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Upstream Health Law

Published online by Cambridge University Press:  01 January 2021

Extract

Medicine and health are surprisingly separate. In the introduction to his 1963 master work on medical economics, Kenneth Arrow acknowledged that “the subject is the medical-care industry, not health.” In the 50 years that followed, researchers, policymakers, and public health professionals generated valuable and varied insights into health, impacting both behaviors and environments while addressing social determinants and demographic trends. Yet medical care has followed an even steeper upward trajectory, growing rapidly in scientific precision, public esteem, and technical sophistication.

As a result, the economic gap between the two domains has widened. The U.S. health care system spends almost $3 trillion annually. Preventive screening and early intervention bridge medical care and health, as do nutrition, behavioral health, aging, and a few other fields. But the money is overwhelmingly in medical care, particularly rescue care for those with acute illnesses or serious (and typically preventable) complications of chronic disease.

Type
Symposium
Copyright
Copyright © American Society of Law, Medicine and Ethics 2014

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References

Arrow, K. J., “Uncertainty and the Welfare Economics of Medical Care,” American Economic Review 53, no. 5(1963): 941–973, at 941.Google Scholar
See Safriet, B. J., “Closing the Gap between Can and May in Health-Care Providers' Scope of Practice: A Primer for Policy Makers,” Yale Journal on Regulation 19, no. 2(2002): 301334, at 317 (discussing a Georgia statutory provision that had defined acupuncture as being in “the sole province of those licensed to practice medicine or podiatry”).Google Scholar
Podiatrists, for example, Frequently battle with orthopedic surgeons over where the foot ends and the leg begins. See Safriet, supra note 2, at 320 (“While the arguments sometimes seem to echo the old song about how ‘the leg bone is connected to the thigh bone,’ the resulting determinations have significant practical consequences for podiatrists.”).Google Scholar
Roper, C., “This Woman Invented a Way to Run 30 Lab Tests on Only One Drop of Blood,” Wired, February 18, 2014, available at, <http://www.wired.com/wiredscience/2014/02/elizabeth-holmes-theranos/>(last visited December 2, 2014).(last+visited+December+2,+2014).>Google Scholar
An aphorism often attributed to former president of Columbia University N. Murray Butler is the following: “An expert is one who knows more and more about less and less until he knows absolutely everything about nothing.”Google Scholar
See Stone, R. I., “Providing Long-Term Care Benefits in Cash: Moving to a Disability Model,” Health Affairs 20, no. 6(2001): 96–108, at 96.CrossRefGoogle Scholar
Christensen, C. W., The Innovator's Dilemma (Boston: Harvard Business Review Press, 1997).Google Scholar
Nundy, S.et al, “Mobile Phone Diabetes Project Led to Improved Glycemic Control and Net Savings for Chicago Plan Participants,” Health Affairs 33, no. 2(2014): 265–272, at 266.CrossRefGoogle Scholar
Burg, N., “Inside the New Tech That is Changing How Hospitals Connect with Patients,” Forbes, February 21, 2014, available at <http://www.forbes.com/sites/unify/2014/02/21/connected-hospitals-give-patients-real-time-access-to-health-information/>(last visited December 2, 2014).(last+visited+December+2,+2014).>Google Scholar
Frist, W. H., “Connected Health and the Rise of the Patient-Consumer,” Health Affairs 33, no. 2(2014): 191–193, at 192.CrossRefGoogle Scholar
