Evaluation of Patient Outcomes and Practice Variation,” Implementation Science 11, no. 87 (2016): 1-9.Google Scholar

See, e.g., Moore, P. J. et al., “Medical Malpractice: The Effect of Doctor-Patient Relations on Medical Patient Perceptions and Malpractice Intentions,” Western Journal of Medicine 173, no. 4 (2000): 244-250.Google Scholar

Spiegel, A. D. and Kavaler, F., “Better Patient Communications Mean Lower Liability Exposure,” Managed Care 6, no. 8 (Aug. 1997): 119-124.Google Scholar

The Joint Commission, “Informed Consent: More Than Getting a Signature,” Quick Safety Issue 21 (February 2016), available at <https://www.jointcommission.org/assets/1/23/Quick_Safety_Issue_Twenty-One_February_2016.pdf> (last visited February 1, 2017).+(last+visited+February+1,+2017).>Google Scholar

Institute of Medicine, Crossing the Quality Chasm: A New Health System for the 21st Century (Washington, D.C.: National Academy Press, 2001).Google Scholar

See Alston et al., supra note 12.Google Scholar

Id., at 12.Google Scholar

See Gillick, supra note 10.Google Scholar

Hole-Curry, L., State Legislation Promotes Use of Shared Decisionmaking through Demonstration Project, Learning Collaborative and Recognition of Decision Aids as Informed Consent, AHRQ Health Care Innovations Exchange (August 28, 2013), available at <https://innovations.ahrq.gov/profiles/state-legislation-promotes-use-shared-decisionmaking-through-demonstration-project-learning> (last visited February 1, 2017).+(last+visited+February+1,+2017).>Google Scholar

See Durand et al., supra note 143 (“The well-documented implementation challenge has led to significant interest in developing incentives…”); Trenamon, supra note 179; O'Connor, A. M. et al., “Toward the Tipping Point: Decision Aids and Informed Patient Choice,” Health Affairs 26, no. 3 (2007): 716-725; A. Engelen et al., “Patients' Views on Using Decision Support Tools: A Systematic Review,” European Journal for Person Centered Healthcare 4, no. 1 (2016); C.A. Austin, ”Tools to Promote Shared Decision Making in Serious Illness: A Systematic Review,” JAMA Internal Medicine 175, no. 7 (2015): 1213-1221; J.A. Tulsky, ”Decision Aids in Serious Illness: Moving What Works into Practice,” JAMA Internal Medicine 175, no. 7 (2015): 1221-1222; C.L. Lewis et al., “Developing and Evaluating a Clinic-Based Decision Aid Delivery System,” MMD Policy & Practice 1 (2016): 1–8; M.J. Barry, “Resolving the Decision Aid Paradox,” JAMA Internal Medicine 175, no. 5 (2015): 799-800. See also C. E. Cox et al., “Development and Pilot Testing of a Decision Aid for Surrogates of Patients with Prolonged Mechanical Ventilation,” Critical Care Medicine 40, no. 8 (2012): 2327-2334, at 2327 (“Although the use of shared decision making is endorsed by many major critical care professional societies, its implementation in the intensive care unit is incomplete and infrequent.”); G. Sinha, “Decision Aids Help Patients but Still Are Not Widely Used,” Journal of the National Cancer Institute 106, no. 7 (2014): 6-7; Cf. M. L. Schwarze and M. J. Nabozny, “How People Die in 2014,” Annals Surgery 260, no. 6 (2014): 958-959 (“In contrast to the pace and complexity of technological innovation, innovation in communication has been nearly stagnant.”).CrossRefGoogle Scholar

See Alston et al., supra note 12, at 2.Google Scholar

Id.Google Scholar

See Hole-Curry, supra note 189.Google Scholar

“[T]he road to fully integrating SDM into clinical practice likely will be long and winding.” Alston et al., supra note 12, at 25. While overall use remains low, PDAs are used in some facilities and systems, like the Massachusetts General Hospital and Seattle-based Group Health. See, e.g., Sepucha, K. R., “Ten Years, Forty Decision Aids, and Thousands of Patient Uses: Shared Decision Making at Massachusetts General Hospital,” Health Affairs 35, no. 4 (2016): 630-636; M. Hostetter and S. Klein, Quality Matters: Helping Patients Make Better Treatment Choices with Decision Aids, The Commonwealth Fund (2012).CrossRefGoogle Scholar

