Congress May Act if Healthcare App Industry Fails to Address Privacy, Security, Burgess Says

House Commerce Trade Subcommittee Chairman Michael Burgess, R-Texas, warned witnesses Wednesday that Congress would act on healthcare apps if industry doesn't appropriately address privacy and security. “Unfortunately, whatever Congress would do would likely limit the potential in this space and limit the success of the health apps market,” Burgess said during a subcommittee hearing on such apps. Commerce Committee Chairman Fred Upton, R-Mich., said “the right regulatory framework” is required, one “that encourages innovation, removes barriers to investment, and advances new opportunities for patients and providers to engage in the healthcare system,” with privacy and security “absolute musts.” Commerce Committee ranking member Frank Pallone, D-N.J., raised concerns about hacking and consumer and stakeholder confusion. “Many, if not most, health apps available right now in the app store are not covered entities" under the Health Insurance Portability and Accountability Act, Pallone said. “So even if those apps collect the same information as a healthcare provider, the same protections may not apply.” Lawmakers and witnesses debated the appropriate roles for the FTC and the Food and Drug Administration. With a seat on "the Consumer Technology Association’s (CTA) Health and Fitness Technology Board, Humetrix actively worked on the CTA Guiding Principles on the Privacy and Security of Personal Wellness Data because it is important that consumers understand both the potential value of health technologies and the privacy options they have,” testified Humetrix CEO Bettina Experton. “We applaud CTA’s efforts to drive these guiding principles across the industry, as we believe it will drive adoption and awareness of important medical apps that can literally save lives.” Diane Johnson, senior director at Johnson & Johnson, told Rep. Leonard Lance, R-N.J., “legislative clarity is needed” on the FDA mobile medical app guidance regarding enforcement. Commerce Committee Vice Chairwoman Marsha Blackburn, R-Tenn., underscored her desire to advance her Sensible Oversight for Technology which Advances Regulatory Efficiency Act (HR-2396) through the 21st Century Cures initiative. She said her legislation addresses much of what was under discussion.