Dolan, B., “AliveCor Launches Smartphone-Enabled Heart Monitor, Analysis Services Direct-to-Consumer,” MobiHealthNews, February 11, 2014, available at <http://mobihealthnews.com/29801/alivecor-launches-smartphone-enabled-heart-monitor-analysis-services-direct-to-consumer/>(last visited December 2, 2014).(last+visited+December+2,+2014).>Google Scholar
Dolan, B., “WellDoc Raises $20 Million from Merck GHI Fund, Windham,” MobiHealthNews, 2014, available at <http://mobihealthnews.com/28663/welldoc-raises-20-million-from-merck-ghi-fund-windham/>(last visited December 2, 2014).(last+visited+December+2,+2014).>Google Scholar
Press Release, “Theranos Selects Walgreens as a Long-Term Partner Through Which to Offer its New Clinical Laboratory Service,” September 9, 2013, available at <http://online.wsj.com/article/PR-CO-20130909-904497.html>(last visited October 27, 2014);see Roper, supra note 4.(last+visited+October+27,+2014);see+Roper,+supra+note+4.>Google Scholar
Hernandez, D., “Wellframe Wants to Help Fix Your Broken Heart,” Wired, 2013, available at <http://www.wired.com/business/2013/03/wellframe-cardiac-rehab/>(last visited December 2, 2014).(last+visited+December+2,+2014).>Google Scholar
Dolan, B., “South Shore Hospital Taps Wellframe for Mobile-Enabled Cardiac Rehab,” MobiHealthNews, 2014, available at <http://mobihealthnews.com/30051/south-shore-hospital-taps-wellframe-for-mobile-enabled-cardiac-rehab/>(last visited December 2, 2014).(last+visited+December+2,+2014).>Google Scholar
Wellframe, available at <http://www.wellfra.me/>(last visited December 2, 2014).(last+visited+December+2,+2014).>Google Scholar
Dolan, B., “FDA Clears Wireless Home Health App as Class II Medical Device,” MobiHealthNews, 2013, available at <http://mobihealthnews.com/24494/fda-clears-verizon-wireless-home-health-app-as-class-ii-medical-device/>(last visited December 2, 2014).(last+visited+December+2,+2014).>Google Scholar
Dolan, B., “Verizon's FDA-Cleared Patient Engagement App Adds Telcare, Genesis,” MobiHealthNews, 2014, available at <http://mobihealthnews.com/30281/verizons-fda-cleared-patient-engagement-app-adds-telcare-genesis/>(last visited December 2, 2014).(last visited December 2, 2014).' href=https://scholar.google.com/scholar?q=Dolan,+B.,+“Verizon's+FDA-Cleared+Patient+Engagement+App+Adds+Telcare,+Genesis,”+MobiHealthNews,+2014,+available+at+(last+visited+December+2,+2014).>Google Scholar
Press Release, “iPatientCare Announces the Launch of Patient-Centric Wearable Technology App Using Google Glass at Upcoming HiMSS,” 2014, available at <http://exhibitionfloor.himss.org/himss14/public/Booth.aspx?IndexInList=&Upgrade=&FromPage=&BoothID=136416&Task=PressReleaseDetails&PRID=509>(last visited November 7, 2014).(last+visited+November+7,+2014).>Google Scholar
Association of American Medical Colleges, “The Impact of Health Care Reform on the Future Supply and Demand for Physicians Updated Projections through 2025,” 2010, available at <https://www.aamc.org/download/158076/data/updated_projections_through_2025.pdf>(last visited December 2, 2014).(last+visited+December+2,+2014).>Google Scholar
Petterson, S.et al, “Projecting US Primary Care Physician Workforce Needs: 2010–2025,” Annals of Family Medicine 10, no. 6(2012): 503–509, at 503.CrossRefGoogle Scholar
See Sage, W., “The Wal-Martization of Health Care,” Journal of Legal Medicine 28, no. 4(2007): 503519.CrossRefGoogle Scholar
Mehrotra, A. Lave, J. R., “Visits to Retail Clinics Grew Fourfold from 2007 to 2009, Although Their Share of Overall Outpatient Visits Remains Low,” Health Affairs 31, no. 9(2012): 2123–2129, at 2127.CrossRefGoogle Scholar