See Gawande, A., “Slow Ideas: Some Innovations Spread Fast. How Do You Speed the Ones That Don't?” New Yorker (July 29, 2013).Google Scholar

Lin, G. A. et al., “An Effort to Spread Decision Aids in Five California Primary Care Practices Yielded Low Distribution, Highlighting Hurdles,” Health Affairs 32, no. 2 (2013): 311-320; M. W. Friedberg, “A Demonstration of Shared Decision Making in Primary Care Highlights Barriers to Adoption and Potential Remedies,” Health Affairs 32, no. 2 (2013): 268-275; V. A. Shaffer, “Why Do Patients Derogate Physicians Who Use a Computer-Based Diagnostic Support System?” Medical Decision Making 33, no. 1 (2013): 108-118; D. L. Frosch et al., “Authoritarian Physicians and Patients' Fear of Being Labeled ‘Difficult’ among Key Obstacles to Shared Decision Making,” Health Affairs 31, no. 5 (2012): 1030-1038; see Gillick, supra note 10.Google Scholar

Spatz, E. S. et al., “The New Era of Informed Consent: Getting to a Reasonable Patient through Shared Decision Making,” JAMA 315, no. 19 (2016): 2063-2064. Health information technology can help overcome some of these barriers. For example, at Massachusetts General Hospital when providers enter a new problem into a patient's EHR, a reminder icon appears to indicate the available of a PDA. With a single click the PDA can be prescribed. See Fowler et al., supra note 10, at 701.Google Scholar

See Lin et al., supra note 196; Legare, F. and Witteman, H., “Shared Decision Making: Examining Key Elements and Barriers to Adoption into Routine Clinical Practice,” Health Affairs 32, no. 2 (2013): 276-284; Hole-Curry, supra note 189 (noting the “difficulty of changing entrenched practices” and “the high cost of many SDM tools”); CMS, “Beneficiary Engagement and Incentives: Shared Decision Making (SDM) Model,” available at <https://innovation.cms.gov/initiatives/beneficiary-engagement-sdm> (last visited March 7, 2017) (citing “overworked physicians, insufficient practitioner training, inadequate clinical information systems, lack of consistent methods to measure that shared decision making is taking place, and uncertainty as to whether, or how, to promote change and invest in the time, tools, and training required to achieve meaningful shared decision making.”).Google Scholar

See supra notes 139 to 140 and accompanying text.Google Scholar

Even before the ACA, the Empowering Medicare Choices Act would have required the U.S. Department of Health and Human Services to promulgate regulations establishing standards and requirements for shared decision making under Medicare, based on the results of a pilot program. H.R. 2580, 111th Cong., 1st Sess. (2009) (Blumenauer, D-Ore.); S. 1133, 111th Cong., 1st Sess. (2009) (Wyden, D-Ore.). The companion bills ultimately died in committee.Google Scholar

See Alston et al., supra note 12, at 2.Google Scholar

The stated purpose of this section of the Affordable Care Act is to “facilitate collaborative processes between patients, caregivers or authorized representatives, and clinicians that engages [sic] the patient, caregiver or authorized representative in decision making, provides patients, caregivers or authorized representatives with information about treatment options, and facilitates the incorporation of patient preferences and values into the medical plan.” 42 U.S.C. § 299b-36(a).Google Scholar

42 U.S.C. § 299b-36(d).Google Scholar

42 U.S.C. § 299b-36(e).Google Scholar

See infra Section VI.D. The intended entity appears to have been the National Quality Forum.Google Scholar

42 U.S.C. § 299b-36(e).Google Scholar

In addition to those measures described below, Section 3013 of ACA authorizes DHHS to award grants to develop, improve, update, or expand “quality measures.” 42 U.S.C. § 299b-31. Section 3013 directs DHHS to prioritize those measures that allow the assessment of “use of shared decision making tools.” 42 U.S.C. § 299b-31(c)(2).Google Scholar

ACA § 3021, codified at 42 U.S.C. § 1315a(a).Google Scholar

42 U.S.C. § 1315a(a).Google Scholar

42 U.S.C. § 1315a(c).Google Scholar

42 U.S.C. § 1315a(b)(2)(B)(ix).Google Scholar

See Acumen, Evaluation of the Shared Decision Making (SDM) & Medication Management (MM) Health Care Innovation Awardees: Second Annual Report (March 2016), available at <https://downloads.cms.gov/files/cmmi/hcia-shared-decisionmakingmedicationmnmgt-secondevalrpt.pdf> (last visited February 2, 2017).+(last+visited+February+2,+2017).>Google Scholar

