John, Y. J., “The Streetlight Effect: A Metaphor for Knowledge and Ignorance,” March 21, 2016, available at <https://www.3quarksdaily.com/3quarksdaily/2016/03/the-street-light-effect-a-metaphor-for-knowledge-and-ignorance.html> (last visited October 19, 2019); Freedman, D. H., “Why Scientific Studies So Often Are Wrong: The Streetlight Effect,” Discover Magazine, December 10, 2010, available at <http://discovermagazine.com/2010/jul-aug/29-why-scientific-studies-often-wrong-streetlight-effect> (last visited October 19, 2019).+(last+visited+October+19,+2019);+Freedman,+D.+H.,+“Why+Scientific+Studies+So+Often+Are+Wrong:+The+Streetlight+Effect,”+Discover+Magazine,+December+10,+2010,+available+at++(last+visited+October+19,+2019).>Google Scholar

Doniger, W., The Hindus: An Alternative History (New York: Penguin Press, 2009): 17.Google Scholar

Newquist, D. D. et al., “Beware of Data Gaps in Home Care Research: The Streetlight Effect and Its Implications for Policy Making on Long-Term Services and Support,” Medical Care Research and Review 72, no. 5 (2015): 622–640.CrossRefGoogle Scholar

Victor, D., “Climate Change: Embed the Social Sciences in Climate Policy,” Nature 520, no. 7545 (2015): 27–29, available at <https://www.nature.com/news/climate-change-embed-the-social-sciences-in-climate-policy-1.17206> (last visited October 18, 2019).CrossRefGoogle Scholar

Breger, M. J. et al., “Providing Economic Incentives in Environmental Regulation,” Yale Journal on Regulation 8, no. 2 (1991): 463–495.Google Scholar

Sutton, V., “Commentary on ‘Responsible Conduct by Life Scientists in an Age of Terrorism,’” Science and Engineering Ethics 15, no. 3 (2009): 303–309.CrossRefGoogle Scholar

See Evans, B. J., “The First Amendment Right to Speak About the Human Genome,” University of Pennsylvania Journal of Constitutional Law 16, no. 7 (2014): 549–636, at 618-623 (summarizing case law rejecting regulatory strategies that block information flows as a means of regulating activities that rely on those information flows); see also Central Hudson Gas & Electric Corp. v. Public Service Commission of New York, 447 U.S. 557, 566 (1980) (requiring restrictions on commercial speech to be narrowly tailored and no more extensive than is necessary to directly advance a substantial governmental interest).Google Scholar

U.S. Department of Health and Human Services (DHHS), Secretary's Advisory Committee on Genetics, Health, & Society (SACGHS), U.S. System of Oversight of Genetic Testing (2008): at 17, available at <https://osp.od.nih.gov/wp-content/uploads/2013/11/SACGHS_oversight_report.pdf> (last visited October 20, 2019). (last visited October 20, 2019).' href=https://scholar.google.com/scholar?q=U.S.+Department+of+Health+and+Human+Services+(DHHS),+Secretary's+Advisory+Committee+on+Genetics,+Health,+&+Society+(SACGHS),+U.S.+System+of+Oversight+of+Genetic+Testing+(2008):+at+17,+available+at++(last+visited+October+20,+2019).>Google Scholar

Id.Google Scholar

Id. at 17–20 (citing and reviewing some of this literature).Google Scholar

Id. at 20.Google Scholar

Annas, G. J. et al., “Drafting the Genetic Privacy Act: Science, Policy, and Practical Considerations,” Journal of Law, Medicine & Ethics 23, no. 4 (1995): 360–366, at 365.CrossRefGoogle Scholar

See Kearney, J. D. and Merrill, T. W., “The Great Transformation of Regulated Industries Law,” Columbia Law Review 98, no. 6 (1998): 1323–1409 (discussing the development of U.S. regulatory frameworks since formation of the Interstate Commerce Commission to regulate railroads in the late 19th century).CrossRefGoogle Scholar

See National Academies of Science, Engineering, and Medicine, Preparing for Future Products of Biotechnology (Washington, D.C., National Academies Press, 2017), at 70.Google Scholar

Id.Google Scholar

Office of Science and Technology Policy, Coordinated Framework for Regulation of Biotechnology, Federal Register 51 (1986): 23, 302-50.Google Scholar

Office of Science and Technology Policy, Exercise of Federal Oversight Within Scope of Statutory Authority: Planned Introductions of Biotechnology Products into the Environment, Federal Register 57 (1992): 6753–62.Google Scholar

Executive Office of the President, Modernizing the Regulatory System for Biotechnology Products: Final Version of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology (2017), available at <https://obamawhite-house.archives.gov/sites/default/files/microsites/ostp/2017_coordinated_framework_update.pdf> (last visited October 20, 2019).+(last+visited+October+20,+2019).>Google Scholar