Sage, W., “Out of the Box: The Future of Retail Medical Clinics,” Harvard Law & Policy Review Online 3, no. 1(2009): 111, available at <http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2377485>(last visited November 7, 2014).Spetz, J.et al, “Scope-Of-Practice Laws for Nurse Practitioners Limit Cost Savings That Can Be Achieved in Retail Clinics,” Health Affairs 32, no. 11(2013):., at 1977.Google Scholar
Takach, M. Witgert, K., “Analysis of State Regulations and Policies Governing the Operation and Licensure of Retail Clinics,” National Academy for State Health Policy (2009): At 7.Google Scholar
Rozga, K., “Retail Health Clinics: How the Next Innovation in Market-Driven Health Care is Testing State & Federal Law,” American Journal of Law & Medicine 35, no. 1(2009): 205–232, at 217.CrossRefGoogle Scholar
New Jersey Administrative Code, 13:37–8.1 (2014);see also American Association of Nurse Practitioners, State Practice Environment: States Categorized by Type, AANP.org, available at <http://www.aanp.org/legislation-regulation/state-legislation-regulation/state-practice-environment/66-legislation-regulation/state-practice-environment/1380-state-practice-by-type>(last visited December 2, 2014).(last+visited+December+2,+2014).>Google Scholar
Takach, M. Witgert, K., “Analysis of State Regulations and Policies Governing the Operation and Licensure of Retail Clinics” National Academy for State Health Policy (2009): At 6, 11.Google Scholar
Id., at 6.Google Scholar
Haugland, D. L. Hughes, P. J., “Retail Health Care Clinics: Filling a Gap in the Health Care System,” in Mason, D. J.et al, eds., Policy and Politics in Nursing and Health Care, 6th ed. (St. Louis: Elsevier, 2014): 252259, at 256.Google Scholar
Pettypiece, S., “Nurse Practitioners, Doctors in Tug-of-War Over Patients,” Business Week, March 7, 2013 (quoting Christie Blanco), available at <http://www.businessweek.com/articles/2013-03-07/nurse-practitioners-doctors-in-tug-of-war-over-patients#p1>(last visited December 2, 2014).(last+visited+December+2,+2014).>Google Scholar
American Association of Nurse Practitioners, “State Practice Environment: States Categorized By Type,” AANP, available at <http://www.aanp.org/legislation-regulation/state-legislation-regulation/state-practice-environment/66-legislation-regulation/state-practice-environment/1380-state-practice-by-type>(last visited December 2, 2014).(last+visited+December+2,+2014).>Google Scholar
Institute of Medicine, The Future of Nursing: Leading Change, Advancing Health (Washington, D.C.: National Academies Press, 2011): At 9.Google Scholar
U.S. Department of Health and Human Services, Health Resources and Services Administration, “Rural Health: Telehealth,” HRSA, available at <http://www.hrsa.gov/ruralhealth/about/telehealth/>(last visited December 2, 2014).(last+visited+December+2,+2014).>Google Scholar
Federal Communications Commission, Rural Health Care Pilot Program, available at <http://www.fcc.gov/encyclopedia/rural-health-care-pilot-program#orders>(last visited December 2, 2014).(last+visited+December+2,+2014).>Google Scholar
Hall, J. L. McGraw, D., “For Telehealth to Succeed, Privacy and Security Risks Must Be Identified and Addressed,” Health Affairs 33, no. 2(2014): 216–221, at 216.CrossRefGoogle Scholar
Federal Communications Commission, National Broadband Plan 206 (2010).Google Scholar
Federation of State Medical Boards, Telemedicine Overview: Board-by-Board Approach, available at <http://www.fsmb.org/pdf/grpol_telemedicine_licensure.pdf>(last visited December 2, 2014).(last+visited+December+2,+2014).>Google Scholar