Centers for Medicare & Medicaid Services, Center for Medicare & Medicaid Innovation, “Health Care Innovation Awards,” available at <http://innovation.cms.gov/initiatives/Health-Care-Innovation-Awards/> (last visited February 2, 2017).+(last+visited+February+2,+2017).>Google Scholar

Centers for Medicare & Medicaid Services, Center for Medicare & Medicaid Innovation, “Healthcare Innovation Award Project Profiles,” available at <http://innovation.cms.gov/Files/x/HCIA-Project-Profiles.pdf> (last visited February 2, 2017). A search of the document for the term “decision” turned up a handful of projects with a focus on implementation of shared decision making models, including: (1) MedExpert International, Inc.'s Quality Medical Management System, (2) the Trustees of Dartmouth College's “Patient and Family Activators” project, and (3) Welvie, LLC's “Shared decision making for preference-sensitive surgery” project. [update] 215 42 U.S.C. § 299b-7; USHHS, AHQR, “Who Is Involved in the Effective Health Care Program,” available at <http://www.effectivehealthcare.ahrq.gov/index.cfm/who-is-involved-in-the-effective-health-care-program1/> (last visited February 2, 2017); USHHS, AHQR, “Grants On-Line Database,” available at <http://gold.ahrq.gov/projectsearch/grant_search.jsp> (last visited February 2, 2017). Search in abstract title field for “decision aid” or “decision tool” for AHRQ-funded projects related to patient decision aids. (last visited February 2, 2017); USHHS, AHQR, “Grants On-Line Database,” available at (last visited February 2, 2017). Search in abstract title field for “decision aid” or “decision tool” for AHRQ-funded projects related to patient decision aids.' href=https://scholar.google.com/scholar?q=Centers+for+Medicare+&+Medicaid+Services,+Center+for+Medicare+&+Medicaid+Innovation,+“Healthcare+Innovation+Award+Project+Profiles,”+available+at++(last+visited+February+2,+2017).+A+search+of+the+document+for+the+term+“decision”+turned+up+a+handful+of+projects+with+a+focus+on+implementation+of+shared+decision+making+models,+including:+(1)+MedExpert+International,+Inc.'s+Quality+Medical+Management+System,+(2)+the+Trustees+of+Dartmouth+College's+“Patient+and+Family+Activators”+project,+and+(3)+Welvie,+LLC's+“Shared+decision+making+for+preference-sensitive+surgery”+project.+[update]+215+42+U.S.C.+§+299b-7;+USHHS,+AHQR,+“Who+Is+Involved+in+the+Effective+Health+Care+Program,”+available+at++(last+visited+February+2,+2017);+USHHS,+AHQR,+“Grants+On-Line+Database,”+available+at++(last+visited+February+2,+2017).+Search+in+abstract+title+field+for+“decision+aid”+or+“decision+tool”+for+AHRQ-funded+projects+related+to+patient+decision+aids.>Google Scholar

USHHS, AHQR, “Patient Decision Aids,” available at <http://effectivehealthcare.ahrq.gov/index.cfm/tools-and-resources/patient-decision-aids/> (last visited February 2, 2017).+(last+visited+February+2,+2017).>Google Scholar

Fleurence, R. et al., “How The Patient-Centered Outcomes Research Institute Is Engaging Patients and Others in Shaping its Research Agenda,” Health Affairs 32, no. 2 (2013): 393-400.CrossRefGoogle Scholar

ACA § 6301, codified at 42 U.S.C. § 1320e.Google Scholar

Patient-Centered Outcomes Research Institute, National Priorities for Research and Research Agenda (May 21, 2012), available at <http://www.pcori.org/assets/PCORI-National-Priorities-and-Research-Agenda-2012-05-21-FINAL.pdf> (last visited February 2, 2017).+(last+visited+February+2,+2017).>Google Scholar

