Upstream Health Law

Arrow K. J. , “Uncertainty and the Welfare Economics of Medical Care,” American Economic Review 53, no. 5(1963): 941–973, at 941.

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): 301–334, 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”).

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.”).

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).

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.”

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.

Christensen C. W. , The Innovator's Dilemma (Boston: Harvard Business Review Press, 1997).

D'Onfro J. , “There's a New App That will Let You Have a Real Doctor's Appointment Using Video Chat on Your Smartphone,” Business Insider, December 1, 2013, available at <http://www.businessinsider.com/doctors-on-demand-medical-app-2013-12?op=1>(last visited December 2, 2014).

Nundy S. , “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.

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).

Frist W. H. , “Connected Health and the Rise of the Patient-Consumer,” Health Affairs 33, no. 2(2014): 191–193, at 192.

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).

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).

Ravindranath M. , “WellDoc Releases Prescription-Only Smartphone App,” Washington Post, 2013, available at <http://www.washingtonpost.com/business/capitalbusiness/welldoc-to-release-prescription-only-smartphone-app/2013/06/21/bf76a794–d826–11e2–9df4–895344c13c30_story.html>(last visited December 2, 2014).

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.

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).

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).

Wellframe, available at <http://www.wellfra.me/>(last visited December 2, 2014).

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).

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).

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).

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).

Petterson S. , “Projecting US Primary Care Physician Workforce Needs: 2010–2025,” Annals of Family Medicine 10, no. 6(2012): 503–509, at 503.

See Sage W. , “The Wal-Martization of Health Care,” Journal of Legal Medicine 28, no. 4(2007): 503–519.

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.

Sage W. , “Out of the Box: The Future of Retail Medical Clinics,” Harvard Law & Policy Review Online 3, no. 1(2009): 1–11, available at <http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2377485>(last visited November 7, 2014).

Spetz J. , “Scope-Of-Practice Laws for Nurse Practitioners Limit Cost Savings That Can Be Achieved in Retail Clinics,” Health Affairs 32, no. 11(2013):., at1977.

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.

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.

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).

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.

Id., at 6.

Haugland D. L. Hughes P. J. , “Retail Health Care Clinics: Filling a Gap in the Health Care System,” in Mason D. J. , eds., Policy and Politics in Nursing and Health Care, 6th ed. (St. Louis: Elsevier, 2014): 252–259, at 256.

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).

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).

Institute of Medicine, The Future of Nursing: Leading Change, Advancing Health (Washington, D.C.: National Academies Press, 2011): At 9.

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).

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).

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.

Federal Communications Commission, National Broadband Plan 206 (2010).

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).

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).

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.

Kellerman A. L. , “Primary Care Technicians: A Solution to the Primary Care Workforce Gap,” Health Affairs 32, no. 11(2013): 1893–1898, at 1894.

Rosenthal E. L. , “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.

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).

See CDC, supra note 45.

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).

Sensible Oversight for Technology Which Advances Regulatory Efficiency (SOFTWARE) Act, H.R. 3303, 113th Cong., 1st Sess. (introduced Oct. 22, 2013).

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).

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 13–18, 20–22.

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).

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).

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).

“Over-The-Counter Drug Monograph System–Past, Present, and Future,” Federal Register 79 (February 24, 2014): 10168, 10170.

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.

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.

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.

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.

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.

Id. (Hoffman and Rowthorn), at 36.

Cal. Bus. & Prof. Code § 2290.5(b) (2011).

Casey v. 23andMe, Inc., Case No. 13CV2847H (S.D. Cal., filed Nov. 27, 2013).

Adler-Milstein J. , “Telehealth among US Hospitals: Several Factors, Including State Reimbursement and Licensure Policies, Influence Adoption,” Health Affairs 33, no. 2(2014): 207–215, at 213.

Ravindranath M. , “WellDoc Releases Prescription-Only Smartphone App,” Washington Post, June 23, 2013, available at <http://www.washingtonpost.com/business/capitalbusiness/welldoc-to-release-prescription-only-smartphone-app/2013/06/21/bf76a794–d826–11e2–9df4–895344c13c30_story.html>(last visited December 2, 2014).

Dolan B. , “WellDoc's BlueStar Secures First Mobile Health Reimbursement,” MobilHealthNews, June 13, 2013, available at <http://mobihealthnews.com/23026/welldocs-bluestar-secures-first-mobile-health-reimbursement/>(last visited December 2, 2014).

Shields M. C. , “A Model for Integrating Independent Physicians into Accountable Care Organizations,” Health Affairs 30, no. 1(2011): 161–172, at 161.

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).

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).

45 C.F.R. § 160.102, 160.103 (2012).

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.

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.

Sage W. M. , “Getting the Product Right: How Competition Policy Can Improve Health Care Markets,” Health Affairs 33, no. 6(2014): 1076–1082.

Gourevitch M. N. , “Population Health and the Academic Medical Center: The Time Is Right,” Academic Medicine 89, no. 4(2014): 544–549, at 544.