Waltz, E., “Gene-edited CRISPR Mushroom Escapes U.S. Regulation,” Nature 532, no. 7599 (2016): 293.Google Scholar

Health Insurance Portability and Accountability Act of 1996, Pub. L. No. 104-191, 110 Stat. 1936 (codified as amended in scattered sections of 18, 26, 29 and 42 U.S.C.).Google Scholar

45 C.F.R. pts. 160, 164.Google Scholar

Kohane, I. S. et al., “Taxonomizing, Sizing, and Overcoming the Incidentalome,” Genetics in Medicine 14, no. 4 (2012): 399–404, at 403; Department of Health & Human Services (DHHS), Food & Drug Administration (FDA), Optimizing FDA's Regulatory Oversight of Next Generation Sequencing Diagnostic Tests — Preliminary Discussion Paper (December 29, 2014), available at <www.fda.gov/downloads/medicalde-vices/newsevents/workshopsconferences/ucm427869.pdf> (last visited October 20, 2019).CrossRefGoogle Scholar

Dewey, F. E. et al., “Clinical Interpretation and Implications of Whole-Genome Sequencing,” JAMA 311, no. 10 (2014): 1035–1045, at 1040.Google Scholar

Genetic Information Nondiscrimination Act of 2008 (GINA), Pub. L. 110–233, 122 Stat. 881 (May 21, 2008).Google Scholar

See GINA § 102 (amending the Public Health Service Act at 42 U.S.C. § 300gg-91b(d)(16) to define “genetic information” very broadly as including “with respect to any individual, information about — (i) such individual's genetic tests, (ii) the genetic tests of family members of such individual, and (iii) the manifestation of a disease or disorder in family members of such individual” and further including “genetic services and participation in genetic research”); id. at § 300gg-91(d)(17) (defining “genetic test” as referring to “an analysis of human DNA, RNA, chromosomes, proteins, or metabolites, that detects genotypes, mutations, or chromosomal changes” and thus clearly including non-clinically-significant information, such as raw genomic data, within the scope of information included in GINA's definition of “genomic information”); id. at § 300gg-91(d)(18) (defining “genetic services” as including genetic tests and “genetic counseling (including obtaining, interpreting, or assessing genetic information)” and genetic information, such that information from testing, assessing, and counseling occurring during the course of genetic research is included in GINA's broad definition of “genetic information”).Google Scholar

See GINA § 105.Google Scholar

See, e.g., Congressional Record — House, at 2979 (remarks of Rep. Speier, characterizing the passage of GINA as a “strong step” toward protecting sensitive genetic information but stressing that “no journey is completed in just one step” and calling for further work to address “the underlying problems not fixed by this bill, so we can truly protect Americans’ privacy…”).Google Scholar

Clayton, E. W. et al., “The Law of Genetic Privacy: Applications, Implications, and Limitations,” Journal of Law & the Biosciences 6, no. 1 (2019): 1–36, available at <https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3384321> (visited October 19, 2019).CrossRefGoogle Scholar

Federal Bureau of Investigation, Frequently Asked Questions on CODIS and NDIS, available at <https://www.fbi.gov/services/laboratory/biometric-analysis/codis/codis-and-ndis-fact-sheet> (last visited October 20, 2019).+(last+visited+October+20,+2019).>Google Scholar

45 C.F.R. pt. 46, subpt. A.Google Scholar

See National Committee on Vital and Health Statistics, Recommendation Letter to the Secretary on HIPAA Minimum Necessary Standard (Nov. 9, 2016), available at <https://ncvhs.hhs.gov/rrp/november-9-2016-letter-to-the-secretary-recommendation-on-the-hipaa-minimum-necessary-standard/> (last visited October 20, 2019) (discussing problems with the Privacy Rule's approach to de-identified data); Evans, B. J. and Jarvik, G. P., “Impact of HIPAA's Minimum Necessary Standard on Genomic Data Sharing,” Genetics in Medicine (2017), available at <https://www.nature.com/articles/gim2017141?draft=journal> (last visited October 19, 2019) (discussing non-consensual data sharing under HIPAA). (last visited October 19, 2019) (discussing non-consensual data sharing under HIPAA).' href=https://scholar.google.com/scholar?q=See+National+Committee+on+Vital+and+Health+Statistics,+Recommendation+Letter+to+the+Secretary+on+HIPAA+Minimum+Necessary+Standard+(Nov.+9,+2016),+available+at++(last+visited+October+20,+2019)+(discussing+problems+with+the+Privacy+Rule's+approach+to+de-identified+data);+Evans,+B.+J.+and+Jarvik,+G.+P.,+“Impact+of+HIPAA's+Minimum+Necessary+Standard+on+Genomic+Data+Sharing,”+Genetics+in+Medicine+(2017),+available+at++(last+visited+October+19,+2019)+(discussing+non-consensual+data+sharing+under+HIPAA).>Google Scholar