Patient-Centered Outcomes Research Institute, PCORI PFA Cycle I Awardees (December 21, 2012), available at <http://www.pcori.org/assets/PFA-Awards-Cycle-1-2012.pdf> (last visited February 2, 2017). At least two studies sought to assess whether decision aids improved the quality of decision making or clinical outcomes (for pediatric type I diabetes, Shared Medical Decision Making in Pediatric Diabetes; for chest pain patients in the emergency department, Shared Decision Making in the Emergency Department: The Chest Pain Trial, at 4). One study sought to develop a decision tool to inform the medical decision making of parents of children with disorders of sex development (Decision Support for Parents Receiving Genetic Information about Child's Rare Disease, at 21).+(last+visited+February+2,+2017).+At+least+two+studies+sought+to+assess+whether+decision+aids+improved+the+quality+of+decision+making+or+clinical+outcomes+(for+pediatric+type+I+diabetes,+Shared+Medical+Decision+Making+in+Pediatric+Diabetes;+for+chest+pain+patients+in+the+emergency+department,+Shared+Decision+Making+in+the+Emergency+Department:+The+Chest+Pain+Trial,+at+4).+One+study+sought+to+develop+a+decision+tool+to+inform+the+medical+decision+making+of+parents+of+children+with+disorders+of+sex+development+(Decision+Support+for+Parents+Receiving+Genetic+Information+about+Child's+Rare+Disease,+at+21).>Google Scholar

See Alston, supra note 12. Current trends suggest that over the next few years, policymakers will further clarify that treatment inconsistent with patient preferences is treatment without benefit. As that proposition becomes more widely accepted, healthcare providers will find it more difficult (if not impossible) to obtain public or private reimbursement for tests and procedures administered without adequate informed consent. Already, two “Stage Two” use “meaningful use” criteria focus on better patient engagement: “7. Provide patients the ability to view online, download and transmit their health information…17. Use secure electronic messaging to communicate with patients on relevant health information.” Centers for Medicare and Medicaid Services, Eligible Professional's Guide to STAGE 2 of the EHR Incentive Programs (September 2013): at 14, available at <http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/Downloads/Stage2_Guide_EPs_9_23_13.pdf> (last visited February 2, 2017). (last visited February 2, 2017).' href=https://scholar.google.com/scholar?q=See+Alston,+supra+note+12.+Current+trends+suggest+that+over+the+next+few+years,+policymakers+will+further+clarify+that+treatment+inconsistent+with+patient+preferences+is+treatment+without+benefit.+As+that+proposition+becomes+more+widely+accepted,+healthcare+providers+will+find+it+more+difficult+(if+not+impossible)+to+obtain+public+or+private+reimbursement+for+tests+and+procedures+administered+without+adequate+informed+consent.+Already,+two+“Stage+Two”+use+“meaningful+use”+criteria+focus+on+better+patient+engagement:+“7.+Provide+patients+the+ability+to+view+online,+download+and+transmit+their+health+information…17.+Use+secure+electronic+messaging+to+communicate+with+patients+on+relevant+health+information.”+Centers+for+Medicare+and+Medicaid+Services,+Eligible+Professional's+Guide+to+STAGE+2+of+the+EHR+Incentive+Programs+(September+2013):+at+14,+available+at++(last+visited+February+2,+2017).>Google Scholar

See DHHS 2014; Durand et al., supra note 143; Lee, E. O. and Emanuel, E. J., “Shared Decision Making to Improve Care and Reduce Costs,” New England Journal of Medicine 368, no. 1 (2013): 6-8.Google Scholar

See Winslow, R., “Heart Beat: Medicare Asks: What Does the Patient Think Is Best?” Wall Street Journal, August 9, 2016.Google Scholar

Centers for Medicare & Medicaid Services (CMS), “Decision Memo for Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439N),” available at <https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=274> (last visited February 2, 2017).+(last+visited+February+2,+2017).>Google Scholar

Centers for Medicare and Medicaid Services, “Decision Memo for Percutaneous Left Atrial Appendage (LAA) Closure Therapy (CAG-00445N),” available at <https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=281> (last visited February 2, 2017).+(last+visited+February+2,+2017).>Google Scholar

