Some Lingering Concerns about the Precision Medicine Initiative

National Institutes of Health, “Precision Medicine Initiative,” available at <https://www.nih.gov/precision-medicine-initiative-cohort-program> (last visited July 21, 2016).

F. S. Collins and H. Varmus , “A New Initiative on Precision Medicine,” New England Journal of Medicine 372, no. 9 (2015): 793–795.

White House, “Precision Medicine Initiative,” available at <https://www.whitehouse.gov/precision-medicine> (last visited July 21, 2016).

H. Aschard et al. , “Inclusion of Gene-Gene and Gene-Environment Interactions Unlikely to Dramatically Improve Risk Predictions for Complex Diseases,” American Journal of Human Genetics 90, no. 6 (2012): 962-972; J. Buchanan, S. Wordsworth, and A. Schuh, “Issues Surrounding the Health Economic Evaluation of Genomic Technologies,” Pharmacogenomics 14, no. 15 (2013): 1833-1847; M. V. Relling and W. E. Evans, “Pharmacogenomics in the Clinic,” Nature 526, no. 7573 (2015): 343-350; N. J. Roberts, “The Predictive Capacity of Personal Genome Sequencing,” Science Translational Medicine, available at <http://stm.sciencemag.org/content/early/2012/04/02/scitranslmed.3003380.full.pdf> (last visited July 21, 2016).

See NIH, supra note 1.

For a discussion of other issues, including regulatory issues, see D. Nicol et al. , “Precision Medicine: Drowning in a Regulatory Soup?” Journal of Law and the Biosciences (2016): 1–23.

Office of the Assistant Secretary of Planning and Evaluation, Department of Health & Human Services, Analysis of the Gallup-Healthways Well-being Index Data through Feb. 22, 2016, available at <https://aspe.hhs.gov/sites/default/files/pdf/187551/ACA2010-2016.pdf> (last visited July 21, 2016).

L. Cooper , “Even with Obamacare, 29 Million People Are Uninsured: Here's Why,” The Fiscal Times, May 10, 2016, available at <http://www.thefiscal-times.com/2016/05/10/Even-Obamacare-29-Million-People-Are-Uninsured-Here-s-Why> (last visited July 21, 2016).

U.S. Department of Health and Human Services, “Projecting the Supply and Demand for Primary Care Practitioners through 2020” (2013); T. Dall et al., “The Complexities of Physician Supply and Demand: Projections from 2013 to 2025,” Association of American Medical Colleges (2015), available at <https://www.aamc.org/download/153160/data/physician_shortages_to_worsen_without_increases_in_residency_tr.pdf> (last visited July 21, 2016).

K. B. Brothers and M. A. Rothstein , “Ethical, Legal and Social Implications of Incorporating Personalized Medicine into Healthcare,” Personalized Medicine 12, no. 1 (2015): 43-51, at 47.

See Relling and Evans, supra note 4, at 347.

Precision Medicine Initiative (PMI) Working Group Report to the Advisory Committee to the Director, NIH, The Precision Medicine Initiative Cohort Program – Building a Research Foundation for 21st Century Medicine (September 17, 2015): at 85, available at <http://acd.od.nih.gov/reports/DRAFT-PMIWG-Report-9-11-2015-508.pdf> (last visited August 16, 2016).

Id., at 2; White House, Precision Medicine Initiative: Privacy and Trust Principles (November 9, 2015).

See PMI Working Group Report, supra note 14, at 15–18.

See NIH, supra note 1.

Id. See generally, E. Topol , The Patient Will See You Now (New York: Basic Books, 2015).

C. M. R. Smerecnik et al. , “Educating the General Public about Multifactorial Genetic Disease: Applying a Theory-Based Framework to Understand Current Public Knowledge,” Genetics in Medicine 10, no. 4 (2008): 251–258.

Committee on Health Literacy, Institute of Medicine, Health Literacy: A Prescription to End Confusion (Washington: National Academy Press, 2004); National Center for Educational Statistics, U.S. Department of Education, The Health Literacy of America's Adults: Results from the 2003 National Assessment of Adult Literacy (Washington: National Academy Press, 2006).

R. L. Klitzman , “Misunderstandings Concerning Genetics among Patients Confronting Genetic Disease,” Journal of Genetic Counseling 19, no. 5 (2010): 430-446; A. D. Lanie et al., “Exploring the Public Understanding of Basic Genetic Concepts,” Journal of Genetic Counseling 13, no. 4 (2004): 305–320.

Slightly more than 1,500 physicians have been certified by the American Board of Medical Genetics and Genomics since its first examination in 1982, and it is unknown how many of these individuals are still practicing. David Flannery, Medical Director of the American College of Medical Genetics and Genomics (personal communication, June 30, 2016).