See National Academies of Science, Engineering, and Medicine, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research (Washington, DC, National Academies Press, 2009), at 16 (finding that the HIPAA Privacy Rule is criticized both for failing to protect privacy adequately while also impeding important health research).Google Scholar

45 C.F.R. § 164.524.Google Scholar

See Department of Health & Human Services, Standards for Privacy of Individually Identifiable Health Information, Federal Register 65 (2000): 82,462-831 (codified at 45 C.F.R. pts. 160, 164) (promulgating the HIPAA Privacy Rule and including the access right at 45 C.F.R. § 164.524).Google Scholar

Department of Health & Human Services, Centers for Medicare & Medicaid Services, Centers for Disease Control and Prevention, Office for Civil Rights, CLIA Program and HIPAA Privacy Rule; Patients’ Access to Test Reports, Federal Register 79 (2014): 7290–317 (to be codified at 42 C.F.R. pt. 493 and 45 C.F.R. pt. 164).Google Scholar

See, e.g., Fair Credit Reporting Act of 1970, 15 U.S.C. § 1681 (authorizing the collection and storage of people's financial and credit data without their consent to facilitate a well-functioning credit market and, in return, granting individuals specific civil rights including a right of access to their data); see also U.S. Department of Health, Education, and Welfare, Report of the Secretary's Advisory Committee on Automated Personal Data Systems, Records, Computers, and the Rights of Citizens (DHEW Publication No. (OS) 73-94) (1973), available at <https://www.justice.gov/opcl/docs/rec-com-rights.pdf> (last visited October 20, 2019) (announcing an influential Code of Fair Information Practices (FIPs) based on five principles, one of which is that “[t]here must be a way for an individual to find out what information about him is in a record and how it is used,” id. at 41); Cate, F. H., “The Failure of Fair Information Practice Principles,” in Consumer Protection in the Age of the Information Economy (Winn, J. K., ed.) (New York: Routledge, 2006): 341–377 (tracing subsequent development of FIPs, including access rights, after the 1973 HEW Code of FIPs); Privacy Act of 1974, 5 U.S.C. § 552(a)(d) (providing an individual right of access to data held in governmental databases, including governmentally held Medicare data); Privacy Protection Study Commission, Personal Privacy in an Information Society (July 1977), available at <https://www.ncjrs.gov/pdffiles1/Digitization/49602NCJRS.pdf> (last visited October 20, 2019) (treating individual access rights as a core privacy protection in a report that heavily influenced subsequent development of the HIPAA Privacy Rule); Department of Health & Human Services, Confidentiality of Individually-Identifiable Health Information: Recommendation of the Secretary of HHS Pursuant to Sec. 264 of the Health Insurance Portability and Accountability Act of 1996, § I.G (Sept. 11, 1997), available at Healthcare Compliance Rep. (CCH) ¶ 100,001, 1997 WL 354007170 (hereinafter “DHHS, HIPAA Recommendations”) (citing the Privacy Protection Study Commission’s 1977 recommendations and calling for individual access rights in the report to Congress that set the roadmap for the HIPAA Privacy Rule). (last visited October 20, 2019) (announcing an influential Code of Fair Information Practices (FIPs) based on five principles, one of which is that “[t]here must be a way for an individual to find out what information about him is in a record and how it is used,” id. at 41); Cate, F. H., “The Failure of Fair Information Practice Principles,” in Consumer Protection in the Age of the Information Economy (Winn, J. K., ed.) (New York: Routledge, 2006): 341–377 (tracing subsequent development of FIPs, including access rights, after the 1973 HEW Code of FIPs); Privacy Act of 1974, 5 U.S.C. § 552(a)(d) (providing an individual right of access to data held in governmental databases, including governmentally held Medicare data); Privacy Protection Study Commission, Personal Privacy in an Information Society (July 1977), available at (last visited October 20, 2019) (treating individual access rights as a core privacy protection in a report that heavily influenced subsequent development of the HIPAA Privacy Rule); Department of Health & Human Services, Confidentiality of Individually-Identifiable Health Information: Recommendation of the Secretary of HHS Pursuant to Sec. 264 of the Health Insurance Portability and Accountability Act of 1996, § I.G (Sept. 11, 1997), available at Healthcare Compliance Rep. (CCH) ¶ 100,001, 1997 WL 354007170 (hereinafter “DHHS, HIPAA Recommendations”) (citing the Privacy Protection Study Commission’s 1977 recommendations and calling for individual access rights in the report to Congress that set the roadmap for the HIPAA Privacy Rule).' href=https://scholar.google.com/scholar?q=See,+e.g.,+Fair+Credit+Reporting+Act+of+1970,+15+U.S.C.+§+1681+(authorizing+the+collection+and+storage+of+people's+financial+and+credit+data+without+their+consent+to+facilitate+a+well-functioning+credit+market+and,+in+return,+granting+individuals+specific+civil+rights+including+a+right+of+access+to+their+data);+see+also+U.S.+Department+of+Health,+Education,+and+Welfare,+Report+of+the+Secretary's+Advisory+Committee+on+Automated+Personal+Data+Systems,+Records,+Computers,+and+the+Rights+of+Citizens+(DHEW+Publication+No.+(OS)+73-94)+(1973),+available+at++(last+visited+October+20,+2019)+(announcing+an+influential+Code+of+Fair+Information+Practices+(FIPs)+based+on+five+principles,+one+of+which+is+that+“[t]here+must+be+a+way+for+an+individual+to+find+out+what+information+about+him+is+in+a+record+and+how+it+is+used,”+id.+at+41);+Cate,+F.+H.,+“The+Failure+of+Fair+Information+Practice+Principles,”+in+Consumer+Protection+in+the+Age+of+the+Information+Economy+(Winn,+J.+K.,+ed.)+(New+York:+Routledge,+2006):+341–377+(tracing+subsequent+development+of+FIPs,+including+access+rights,+after+the+1973+HEW+Code+of+FIPs);+Privacy+Act+of+1974,+5+U.S.C.+§+552(a)(d)+(providing+an+individual+right+of+access+to+data+held+in+governmental+databases,+including+governmentally+held+Medicare+data);+Privacy+Protection+Study+Commission,+Personal+Privacy+in+an+Information+Society+(July+1977),+available+at++(last+visited+October+20,+2019)+(treating+individual+access+rights+as+a+core+privacy+protection+in+a+report+that+heavily+influenced+subsequent+development+of+the+HIPAA+Privacy+Rule);+Department+of+Health+&+Human+Services,+Confidentiality+of+Individually-Identifiable+Health+Information:+Recommendation+of+the+Secretary+of+HHS+Pursuant+to+Sec.+264+of+the+Health+Insurance+Portability+and+Accountability+Act+of+1996,+§+I.G+(Sept.+11,+1997),+available+at+Healthcare+Compliance+Rep.+(CCH)+¶+100,001,+1997+WL+354007170+(hereinafter+“DHHS,+HIPAA+Recommendations”)+(citing+the+Privacy+Protection+Study+Commission’s+1977+recommendations+and+calling+for+individual+access+rights+in+the+report+to+Congress+that+set+the+roadmap+for+the+HIPAA+Privacy+Rule).>Google Scholar