Cf. DHHS, “Medicare Program; Comprehensive Care for Joint Replacement Payment Model for Acute Care Hospitals Furnishing Lower Extremity Joint Replacement Services Tuesday,” Federal Register 80 (November 24, 2015): 73,274-73,554, 73,502 (“Many commenters recommended…the use of certified or patient-reported outcome decision aids…Based on the comments we received, we will consider the future development of measures related to shared decision making. Should we decide to implement a shared decision making measure in the future, we will do so through notice-and-comment rulemaking.”). On the other hand, CMS sometimes seems to miss the point of PDAs. For example, a commenter recommended a PDA for dialysis. But CMS simply responded that it “encourages nephrologists and dialysis facilities to discuss treatment options with their patients on an ongoing basis.” DHHS, “Medicare Program; End-Stage Renal Disease Prospective Payment System, and Quality Incentive Program,” Federal Register 80, (Nov. 6, 2015): 68,968-69,077, 69,036.Google Scholar

ACA § 3022, codified at 42 U.S.C. § 1395jjj.Google Scholar

ACA § 3022, codified at 42 U.S.C. § 1395jjj(a-b).Google Scholar

ACA § 3022, codified at 42 U.S.C. § 1395jjj(b) & (d).Google Scholar

ACA § 3022, codified at 42 U.S.C. § 1395jjj(b)(2)(G).Google Scholar

Department of Health & Human Services, “Final Rule: Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations,” Federal Register 76 (November 2, 2011): 67,802-67,990, at 67,828.Google Scholar

CMS SDM Model, supra note 199.Google Scholar

Shafir, A. and Rosenthal, J., Shared Decision Making: Advancing Patient-Centered Care through State and Federal Implementation (2012), Informed Medical Decisions Foundation; D. L. Frosch et al., “Shared Decision Making in the United States: Policy and Implementation Activity on Multiple Fronts,” German Journal for Evidence and Quality in Health Care 105, no. 4 (2011): 305-312.Google Scholar

King, J. and Moulton, B., “Group Health's Participation in a Shared Decision-Making Demonstration Yielded Lessons, Such as Role of Culture Change,” Health Affairs 32, no. 2 (2013): 294-302.Google Scholar

2012 Mass. Acts. Ch. 224 § 19, codified at Mass. Gen. Laws Ann. 12C § 20.Google Scholar

Vt. S.B. 129 (2009) (Lunge); enacted as 2009 Act 49.Google Scholar

Vermont Department of Health, “VERMONT2009: Shared Decision Making: Report to the Legislature on Act 49, Section 4,” January 15, 2010, available at <http://www.leg.state.vt.us/reports/2010ExternalReports/252637.pdf> (last visited February 2, 2017).+(last+visited+February+2,+2017).>Google Scholar

Me. LD 1358 (2009) (Mills), enacted as 2009 Maine Laws Ch. 104. The original bill would have required health insurance carriers and the Maine Care program to implement shared decision making.Google Scholar

Shared Decision Making Study Group for the Dirigo Health Agency's Maine Quality Forum, The Practice and Impact of Shared Decision Making (February 2011), available at <http://muskie.usm.maine.edu/Publications/PHHP/Shared-Decision-Making_Final-Report.pdf> (last visited February 2, 2017). (last visited February 2, 2017).' href=https://scholar.google.com/scholar?q=Shared+Decision+Making+Study+Group+for+the+Dirigo+Health+Agency's+Maine+Quality+Forum,+The+Practice+and+Impact+of+Shared+Decision+Making+(February+2011),+available+at++(last+visited+February+2,+2017).>Google Scholar

“INFORMED CONSENT: Guidelines from the Maine Board of Licensure in Medicine,” available at <maine.gov/md/law-statutes/policies.html> (last visited March 7, 2017).+(last+visited+March+7,+2017).>Google Scholar

Minn. Admin. Rules 4764.0040.Google Scholar

N.J. A.B. 2867 (2016) (Singleton).Google Scholar

Id. (emphasis added).Google Scholar

Conn. H.B. 5193 (2009) (Sayers); Okla. S.B. 1002 (2012) (Adelson).Google Scholar

Minn. S.F. 696, 86th Legis. Sess. (2009); Minn. H.F. 1140, 86th Legis. Sess. (2009); Minn. S.F. 542, 87th Legis. Sess. (2011) (Berglin).Google Scholar

See infra notes 151 to 168.Google Scholar

The American Medical Association Council on Medical Services notes that “the clinical quality and ethical design of patient decision aids will become increasingly important as the concept of shared decision making gains popularity.” See McAneny, supra note 147. Legal commentators have also indicated the need for “credentialed, neutral bodies” to approve the information provided by patient decision aids to address the real potential for “biased” or “misleading” decision aids. See King and Moulton, supra note 234.Google Scholar

