Autonomy and Paternalism in Health Policy: Currents in Contemporary Bioethics

See generally Rothman D. J. , Strangers at the Bedside: A History of How Law and Ethics Transformed Medical Decision Making (BasicBooks, 1977).

Starr P. , The Social Transformation of American Medicine (1982).

Katz J. , The Silent World of Doctor and Patient (The Free Press, 1986).

Id., at 71–84.

The therapeutic privilege permitted physicians to withhold information from patients if, in their clinical judgment, disclosure would be harmful to the patient “medically contraindicated”). In 2006, the American Medical Association declared that withholding information from patients was ethically unacceptable. American Medical Association, Code of Medical Ethics (2012–2013 edition) § 8.082 – Withholding Information from Patients (2012).

See, e.g., Epstein R. M. Street R. L. Jr. , “The Values and Value of Patient-Centered Care,” Annals of Family Medicine 9, no. 2(2011): 100–103.

“Symposium – Patient-Centered Law and Ethics,” Wake Forest Law Review 45, no. 5: 1429–1564(2010).

Pew Research Internet Project, Health Online 2013, available at <www.pewinternet.org/2013/01/15/health-on-line-2013>(last visited April 23, 2014).

Ginsburg J. , “Detecting Influenza Epidemics Using Search Engine Query Data,” Nature 457, no. 7232(2009): 1012–1014. A follow-up paper concluded that the Google researchers estimated almost twice as many flu cases as the CDC.

Butler D. , “When Google Got Flu Wrong,” Nature 494, no. 7436(2013): 155–156.

See, e.g., <www.patientslikeme.com>(last visited December 5, 2014).

Frist W. H. , “Connected Health and the Rise of the Patient-Consumer,” Health Affairs 33, no. 2(2014): 191–193.

Food and Drug Administration, Mobile Medical Applications, October 2013, available at <http://www.fda.gov/medicaldevices/productsandmedicalprocedures/connectedhealth/mobilemedicalapplications/default.htm>(last visited December 5, 2014).

42 U.S.C. § 300gg-4(j)(3)(A) (2012).

Implementing regulations appear at 26 C.F.R. § 54.9802–1(f)(2)(i) (2014).

29 C.F.R. § 2590.702(f)(2)(i) (2013).

45 C.F.R. § 146.121(f)(2)(i) (2013).

“Minimum essential coverage” for health insurance is required by section 1501(b) of the Patient Protection and Affordable Care Act, 26 U.S.C. § 5000A(f) (2012).

The Patient Protection and Affordable Care Act prohibits health plans that fail to contain essential elements. Patient Protection and Affordable Care Act § 1302, 42 U.S.C. § 18022.

Health Information Technology for Economic and Clinical Health Act (HITECH Act) § 13400(5), 42 U.S.C. § 300jj(13).

Health Information Technology for Economic and Clinical Health Act (HITECH Act) § 13400(11), 42 U.S.C. § 17921(5).

National Committee on Vital and Health Statistics, Letter to Levitt Michael O. , Secretary of Health and Human Services, September 9, 2005, available at <http://www.ncvhs.hhs.gov/050909>(last visited December 5, 2014).

see also Department of Health and Human Services, Office for Civil Rights, “Personal Health Records and the HIPAA Privacy Rule,” (undated), available at <www.hhs.gov/ocr/privacy/hipaa/understanding/special/healthit/phrs.pdf>(last visited December 5, 2014).

See, e.g., National Committee on Vital and Statistics Health “Information for Health: A Strategy for Building the National Health Information Infrastructure” (2001), available at <http://www.ncvhs.hhs.gov/nhiilayo.pdf>(last visited December 5, 2014).

Turley M. , “Association Between Personal Health Record Enrollment and Patient Loyalty,” American Journal of Managed Care 18, no. 7(2012): e248-e–253.

42 U.S.C. §§ 1302, 1395hh.

The meaningful use criteria are codified at 45 C.F.R. Part 170. See generally Terry N. P. , “Meaningful Adoption: What We Know or Think We Know about the Financing, Effectiveness, Quality, and Safety of Electronic Medical Records,” Journal of Legal Medicine 34, no. 1(2013): 7–42.

Federal Register 79 (February 6, 2014): 7290.