See Press Release, U.S. Department of Health & Human Services, HHS Strengthens Patients’ Right to Access Lab Test Reports, February 3, 2014), available at <https://perma.cc/AJ83-2Q59> (last visited October 20, 2019) (labeling HIPAA's individual access right as the “cornerstone of the Privacy Rule”).+(last+visited+October+20,+2019)+(labeling+HIPAA's+individual+access+right+as+the+“cornerstone+of+the+Privacy+Rule”).>Google Scholar

See Evans, B. J., “The Genetic Information Nondiscrimination Act at Age 10: GINA's Controversial Assertion that Data Transparency Protects Privacy and Civil Rights,” William & Mary Law Review 60, no. 6 (2019): 2017–2109, at 2055-65 (reviewing statements by Congress, regulators, and congressional advisory bodies on the importance of access as a privacy protection).Google Scholar

Department of Health & Human Services, Standards for Privacy of Individually Identifiable Health Information, Proposed Rules, Federal Register 64 (1999): 59,918-60,067, at 59,980 (noting, in the preamble to the proposed Privacy Rule, that the right to inspect and copy one's data “is a fundamental aspect of protecting privacy”).Google Scholar

See DHHS, HIPAA Recommendations, supra note 38, at § I.G (noting that the “decision whether to disclose a record may depend on what the record says, and so access to the record is integral to making an informed choice to disclose information”).Google Scholar

See, e.g., California Consumer Privacy Act of 2018, § 2 (noting that “it is the intent of the Legislature to further Californians’ right to privacy by giving consumers an effective way to control their personal information, by ensuring the following rights… [including] … The right of Californians to access their personal information….”); id. at § 3 (amending Part 4 of Division 3 of the Civil Code to add § 1798.100(d) (providing individuals with a right of access to their data); see also Minnesota Statutes § 13.04 (2018), Rights of subjects of data.Google Scholar