See Hole-Curry, supra note 189.Google Scholar

Altschild, J. W., Accreditation, Certification, and Credentialing: Relevant Concerns for U.S. Evaluators: New Directions for Evaluation (Washington, DC: American Evaluation Association and Jossey-Bass, 2015).Google Scholar

See Alston et al., supra note 12, at 15.Google Scholar

Commentators have expressed similar concerns about the development of clinical practice guidelines. See, e.g., Avraham, R., “Overlooked and Underused: Clinical Practice Guidelines and Malpractice Liability For Independent Physicians,” Connecticut Insurace Law Journal 20, no. 2 (2014): 273-333; R. Avraham, “Clinical Practice Guidelines: The Warped Incentives in the U.S. Healthcare System,” American Journal of Law & Medicine 37, no. 1 (2011): 7-40; M. J. Mehlman, “Medical Practice Guidelines as Malpractice Safe Harbors: Illusion or Deceit?” Journal of Law, Medicine & Ethics 40, no. 2 (2012): 286-300. Advance directives are also often developed by nonclinicians, yet meant for implementation by clinicians.Google Scholar

See Alston et al., supra note 12, at 14 (”quality varies widely”).Google Scholar

See supra Section V.A.Google Scholar

Poddar, U. et al., ”Patient Decision Aids: A Case for Certification at the National Level in the United States,” Journal of Clinical Ethics 26, no. 4 (2015): 306-311.Google Scholar

Austin, supra note 191; Tulsky, supra note 191; Poddar, supra note 254, at n.3.Google Scholar

Poddar, supra note 254; Volandes, supra note 75, at 80 (“As with all new technologies, issues regarding quality control will arise…How can be adequately evaluate [PDAs] regarding content, objectivity, point of view, and authenticity?”). Similar calls for clinical practice guidelines. C. Taylor, “The Use of Clinical Practice Guidelines in Determining Standard of Care,” Journal of Legal Medicine 35, no. 2 (2014): 273-290. (describing efforts to evaluate the growing number of CPGs such as AGREE and the National Guidelines Clearinghouse); The AGREE Collaboration, “Development and Validation of an International Appraisal Instrument for Assessing the Quality of Clinical Practice Guidelines,” Quality and Safety in Health Care 12, no. 1 (2003): 18-23; USDDS, AHQR, “National Guideline Clearinghouse,” available at <http://www.guideline.gov> (last visited February 2, 2017).+(last+visited+February+2,+2017).>Google Scholar

Sawicki, N., “Patient Protection and Decision-Aid Quality: Regulatory and Tort Law Approaches,” Arizona Law Review 54, no. 3 (2012): 621-672. Regardless of whether the trend toward shared decision making and the emergence of patient decision aids effectively address all the problems associated with the traditional informed consent framework, it is clear that these changes have important legal implications.Google Scholar

Id. (Sawicki), at 633-635.Google Scholar

Id., at 627.Google Scholar

Id.Google Scholar

See Alston et al., supra note 12, at 15.Google Scholar

Elwyn, G. et al., “Trustworthy Patient Decision Aids: A Qualitative Analysis Addressing the Risk of Competing Interests,” BMJ Open 6, no. 9 (2016): e012562. Cf. Avraham (2011), supra note 251 (discussing conflicts of interest concerning clinical practice guidelines).Google Scholar

See McAneny, supra note 147, at 4; Hansen, S. F., “The Role of Decision Aids in the Affordable Care Act,” Stanford Journal of Public Health (2013), available at <http://web.stanford.edu/group/sjph/cgi-bin/sjphsite/the-role-of-decision-aids-in-theaffordable-care-act/> (last visited February 2, 2017).+(last+visited+February+2,+2017).>Google Scholar

See Sawicki, supra note 257, at 634.Google Scholar

Id., at 634-635.Google Scholar

Id., at 626.Google Scholar

Jaime Staples King and Benjamin Moulton assert that, “a rigorous accreditation process [for patient decision aids], such as the Cochrane System Review, is necessary to protect the interests of physicians and patients.” They note that “[w]hile many creators of decision aids have spent significant time and resources developing their instruments and techniques, these efforts have largely been ad hoc and may differ substantially from one another. Additionally, these aids may be biased toward or against treatments.” See King and Moulton, supra note 44, at 490.Google Scholar