From 1982-2016, “over 4,000” genetic counselors received certification, and it is not known how many are still practicing. American Board of Genetic Counselors, Inc., Certification, available at <http://www.abgc.net/Certification/certification.asp> (last visited July 21, 2016). See also M. I. Roche and A. E. Greb , “It's Time to Ramp Up Genetic Counseling Training,” Genetics in Medicine (forthcoming 2016).

S. Raghavan and J. L. Vassy , “Do Physicians Think Genomic Medicine Will Be Useful for Patient Care?” Personalized Medicine 11, no. 4 (2014): 425–433.

M. L. McGowan et al. , “Gatekeepers or Intermediaries? The Role of Clinicians in Commercial Genomic Testing,” PLoS One 9, no. 9 (2014): 1-7; C. Graber, “The Problem with Precision Medicine,” New Yorker, February 5, 2015, available at <http://www.newyorker.com/tech/elements/problem-precision-medicine> (last visited July 21, 2016). See also S. L. Van Driest et al., “Association of Arrhythmia-Related Genetic Variants with Phenotypes Documented in Electronic Medical Records,” Journal of the American Medical Association 315, no. 1 (2016): 47-57 (finding significant lack of concordance among laboratories).

W. C. Birmingham et al. , “Patient and Provider Attitudes Toward Genomic Testing for Prostate Cancer Susceptibility: A Mixed Method Study,” BMC 524 journal of law, medicine & ethics Mark A. Rothstein Health Services Research 13, no. 1 (2013): 1–12.

R. Sukenik-Halevy et al. , “The Time-Consuming Demands of the Practice of Medical Genetics in the Era of Advanced Genomic Testing,” Genetics in Medicine 18, no. 4 (2016): 372-377, at 376.

Id., at 374.

See PMI Working Group Report, supra note 14, at 4.

Id., at 65.

See M. A. Rothstein , B. M. Knoppers , and H. L. Harrell , “Comparative Approaches to Biobanks and Privacy,” Journal of Law, Medicine & Ethics 44, no. 1 (2016): 161–172.

M. A. Rothstein , “Research Privacy under HIPAA and the Common Rule,” Journal of Law, Medicine & Ethics 33, no. 1 (2005): 154–159.

Department of Health and Human Services, “Omnibus Amendments to the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, Enforcement, and Breach Notification Rules,” 78 Federal Register 5566-5702, 5613 (January 25, 2013). Future uses of health records include both prospective uses of extant health records and future updates of existing health records.

The “minimum necessary” provision of the HIPAA Privacy Rule states: “When using or disclosing protected health information or when requesting protected health information from another covered entity or business associate, a covered entity or business associate must make reasonable efforts to limit protected health information to the minimum necessary to accomplish the intended purpose of the use, disclosure, or request.” 45 C.F.R. § 164.502(b)(1). This provision applies to disclosures of protected health information for payment and health care operations, but not for treatment. See J. L. Agris , “Extending the Minimum Necessary Standard to Uses and Disclosures for Treatment,” Journal of Law, Medicine & Ethics 43, no. 1 (2014): 263-267; M. A. Rothstein, “The End of the HIPAA Privacy Rule?” Journal of Law, Medicine & Ethics 44, no. 2 (2016): 352–358.

See PMI Working Group Report, supra note 14, at 66.

M. A. Rothstein and M. K. Talbott , “Compelled Authorizations for Disclosure of Health Records: Magnitude and Implications,” American Journal of Bio-ethics 7, no. 3 (2007): 38-45, at 40.

See H. L. Harrell and M. A. Rothstein , “Biobanking Research and Privacy Laws in the United States,” Journal of Law, Medicine & Ethics 44, no. 1 (2016): 106-127.

42 U.S.C. § 2000ff.

See M. A. Rothstein , “Putting the Genetic Information Nondiscrimination Act in Context,” Genetics in Medicine 10, no. 9 (2008): 655–656.

Gattaca, directed by A. Niccol, Columbia Pictures, 1997.

See M. A. Rothstein , “Ethical Issues in Big Data Health Research,” Journal of Law, Medicine & Ethics 43, no. 2 (2015): 425–429.

PMI Working Group Report, supra note 14, at 61–62.

T. Fischer et al. , “Clinical Decision-Making and Secondary Findings in Systems Medicine,” BMC Medical Ethics 17, no. 1 (2016): 32, available at <http://www.ncbi.nlm.nih.gov/pubmed/27209083> (last visited July 21, 2016). See also F. Pasquale, The Black Box Society: The Secret Algorithms that Control Money and Information (Cambridge, MA: Harvard University Press, 2015).