See, e.g., European Union General Data Protection Regulation (Regulation (EU) 2016/679), Art. 15.Google Scholar

National Academies of Science, Engineering, and Medicine, Returning Individual Research Results to Participants: Guidance for a New Research Paradigm (Washington, DC, National Academies Press, 2018), available at <http://nationalacademies.org/hmd/reports/2018/returning-individual-research-results-to-participants.aspx?_ga=2.125510026.1285413390.1534711400-1676621809.1532099289> (last visited October 20, 2019).+(last+visited+October+20,+2019).>Google Scholar

See Evans, B. J. and Wolf, S. M., “A Faustian Bargain That Undermines Research Participants' Privacy Rights and Return of Results,” Florida Law Review 71, no. 5 (2019): 1281–1345, available at <https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3368555> (last visited October 20, 2019) (discussing HIPAA-related recommendations of the National Academies report, supra note 44, and how those recommendations would reduce existing privacy protections for genomic information).Google Scholar

National Institutes of Health (NIH), Consent to Join the All of Us Research Program (June 20, 2018) at F1-8 — F1-9, available at <https://allofus.nih.gov/sites/default/files/primary_consent_form_eng_sample.pdf> (visited October 20, 2019).+(visited+October+20,+2019).>Google Scholar

Id. at F1-8.Google Scholar

Id. at F1-9.Google Scholar

Id.Google Scholar

Id. (emphasis added).Google Scholar

See U.S. Dep’t of Health and Human Servs., Off. for Civil Rights, Individuals’ Right under HIPAA to Access their Health Information 45 CFR § 164.524 (February 25, 2016), available at <https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/access/index.html> (last visited July 24, 2017).+(last+visited+July+24,+2017).>Google Scholar

NIH, supra note 46, at F1-9.Google Scholar

National Institutes of Health-Department of Energy Working Group on Ethical, Legal & Social Implications of Human Genome Research, Task Force on Genetic Testing, Holtzman, N. A. and Watson, M. S. eds., Promoting Safe and Effective Genetic Testing in the United States (1997): at ch. 2, available at <https://www.genome.gov/10001733/genetic-testing-report> (last visited June 6, 2019).+(last+visited+June+6,+2019).>Google Scholar

National Institutes of Health, Secretary's Advisory Committee on Genetic Testing, Enhancing the Oversight of Genetic Tests: Recommendations of the SACGT (2000): at 10–11, available at <https://osp.od.nih.gov/wp-content/uploads/2013/11/oversight_report.pdf> (last visited June 4, 2019). (last visited June 4, 2019).' href=https://scholar.google.com/scholar?q=National+Institutes+of+Health,+Secretary's+Advisory+Committee+on+Genetic+Testing,+Enhancing+the+Oversight+of+Genetic+Tests:+Recommendations+of+the+SACGT+(2000):+at+10–11,+available+at++(last+visited+June+4,+2019).>Google Scholar

Evans, B. J. et al., “How Can Law and Policy Advance Quality in Genomic Analysis and Interpretation for Clinical Care,” Journal of Law, Medicine & Ethics 48, no. 1 (2020): 44–68.CrossRefGoogle Scholar

See id. at 46.Google Scholar

Clinical Laboratory Improvement Amendments of 1988, Pub. L. No. 100-578, 102 Stat. 2903, codified as amended at 42 U.S.C. § 263a.Google Scholar

42 C.F.R. pt. 493.Google Scholar

See DHHS, FDA, supra note 22, at 1.Google Scholar

National Institutes of Health, Conference: Return of Genetic Results in the All of Us Research Program (March 7, 2017), available at <https://videocast.nih.gov/summary.asp?Live=21887&bhcp=1> (Day 2, 8 a.m. Session, at 1:16:55) (last visited October 20, 2019) (statement by Karen Dyer, Director, Center for Clinical Standards and Quality, CMS (ellipsis in the original)).+(Day+2,+8+a.m.+Session,+at+1:16:55)+(last+visited+October+20,+2019)+(statement+by+Karen+Dyer,+Director,+Center+for+Clinical+Standards+and+Quality,+CMS+(ellipsis+in+the+original)).>Google Scholar