See Brehaut et al., supra note 10; Wennberg, supra note 2.Google Scholar

Elwyn, G. et al., “Developing a Quality Criteria Framework for Patient Decision Aids: Online International Delphi Consensus Process,” BMJ 333, no. 7565 (2006): 417, 1-6; IPDAS, available at <http://ipdas.ohri.ca/> (last visited February 2, 2017).Google Scholar

Elwyn, G. et al., “Assessing the Quality of Decision Support Technologies Using the International Patient Decision Aid Standards Instrument (IPDASi),” PLOS ONE 4, no. 3 (2009): e4705, 1-9.Google Scholar

Ottawa Hospital Research Institute, “Decision Aid Library Inventory (DALI),” available at <http://decisionaid.ohri.ca/cochinvent.php> (last visited February 2, 2017). For an exploration of the decision aids in the Ottawa Hospital Research Institute's Library, see <http://decisionaid.ohri.ca/AZinvent.php> (last visited February 2, 2017). (last visited February 2, 2017).' href=https://scholar.google.com/scholar?q=Ottawa+Hospital+Research+Institute,+“Decision+Aid+Library+Inventory+(DALI),”+available+at++(last+visited+February+2,+2017).+For+an+exploration+of+the+decision+aids+in+the+Ottawa+Hospital+Research+Institute's+Library,+see++(last+visited+February+2,+2017).>Google Scholar

The Joint Commission, Facts about Federal Deemed Status and State Recognition (Nov. 18, 2015), <https://www.joint-commission.org/facts_about_federal_deemed_status_and_state_recognition/> (last visited February 2, 2017).+(last+visited+February+2,+2017).>Google Scholar

Wash. Rev. Code § 41.05.033(1).Google Scholar

Wash. S.B. 5930 (2007), enacted as 2007 Laws Ch. 259, codified at Wash. Rev. Code § 41.05.033. As discussed below, the 2007 legislation also amended state informed consent liability law. Wash. Rev. Code § 7.70.060.Google Scholar

Id.Google Scholar

Wash. H.B. 1311 (2011), enacted as 2011 Laws Ch. 313, codified at Wash. Rev. Code § 70.250.050(1). See Dr. Robert Bree Collaborative, available at <http://www.breecollaborative.org> (last visited February 2, 2017).+(last+visited+February+2,+2017).>Google Scholar

Wash. Rev. Code § 70.250.050(3).Google Scholar

Wash. Rev. Code § 7.70.060(4).Google Scholar

Wash. H.B. 2318 (2012), enacted as 2012 Laws Ch. 101, codified at Wash. Rev. Code § 7.70.060(4).Google Scholar

Wash. Admin. Code §§ 182-60-005 to -030.Google Scholar

Wash. Admin. Code §§ 182-60-025(5).Google Scholar

Wash. Admin. Code §§ 182-60-030.Google Scholar

Washington State Health Care Authority, “Shared Decision Making,” available at <http://www.hca.wa.gov/about-hca/healthier-washington/shared-decision-making> (last visited February 2, 2017).+(last+visited+February+2,+2017).>Google Scholar

See supra notes 270-271.Google Scholar

See supra note 283.Google Scholar

Washington State Health Care Authority, “Patient Decision Aid Certification Criteria,” available at <http://www.hca.wa.gov/assets/program/sdm_cert_criteria.pdf> (last visited March 7, 2017). Additional Criteria for Screening and/Testing, if applicable, require the PDA to: (1) describe what the test is designed to measure, (2) describe next steps taken if test detects a condition/problem, (3) describe next steps if no condition/problem detected, (4) describe consequences of detection that would not have caused problems if the screen was not done, (5) include information about chances of true positive result, (6) include information about chances of true negative result, (7) include information about chances of false negative result. Id.+(last+visited+March+7,+2017).+Additional+Criteria+for+Screening+and/Testing,+if+applicable,+require+the+PDA+to:+(1)+describe+what+the+test+is+designed+to+measure,+(2)+describe+next+steps+taken+if+test+detects+a+condition/problem,+(3)+describe+next+steps+if+no+condition/problem+detected,+(4)+describe+consequences+of+detection+that+would+not+have+caused+problems+if+the+screen+was+not+done,+(5)+include+information+about+chances+of+true+positive+result,+(6)+include+information+about+chances+of+true+negative+result,+(7)+include+information+about+chances+of+false+negative+result.+Id.>Google Scholar