U.S. Department of Health and Human Services, Health Resources and Services Administration, Health Licensing Board Report to Congress (2010), available at <http://www.hrsa.gov/ruralhealth/about/telehealth/licenserpt10.pdf>(last visited December 2, 2014).(last+visited+December+2,+2014).>Google Scholar
Avery, S. R. Fernandez, M. E., “Identifying the Core Elements of Effective Community Health Worker Programs: A Research Agenda,” American Journal of Public Health 102, no. 9(2012): 1633–1637, at 1633.Google Scholar
Kellerman, A. L.et al, “Primary Care Technicians: A Solution to the Primary Care Workforce Gap,” Health Affairs 32, no. 11(2013): 1893–1898, at 1894.CrossRefGoogle Scholar
Rosenthal, E. L.et al, “Community Health Workers: Part of the Solution,” Health Affairs 29, no. 7(2010): 1338–1342, at 1339.Freudenberg, N. Tsui, E., “Training New Community Health, Food Service, and Environmental Protection Workers Could Boost Health, Jobs, and Growth,” Health Affairs 30, no. 11(2011): 2098–2016, at 2099.CrossRefGoogle Scholar
Centers for Disease Control and Prevention (CDC), State Law Fact Sheet: A Summary of State Community Health Worker Laws 1 (2013), available at <http://www.cdc.gov/dhdsp/pubs/docs/CHW_State_Laws.pdf>(last visited December 2, 2014);see also Institute of Medicine, Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care (Washington, D.C.: National Academies Press, 2002).(last+visited+December+2,+2014);see+also+Institute+of+Medicine,+Unequal+Treatment:+Confronting+Racial+and+Ethnic+Disparities+in+Health+Care+(Washington,+D.C.:+National+Academies+Press,+2002).>Google Scholar
See CDC, supra note 45.Google Scholar
U.S. Department of Health and Human Services, Food and Drug Administration, Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff 13 (September 25, 2013).Google Scholar
Sensible Oversight for Technology Which Advances Regulatory Efficiency (SOFTWARE) Act, H.R. 3303, 113th Cong., 1st Sess. (introduced Oct. 22, 2013).Google Scholar
Hamburg, M. A., Commissioner of Food and Drugs, U.S. Food and Drug Administration, Remarks at the 2013 Health Summit on Mobile Apps and More: Harnessing Technology's Power for Patient Care and Public Health (December 11, 2013).Google Scholar
U.S. Department of Health and Human Services, Food and Drug Administration, Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff (September 25, 2013): At 1318, 20–22.Google Scholar
Consumer Healthcare Products Association & Booze&Co., The Value of OTC Medicine to the United States (January 2012): At 3, available at <http://www.yourhealthathand.org/images/uploads/The_Value_of_OTC_Medicine_to_the_United_States_BoozCo.pdf>(last visited December 2, 2014).(last+visited+December+2,+2014).>Google Scholar
Brookings Engleberg Center for Health Care Reform, Discussion Guide: Exploring Implications of the Nonprescription Safe Use Regulatory Expansion (NSURE) Initiative on Reimbursement and Access (November 4, 2013): At 1, available at <http://www.brookings.edu/∼/media/events/2013/11/04%20nsure%20engelberg/discussion%20guide_nsure%20114.pdf>(last visited December 2, 2014).(last+visited+December+2,+2014).>Google Scholar
Burton, T. M., “FDA to Revamp Approval Path for OTC Drugs,” Wall Street Journal (February 21, 2014), available at <http://online.wsj.com/news/articles/SB10001424052702304275304579395813156008466?mg=reno64-wsj&url=http%3A%2F%2Fonline.wsj.com%2Farticle%2FSB10001424052702304275304579395813156008466.html>(last visited December 2, 2014; access limited).(last+visited+December+2,+2014;+access+limited).>Google Scholar
“Over-The-Counter Drug Monograph System–Past, Present, and Future,” Federal Register 79 (February 24, 2014): 10168, 10170.Google Scholar
