Structural Challenges of Precision Medicine

See E. Juengst , “From ‘Personalized’ to ‘Precision’ Medicine: The Ethical and Social Implications of Rhetorical Reform in Genomic Medicine,” Hastings Center Report 46, no. 5 (2016): 21-33.

National Institutes of Health, “Precision Medicine Initiative,” available at <https://www.nih.gov/precision-medicine-initiative-cohort-program> (last visited June 5, 2017); F.S. Collins and H. Varmus, “A New Initiative on Precision Medicine,” New England Journal of Medicine 372, no. 9 (2015): 793-795.

45 C.F.R. § 164.524.

42 C.F.R. Pt. 493.

See, e.g., K. J. Hofman et al ., “Physicians' Knowledge of Genetics and Genetic Tests,” Academic Medicine 68, no. 8 (1993): 625-632; V. C. Thurston et al., “The Current Status of Medical Genetics Instruction in US and Canadian Medical Schools,” Academic Medicine 82, no. 5 (2007): 441-445.

D. C. Dougdale , R. E. Epstein , and S. Z. Pantilat , “Time and the Patient-Physician Relationship,” Journal of General Internal Medicine 14, no. Supp. 1 (1999): S30-S40; M. Linzer, “Managed Care, Time Pressure, and Physician Job Satisfaction: Results from the Physician Worklife Study,” Journal of General Internal Medicine 15, no. 7 (2000): 441-450.

See Babbott et al ., “Electronic Medical Records and Physician Stress in Primary Care: Results from the MEMO Study,” Journal of the American Medical Informatics Association 21, no. e1 (2014): e100-e106.

See AMA Code of Medical Ethics § 8.082 (noting repeal of the therapeutic privilege in 2006).

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; M. A. Rothstein, “Some Lingering Concerns about the Precision Medicine Initiative,” Journal of Law, Medicine & Ethics 44, no. 3 (2016): 520-525.

L. Tieu et al ., “Online Patient Web-sites for Electronic Health Record Access among Vulnerable Populations: Portals to Nowhere?” Journal of the American Medical Informatics Association (2016): e47-454; L. S. Wallace et al., “Patterns of Electronic Portal Use among Vulnerable Patients in a Nationwide Practice-Based Research Network: From the OCHIN Practice-based Research Network (PBRN),” Journal of the American Board of Family Medicine 29, no. 5 (2016): 592-603.

R. F. Chadwick et al ., The Right to Know and the Right Not to Know: Genetic Privacy and Responsibility, 2nd ed. (Cambridge, U.K.; Cambridge University Press, 2014); R. Andorno, “The Right Not to Know: An Autonomy Based Approach,” Journal of Medical Ethics 30, no. 5 (2004): 435-439; G. Helgesson, “Autonomy, the Right Not to Know, and the Right to Know Personal Health Research: What Rights Are There and Who Should Decide about Exceptions?” Journal of Law, Medicine & Ethics 42, no. 1 (2014): 28-37.

K. G. Baron et al ., “Orthosomnia: Are Some Patients Taking the Quantified Self Too Far?” Journal of Clinical Sleep Medicine 13, no. 2 (2017): 351-354.

See P. Glaszious et al ., “Too Much Medicine; Too Little Care,” British Medical Journal 347, no. f4247 (2013), available at <http://www.bmj.com/content/347/bmj.f4247> (last visited June 5, 2017); S. Timmerman and M. Buchbinder, “Patients-in-Waiting: Living between Sickness and Health in the Genomic Era,” Journal of Health and Social Behavior 51, no. 4 (2010): 408-423.

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

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 61-62, available at <http://acd.od.nih.gov/reports/DRAFT-PMI-WG-Report-9-11-2015-508.pdf> (last visited June 5, 2017).

See, e.g., J. A. Bovenberg et al ., “Don't Take It Personal: European Union Legal Aspects of Procuring and Protecting Environmental Exposure Data in Population Biobanks through the Use of a Geo-Information-Systems Toolkit,” Biopreservation & Biobanking 14, no. 3 (2016): 217-223.

M. A. Rothstein and M. K. Talbott , “Compelled Disclosures of Health Records: Updated Estimates,” Journal of Law, Medicine & Ethics 45, no. 1 (2017): 149-155.

M. A. Rothstein and L. Rothstein , “How Genetics Might Affect Real Property Rights,” Journal of Law, Medicine & Ethics 44, no. 1 (2016): 216-220.

M. A. Rothstein , “The End of the HIPAA Privacy Rule?” Journal of Law, Medicine & Ethics 44, no. 2 (2016): 352-358.

L. J. Kish and E. J. Topol , “Unpatients–Why Patients Should Own Their Own Medical Data,” Nature Biotechnology 33, no. 9 (2015): 921-924.

B. J. Evans , “Barbarians at the Gate: Consumer-Driven Health Data Commons and the Transformation of Citizen Science,” American Journal of Law and Medicine 42, no. 4 (2016): 651-685.

C. E. Reeder and W. M. Dickson , “Economic Implications of Pharmacogenomics,” in M. A. Rothstein , ed., Pharmacogenomics: Social, Ethical, and Clinical Dimensions (Hoboken, NJ; Wiley-Liss, 2003): 229-250.

A. D. Stern , B. M. Alexander , and A. Chandra , “How Economics Can Shape Precision Medicines,” Science 355, no. 6330 (2017): 1131-1133.

See M. A. Rothstein , “Epilogue: Policy Prescriptions,” in Pharmacogenomics: Social, Ethical, and Clinical Dimensions, supra note 22, at 319-335.

V. L. Bonham , S. L. Callier , and C. D. Royal , “Will Precision Medicine Move Us beyond Race?” New England Journal of Medicine 374, no. 21 (2016): 2003-2005.

A. Tanner , Our Bodies, Our Data: How Companies Make Billions Selling Our Medical Records (Boston: Beacon Press, 2017).

See M. C. Adams et al ., “The Promise and Peril of Genomic Sequencing in the General Population,” Genetics in Medicine 18, no. 6 (2016): 593-599 (reporting high rates of false positive results for conditions with very low prevalence); M. A. Rothstein, “The Case against Precipitous, Population-Wide, Whole-Genome Sequencing,” Journal of Law, Medicine & Ethics 40, no. 3 (2012): 682-689 (noting that clinical genome sequencing currently benefits mostly cancer patients and those with rare disorders).

See C. E. Smith et al ., “Using Genetic Technologies to Reduce, Rather than Widen, Health Disparities,” Health Affairs 35, no. 8 (2016): 1367-1373.

See, e.g., T. Caulfield et al ., “Reflections on the Cost of ‘Low Cost’ Whole Genome Sequencing: Framing the Health Policy Debate,” PLOS Biology 11 (2013): e1001699; I. S. Kohane, “Ten Things We Need to Do to Achieve Precision Medicine,” Science 349, no. 6243 (2016): 37-38.