address the risks posed by these technologies. 14 Some commentators have urged the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) to provide more meaningful oversight to ensure that mobile health technologies are safe and effective, 15 while others have cautioned that regulatory overreach may stifle innovation. 16 This article focuses on another means for ensuring that mobile health technologies are developed and used in a safe, effective, and data-protective manner: indirect regulation through liability models applied to healthcare professionals, healthcare institutions, and app developers. The areas of malpractice, product liability, and privacy liability remain primarily case law driven, but at this stage in the development of mobile health, there is little case law directly on point. We extrapolate from cases addressing analogous issues to assess potential liability concerns for health care providers who: ( 1) participate in the design of mobile health products; 17 ( 2) use—or decline to use—mobile health products for patient care; and ( 3) recommend or even prescribe the use of mobile health products by patients. 18 We further suggest that the advent of mobile health technologies does not necessitate the development of novel legal doctrines. Rather, existing doctrines are adequate to apply tort and privacy law to the development, use, recommendation, and prescription of mobile health products by healthcare professionals. 19 Like any other new medical technology, mobile health products are likely to amplify existing uncertainties in the tort liability context, at least in the short term. 20 In particular, the standard of care for professional malpractice— which is based on the customary or prevailing practices of the professional
14. See Cortez, supra note 13, at 1201 (“[C]ongress and the FDA have prioritized which devices deserve more regulatory attention based on the risks they present.”); see also 21 C.F.R. § 860.7 (2008) (ruling that the FDA will review evidence concerning the safety and effectiveness of a medical device). 15. Cortez, supra note 13, at 1230; Stephen McInerney, Can You Diagnose Me Now? A Proposal to Modify FDA’s Regulation of Smartphone Mobile Health Applications with a Pre- Market Notification and Application Database System, 70 FOOD & DRUG L.J. 161, 179 (2015). 16. Brady Donnelly, While Healthcare Apps Are on the Rise, the FDA Threatens to Stifle Innovation in the U.S., TNW NEWS (June 9, 2012, 1: 20 PM), http://thenextweb.com/insider/ 2012/06/09/while-healthcare-apps-are-on-the-rise-the-fda-threatens-to-stifle-innovation-in- the-u-s/#gref. 17. See Beth S. Rose, Uncharted Territory: Mobile Medical Apps and Product Liability Collide, N.J. L.J. (Dec. 9, 2015), http://www.njlawjournal.com/id=1202744463977/ Uncharted-Territory-Mobile-Medical-Apps-and-Product-Liability-Collide (noting that liability regarding mobile health will likely “turn on the performance or design of the app itself”). 18. Pam Baker, Mobile Health Apps, Part 4: Life, Death and Lawsuits, TECH NEWS WORLD (May 5, 2011, 5:00 AM), http://www.technewsworld.com/story/72394.html. 19. Rose, supra note 17. 20. Baker, supra note 18.