See Downing, N. S. Ross, J. S., “Innovation, Risk, and Patient Empowerment: The FDA-Mandated Withdrawal of 23andMe's Personal Genome Service,” JAMA 311, no. 8(2014): 793.Hughes, A. L., “Me, My Genome, and 23andMe,” New Atlantis 40 (2013): 3–18, at 3.CrossRefGoogle Scholar
Burkle, C. M., “The Advance of the Retail Health Clinic Market: The Liability Risk Physicians May Potentially Face When Supervising or Collaborating with Other Professionals,” Mayo Clinic Proceedings 86, no. 11(2011): 1086–1091, at 1088.CrossRefGoogle Scholar
Hoffman, D. Rowthorn, V., “Legal Impediments to the Diffusion of Telemedicine,” Journal of Health Care Law & Policy 14, no. 1(2011): 1–53, at 38.Google Scholar
Hoffman, D. Rowthorn, V., “Legal Impediments to the Diffusion of Telemedicine,” Journal of Health Care Law & Policy 14, no. 1(2011): 1–53, at 38.Google Scholar
Magrabi, F. On, M. Runciman, W. Coiera, E., “Patient Safety Problems Associated with Healthcare Information Technology: An Analysis of Adverse Events Reported to the US Food and Drug Administration,” AMIA Annual Symposium Proceeding 853 (2011). According to the organizers of the Maryland roundtable: “[L]iability for equipment failure would generally lie with the entity that established and services the connection and…such liability should be addressed in any agreements that the entity enters into with providers….[A]llocation of liability should also be disclosed to patients and…if it is not, issues of apparent agency would most likely arise, resulting as a practical matter in liability for all involved.”.Hoffman, D. Rowthorn, V., “Legal Impediments to the Diffusion of Telemedicine,” Journal of Health Care Law & Policy 14, no. 1(2011): 1–53, at 38.Google Scholar
Id. (Hoffman and Rowthorn), at 36.Google Scholar
Cal. Bus. & Prof. Code § 2290.5(b) (2011).Google Scholar
Casey v. 23andMe, Inc., Case No. 13CV2847H (S.D. Cal., filed Nov. 27, 2013).Google Scholar
Adler-Milstein, J.et al, “Telehealth among US Hospitals: Several Factors, Including State Reimbursement and Licensure Policies, Influence Adoption,” Health Affairs 33, no. 2(2014): 207215, at 213.CrossRefGoogle Scholar
Shields, M. C.et al, “A Model for Integrating Independent Physicians into Accountable Care Organizations,” Health Affairs 30, no. 1(2011): 161–172, at 161.CrossRefGoogle Scholar
Centers for Medicare and Medicaid Services, “Telehealth Services: Rural Health Fact Sheet Series,” December 2012, at 1, available at <http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/TelehealthSrvcsfctsht.pdf>(last visited December 2, 2014).(last+visited+December+2,+2014).>Google Scholar
See American Telemedicine Association, “States with Parity Laws for Private Insurance Coverage of Telemedicine,” 2014, available at <http://www.americantelemed.org/docs/default-source/policy/ata-map-telemedicine-parity-2014-3-7.pdf?sfvrsn=0>(last visited December 2, 2014).(last+visited+December+2,+2014).>Google Scholar
45 C.F.R. § 160.102, 160.103 (2012).CrossRefGoogle Scholar
Hall, J. L. McGraw, D., “For Telehealth to Succeed, Privacy and Security Risks Must Be Identified and Addressed,” Health Affairs 33, no. 2(2014): 216–221, at 218.CrossRefGoogle Scholar
For a more detailed discussion, see Yang, Y. T. Silverman, R. D., “Mobile Health Applications: The Patchwork of Legal and Liability Issues Suggests Strategies to Improve Oversight,” Health Affairs 33, no 2(2014): 222–227, at 224.CrossRefGoogle Scholar
Sage, W. M., “Getting the Product Right: How Competition Policy Can Improve Health Care Markets,” Health Affairs 33, no. 6(2014): 10761082.CrossRefGoogle Scholar
Gourevitch, M. N., “Population Health and the Academic Medical Center: The Time Is Right,” Academic Medicine 89, no. 4(2014): 544–549, at 544.CrossRefGoogle Scholar