It has been a busy policy month for connected health. 2015 may see a convergence of forces activities that create an inflection in the market. Last week, the FDA approved Dexcom Share for direct transmission of BG readings to a smartphone and did so 120 days after submission. The FDA has accelerated the pace of action on connected health devices and published guidance on accessories and wellness in early January, as well as a commitment to publish guidance on clinical decision support this year.
Earlier this week, HHS announced specific targets for shifting Medicare payment from “volume to value” and the private sector piled on with even more aggressive targets. The alignment of payment formulas with the goals of quality and efficiency have been missing ingredients in connected health so these changes are important.
Finally, the FTC has issued a report and recommendations on the privacy and security implications of the “Internet of Things,” including connected health platforms. There will be lots of coverage for this report, including MHN. One of the Commissioners dissented to the report as being premature. On the positive side, the report helps to alert the connected health community to important issues. Problematically, finding the right balance between forward regulation and fixing problems as they become more defined is difficult. As with WLSA’s cautionary note to the FCC on net neutrality, we recommend that we balance the need for vast improvement in the quality, affordability and accessibility of health care against the agency’s concerns. The need for health trumps privacy in most circumstances. WLSA believes we can strike the right balance.