Evans, supra note 39, at 2106-2107.Google Scholar

See Evans et al., supra note 55, at 57; see also DHHS, FDA, Transcript of a Workshop, Optimizing FDA's Oversight of Next-Generation Sequencing Diagnostic Tests (February 20, 2015), available at <http://wayback.archive-it.org/7993/20170113000324/ http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM439974.pdf> (last visited October 20, 2019), at 3, 20–21 (noting that genomic testing allows “broad and indication-blind testing” and explaining why this stymies FDA's traditional processes for ensuring tests are safe and effective in their intended uses). (last visited October 20, 2019), at 3, 20–21 (noting that genomic testing allows “broad and indication-blind testing” and explaining why this stymies FDA's traditional processes for ensuring tests are safe and effective in their intended uses).' href=https://scholar.google.com/scholar?q=See+Evans+et+al.,+supra+note+55,+at+57;+see+also+DHHS,+FDA,+Transcript+of+a+Workshop,+Optimizing+FDA's+Oversight+of+Next-Generation+Sequencing+Diagnostic+Tests+(February+20,+2015),+available+at++(last+visited+October+20,+2019),+at+3,+20–21+(noting+that+genomic+testing+allows+“broad+and+indication-blind+testing”+and+explaining+why+this+stymies+FDA's+traditional+processes+for+ensuring+tests+are+safe+and+effective+in+their+intended+uses).>Google Scholar

See, e.g., discussion infra this article, at 112-114.Google Scholar

See Evans, supra note 39, at 2074-80 (discussing the application of HIPAA's individual access right to genomic information stored at HIPAA-covered laboratories); Evans and Wolf, supra note 45 (discussing ethical principles informing the return of genomic test results).Google Scholar

See Evans et al., supra note 55.Google Scholar

Celesti, F. et al., “Why Deep Learning Is Changing the Way to Approach NGS Data Processing: A Review,” IEEE Review in Biomedical Engineering 11 (2018): 68–76; Goldfeder, R. L. et al., “Human Genome Sequencing at the Population Scale: A Primer on High-Throughput DNA Sequencing and Analysis,” American Journal of Epidemiology 186, no. 8 (2017): 1000–1009; Moorthie, S. et al., “Informatics and Clinical Genome Sequencing: Opening the Black Box,” Genetics in Medicine 15, no. 3 (2013): 165–171; see also DHHS, FDA, Transcript of Workshop, Standards Based Approach to Analytical Performance Evaluation of Next Generation Sequencing in Vitro Diagnostic Tests (November 12, 2015), available at <http://wayback.archive-it.org/7993/20170113000252/ http://www.fda.gov/downloads/MedicalDevices/NewsEvents/Workshop-sConferences/UCM478417.pdf> (last visited October 20, 2019), at 228.CrossRefGoogle Scholar

See Evans et al., supra note 55.Google Scholar

Id.Google Scholar

Department of Health & Human Services, Centers for Medicare and Medicare Services, List of Approved Accreditation Organizations under the Clinical Laboratory Improvement Amendments (CLIA), available at <https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/AOList.pdf> (last visited June 4, 2019).+(last+visited+June+4,+2019).>Google Scholar

See International Medical Device Regulators’ Forum, Software as a Medical Device (SaMD): Key Definitions, December 9, 2013, available at <http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-131209-samd-key-definitions-140901.pdf> (last visited October 20, 2019) (distinguishing software in a device from software as a device); see also DHHS, FDA, What are examples of Software as a Medical Device? (last updated December 6, 2017), available at <https://www.fda.gov/medicaldevices/digitalhealth/softwareasamedicaldevice/ucm587924.htm> (last visited October 20, 2019).+(last+visited+October+20,+2019)+(distinguishing+software+in+a+device+from+software+as+a+device);+see+also+DHHS,+FDA,+What+are+examples+of+Software+as+a+Medical+Device?+(last+updated+December+6,+2017),+available+at++(last+visited+October+20,+2019).>Google Scholar

See supra note 70.Google Scholar

See discussion infra this subsection.Google Scholar

See 21st Century Cures Act, Pub. L. No. 114-255, § 3060(a), 130 Stat. 1033 (2016).Google Scholar

See discussion infra this subsection.Google Scholar

See Evans et al., supra note 55.Google Scholar

See Marchant, G. et al., “From Genetics to Genomics: Facing the Liability Implications in Clinical Care,” Journal of Law, Medicine & Ethics 48, no. 4 (2020): 11–43.CrossRefGoogle Scholar

518 U.S. 470 (1996).Google Scholar

552 U.S. 312 (2008).Google Scholar

See Riegel, 552 U.S. at 321-323.Google Scholar

Id.Google Scholar

DHHS, FDA, Digital Health Innovation Action Plan (2017), available at <https://www.fda.gov/downloads/MedicalDe-vices/DigitalHealth/UCM568735.pdf> (last visited October 20, 2019); see also DHHS, FDA, Developing Software Precertification Program: A Working Model v.0.2 (June 18, 2018), available at <https://www.fda.gov/media/113802/download> (last visited October 20, 2019).+(last+visited+October+20,+2019);+see+also+DHHS,+FDA,+Developing+Software+Precertification+Program:+A+Working+Model+v.0.2+(June+18,+2018),+available+at++(last+visited+October+20,+2019).>Google Scholar