These are specified in an attachment to the application materials.Google Scholar

Washington State Health Care Authority, supra note 287. See also Pope, T. M. and Lessler, D. S., “Revolutionizing Informed Consent: Empowering Patients with Certified Decision Aids,” The Patient — Patient Centered Outcomes Research 10 (forthcoming 2017).Google Scholar

Washington State Health Care Authority, “Patient Decision Aids (PDAs),” available at <http://www.hca.wa.gov/about-hca/healthier-washington/patient-decision-aids-pdas> (last visited February 2, 2017).+(last+visited+February+2,+2017).>Google Scholar

See Hostetter and Klein, supra note 194 (“To achieve implementation of [PDAs]…it will take some combination of leadership commitment, financial support, clinician support, and possibly external pressure via performance measurement or legislative mandate.”) (quoting Karen Sepucha).Google Scholar

Wash. Rev. Code § 7.70.060.Google Scholar

This is my own ballpark estimate. The law does not assign specific percentage values to various burdens of persuasion. McBaine, J. P., “Burden of Proof Degrees of Belief,” California Law Review 32, no. 3 (1944): 242-268. But in one survey of judges, most selected 75% as the appropriate percentage value for “clear and convincing evidence.” M. B. Steinberg, “Burdens of Persuasion: Burdened by Too Many Burdens,” Baltimore Law Forum 23, no. 2 (1992): 3-8, at 6.Google Scholar

See Avraham (2014), supra note 251; see Taylor, supra note 256.Google Scholar

Tex. Civ. Pr. & Rem. Code § 74.106.Google Scholar

Wash. Rev. Code § 7.70.040. See M. Huckaby Lewis et al., “The Locality Rule and the Physician's Dilemma Local Medical Practices vs the National Standard of Care,” JAMA 297, no. 23) (2007): 2633-2637.Google Scholar

New State Ice Co. v. Liebmann, 285 U.S. 262 (1932).Google Scholar

See Alston et al., supra note 12, at 18.Google Scholar

Empowering Medicare Patient Choices Act, S. 1133, 111th Cong., 1st Sess. (2009) (Wyden); H.R. 2580, 111th Cong., 1st Sess. (2009) (Blumenauer).Google Scholar

The bill directed the certification entity to prioritize PDAs for: (1) arthritis of the hip and knee, (2) chronic back pain, (3) chest pain (stable angina), (4) enlarged prostate (benign prostatic hypertrophy, or BPH), (5) Early-stage prostate cancer, (6) early-stage breast cancer, (7) end-of-life care, (8) peripheral vascular disease, (9) gall stones, and (10) threat of stroke from carotid artery disease.Google Scholar

Patient Protection and Affordable Care Act, Pub. L. No. 111-148 (2010), § 3506, codified at 42 U.S.C. § 299b-36.Google Scholar

On the other hand, as discussed above, CMS has incorporated shared decision making as a quality measure benchmark into several programs. See supra notes 221 to 232 and accompanying text.Google Scholar

Gordon & Betty Moore Foundation, NQF to Develop National Standards, Measurement for Patient Decision Aids (January 4, 2016), available at <https://www.moore.org/article-detail?newsUrlName=nqf-to-develop-national-standards-measurement-for-patient-decision-aids> (last visited February 2, 2017).+(last+visited+February+2,+2017).>Google Scholar

National Quality Forum, “Decision Aids Project,” available at <http://www.qualityforum.org/Decision_Aids.aspx> (last visited February 2, 2017).+(last+visited+February+2,+2017).>Google Scholar

National Quality Forum, “About Us,” available at <http://www.qualityforum.org/About_NQF/> (last visited February 2, 2017).+(last+visited+February+2,+2017).>Google Scholar

The NQF is known for having developed a list of 28 medical errors it deemed serious reportable events (more commonly referred to as “never events”).Google Scholar

National Quality Forum, “National Standards for the Certification of Patient Decision Aids,” (Dec. 15, 2016), available at <http://www.qualityforum.org/Publications/2016/12/National_Standards_for_the_Certification_of_Patient_Decision_Aids.aspx> (last visited March 7, 2017).+(last+visited+March+7,+2017).>Google Scholar

See Lee and Emanuel, supra note 222, at 7.Google Scholar

Cf. Gillick, supra note 10 (“Decision aids are perhaps the best hope for rescuing shared decision making from the fate of being a great idea that failed.”).Google Scholar