42 C.F.R. § 493.1291(f) (2013).

45 C.F.R. § 164.524(a)(1)(iii) (2013).

The amended regulation preempts state laws prohibiting the release of a laboratory report to the individual. Federal Register 79 (2014): 7290, 7292.

Federal Register 79 (2014): 7290, 7293.

See Federal Register 76 (2011): 56712, 56720.

Su P. , “Direct-to-Consumer Genetic Testing: A Comprehensive View,” Yale Journal of Biology and Medicine 88, no. 2(2013): 359–365, 361.

Food and Drug Administration, Statement of Jeffrey Shuren. Director for the Center of Devices and Radiological Health before the Subcommittee on Oversight and Investigations, July 22, 2010, available at <http://www.fda.gov/newsevents/testimony/ucm219925.htm>(last visited December 5, 2014).

see also Pollack Andrew , “FDA Faults Companies on Unapproved Genetic Tests,” New York Times, June 11, 2010, <http://www.nytimes.com/2010/06/12/health/12genome.html?_r=0>(last visited December 5, 2014).

See, e.g., Steenhuysen J. , “Consumer Gene Test Results Misleading: U.S. Probe,” Reuters, July 22, 2010, available at <http://www.reuters.com/article/2010/07/22/us-gene-tests-hearing-idUSTRE66L5QF20100722>(last visited December 5, 2014) (explaining that the company Pathway Genomics stopped selling its genetic tests directly to consumers since direct-to-consumer genetic testing came under scrutiny from the FDA).

Food and Drug Administration, Paving the Way for Personalized Medicine: FDA's Role in a New Era of Medical Product Development, October 2013, available at <http://www.fda.gov/downloads/scienceresearch/specialtopics/personalizedmedicine/ucm37242.pdf>(last visited December 5, 2014).

Annas G. J. Elias S. , “23andMe and the FDA,” New England Journal of Medicine 370, no. 11(2014): 985–988, 986.

See Lederer A. , “Toward a Healthier City: Nutrition Standards for New York City Government,” American Journal of Preventive Medicine 46, no. 4(2014): 423–428 (discussing procedures used to develop various proposals to improve nutrition in New York City).

N.Y. City Health Code § 81.53. For more information on the adoption of the amendment implementing the Portion Cap Rule, see the Notice of an Adoption of an Amendment, available at <http://www.nyc.gov/html/doh/downloads/pdf/notice/2012/notice-adoption-amend-article81.pdf>.

N.Y. Statewide Coal. of Hispanic Chambers of Commerce v. New York City Dep't of Health & Mental Hygiene, No. 653584/12, 2013 WL 1343607, at *8 (N.Y. App. Div., March 11, 2013).

Id.

See Shelley D. , “Same Strategy Different Industry: Corporate Influence on Public Policy,” American Journal of Public Health 104, no. 4(2014): e9–e11 (comparing soft drink and restaurant industry response to the rule with the strategies of the tobacco industry).

See, e.g., DeMaria A. N. , “The Nanny State and ‘Coercive Paternalism,’” Journal of the American College of Cardiology 61, no. 20(2013): 2108–2109 (editorial of cardiology journal editor decrying paternalism).

New York State Coalition of Hispanic Chambers of Commerce v. New York City Dep't of Health & Mental Hygiene, 970 N.Y.S.2d 200 (App. Div. 2013).

In re N.Y. Statewide Coal. of Hispanic Chambers of Commerce v. New York City Dep't of Health & Mental Hygiene, 2014 LEXIS 1442 (N.Y., June 26, 2014).

See Gostin L. O. , “Bloomberg's Health Legacy: Urban Innovator or Meddling Nanny,” Hastings Center Report 43, no. 5(2013): 19–25 (asserting that aggressive public health measures are justified).

See Kerkhoff A. H. M. , “Origin of Modern Public Health and Preventive Medicine,” in Doxiadis S. , ed., Ethical Dilemmas in Health Promotion (New York: John Wiley & Sons, 1987) (stating that public health is based on paternalism).

Jacobson v. Massachusetts, 197 U.S. 11,. 25–26 (1905).

See Gostin , supra note 39.

Jacobson P. D. Parmet W. E. , “Defending Public Health Regulations: The Message Is the Medium,” Hastings Center Report 44, no. 1(2014): 4–6, at 5.