See supra note 81.Google Scholar

Id.Google Scholar

The surveyed transcripts of relevant FDA Public Workshops included 2,845 pages of transcriptions of proceedings at the following meetings: DHHS, FDA, supra note 62; DHHS, FDA, supra note 66; DHHS, HHS, Transcripts of Public Workshop - Fostering Digital Health Innovation: Developing the Software Precertification Program (January 30-31, 2018), available at <https://www.fda.gov/media/111883/download> (last visited October 20, 2019) and <https://www.fda.gov/media/111889/download> (last visited October 20, 2019); DHHS, FDA, Transcript of Public Workshop - Weighing the Evidence: Variant Classification and Interpretation in Precision Oncology (January 29, 2018), available at <https://www.fda.gov/media/111496/download> (last visited October 20, 2019); Transcript of Public Workshop - Adapting Regulatory Oversight of Next Generation Sequencing-Based Tests (September 23, 2016), available at <http://wayback.archive-it.org/7993/20171115051312/ https://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM527804.pdf> (last visited October 20, 2019); DHHS, FDA, Transcript of Public Workshop - Patient and Medical Professional Perspectives on the Return of Genetic Test Results, March 2, 2016, available at <http://wayback.archive-it.org/7993/20171115183228/ https://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM499537.pdf> (last visited October 20, 2019); DHHS, FDA, Transcript of Public Workshop - Next Generation Sequencing-Based Oncology Panels, February 25, 2016, available at <http://wayback.archive-it.org/7993/20171115183258/ https://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM497757.pdf> (last visited October 20, 2019); DHHS, FDA, Transcript of Public Workshop - Use of Databases for Establishing the Clinical Relevance of Human Genetic Variants, November 13, 2015, available at <http://wayback.archive-it.org/7993/20170113000246/ http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM478844.pdf> (last visited October 20, 2019); DHHS, FDA, Transcript of Public Workshop-Standards Based Approach to Analytical Performance Evaluation of Next Generation Sequencing In Vitro Diagnostic Tests, November 12, 2015, available at <http://wayback.archive-it.org/7993/20170113000252/ http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM478417.pdf> (last visited October 20, 2019); DHHS, FDA, Transcript of Public Workshop - Optimizing FDA's Regulatory Oversight of Next Generation Sequencing Diagnostic Tests Public Workshop, February 20, 2015, available at <http://wayback.archive-it.org/7993/20170113000324/ http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM439974.pdf> (last visited October 20, 2019); DHHA, FDA, Transcripts of Public Workshop-Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs), January 8-9, 2015, available at <http://way-back.archive-it.org/7993/20170113120101/ http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM431392.pdf> (last visited on October 20, 2019) and <http://wayback.archive-it.org/7993/20170113120104/ http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM431422.pdf> (last visited on October 20, 2019). (last visited October 20, 2019); DHHA, FDA, Transcripts of Public Workshop-Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs), January 8-9, 2015, available at (last visited on October 20, 2019) and (last visited on October 20, 2019).' href=https://scholar.google.com/scholar?q=The+surveyed+transcripts+of+relevant+FDA+Public+Workshops+included+2,845+pages+of+transcriptions+of+proceedings+at+the+following+meetings:+DHHS,+FDA,+supra+note+62;+DHHS,+FDA,+supra+note+66;+DHHS,+HHS,+Transcripts+of+Public+Workshop+-+Fostering+Digital+Health+Innovation:+Developing+the+Software+Precertification+Program+(January+30-31,+2018),+available+at++(last+visited+October+20,+2019)+and++(last+visited+October+20,+2019);+DHHS,+FDA,+Transcript+of+Public+Workshop+-+Weighing+the+Evidence:+Variant+Classification+and+Interpretation+in+Precision+Oncology+(January+29,+2018),+available+at++(last+visited+October+20,+2019);+Transcript+of+Public+Workshop+-+Adapting+Regulatory+Oversight+of+Next+Generation+Sequencing-Based+Tests+(September+23,+2016),+available+at++(last+visited+October+20,+2019);+DHHS,+FDA,+Transcript+of+Public+Workshop+-+Patient+and+Medical+Professional+Perspectives+on+the+Return+of+Genetic+Test+Results,+March+2,+2016,+available+at++(last+visited+October+20,+2019);+DHHS,+FDA,+Transcript+of+Public+Workshop+-+Next+Generation+Sequencing-Based+Oncology+Panels,+February+25,+2016,+available+at++(last+visited+October+20,+2019);+DHHS,+FDA,+Transcript+of+Public+Workshop+-+Use+of+Databases+for+Establishing+the+Clinical+Relevance+of+Human+Genetic+Variants,+November+13,+2015,+available+at++(last+visited+October+20,+2019);+DHHS,+FDA,+Transcript+of+Public+Workshop-Standards+Based+Approach+to+Analytical+Performance+Evaluation+of+Next+Generation+Sequencing+In+Vitro+Diagnostic+Tests,+November+12,+2015,+available+at++(last+visited+October+20,+2019);+DHHS,+FDA,+Transcript+of+Public+Workshop+-+Optimizing+FDA's+Regulatory+Oversight+of+Next+Generation+Sequencing+Diagnostic+Tests+Public+Workshop,+February+20,+2015,+available+at++(last+visited+October+20,+2019);+DHHA,+FDA,+Transcripts+of+Public+Workshop-Framework+for+Regulatory+Oversight+of+Laboratory+Developed+Tests+(LDTs),+January+8-9,+2015,+available+at++(last+visited+on+October+20,+2019)+and++(last+visited+on+October+20,+2019).>Google Scholar

See DHHS, FDA, Clinical and Patient Decision Support Software: Draft Guidance for Industry and Food and Drug Administration Staff, December 8, 2017 (providing FDA's first draft guidance on clinical decision support software, which has been withdrawn).Google Scholar

Id. at 7 (emphasis added).Google Scholar

See DHHS, FDA, Clinical Decision Support Software: Draft Guidance for Industry and Food and Drug Administration Staff, September 27, 2019, available at <https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-decision-support-software> (last visited October 20, 2019) (providing FDA's current draft guidance on clinical decision support software).+(last+visited+October+20,+2019)+(providing+FDA's+current+draft+guidance+on+clinical+decision+support+software).>Google Scholar

Id. at 27.Google Scholar

Id.Google Scholar

See 21 U.S.C. § 321(h) (codifying § 201(h) of the Food, Drug, and Cosmetic Act, which defines the medical devices that Congress has authorized FDA to regulate).Google Scholar

Id. at § 360j(o)(1)(E).Google Scholar

See DHHS, FDA, supra notes 85 and 87.Google Scholar

See 21 U.S.C. § 360j(o)(1)(E).Google Scholar

Id. at 4.Google Scholar

See 21 U.S.C. § 360j(o)(1)(E)(i)-(ii) (describing software for the purpose of “(i) displaying, analyzing, or printing medical information about a patient or other medical information (such as peer-reviewed clinical studies and clinical practice guidelines); (ii) supporting or providing recommendations to a health care professional about prevention, diagnosis, or treatment of a disease or condition”); see also Clinical Decision Support (CDS), HealthIT.gov (last updated January 15, 2013), available at <https://www.healthit.gov/policy-researchers-implementers/clinical-decision-support-cds> and <https://perma.cc/JWV8-YUGQ> (last visited February 26, 2018) (offering another helpful definition).+and++(last+visited+February+26,+2018)+(offering+another+helpful+definition).>Google Scholar

21 U.S.C. § 360j(o)(1)(E).Google Scholar

Thompson, B. M., “Learning from Experience: FDA's Treatment of Machine Learning,” Mobile Health News, August 23, 2017, available at <http://www.mobihealthnews.com/content/learning-experience-fda%E2%80%99s-treatment-machine-learning> and <https://perma.cc/Q95C-9R22> (last visited February 26, 2018). and (last visited February 26, 2018).' href=https://scholar.google.com/scholar?q=Thompson,+B.+M.,+“Learning+from+Experience:+FDA's+Treatment+of+Machine+Learning,”+Mobile+Health+News,+August+23,+2017,+available+at++and++(last+visited+February+26,+2018).>Google Scholar

See generally Price, W. N., “Regulating Black-Box Medicine,” Michigan Law Review 116, no. 3 (2017): 421–474 (discussing black-box software used in medical applications).Google Scholar

21 U.S.C. § 360j(o)(1)(E)(iii).Google Scholar

DHHS, FDA supra note 87, at 27.Google Scholar

Id.Google Scholar

21 U.S.C. § 360j(o)(1)(E)(iii).Google Scholar

DHHS, FDA, supra note 87, at 27.Google Scholar

DHHS, FDA, Genetic Database Recognition Decision Summary for ClinGen Expert Curated Human Variant Data, available at <https://www.fda.gov/media/119313/download> (last visited October 25, 2019).+(last+visited+October+25,+2019).>Google Scholar

21 U.S.C. § 360j(o)(1)(E)(iii). See discussion supra notes 96-99 and accompanying text.Google Scholar

DHHS, FDA, supra note 87, at 18–20.Google Scholar

Id. at 27.Google Scholar

Id.Google Scholar

See supra notes 24–28 and accompanying text.Google Scholar

21 U.S.C. § 360j(o)(1)(E).Google Scholar

21 U.S.C. § 360j(o)(1)(E)(i)-(ii).Google Scholar