Health care has become slightly more connected, less regulated and open to innovation. The FDA announced on Friday that it intends to reduce the regulatory burden for medical device data systems (MDDS) that use hardware and software to transfer, store, convert format and display medical device data without controlling or altering the functionality of connected medical devices. (http://blogs.fda.gov/fdavoice/index.php/2014/06/fda-encourages-medical-device-data-system-innovation/). While we encourage the FDA to revise the underlying regulation, this announcement of “enforcement discretion” is a good first step. We hope that it will enable device makers to more quickly satisfy the perfectly reasonable request of patients, like Anna McCollister-Slipp, who use multiple devices to manage chronic disease but cannot gather all the data in a single location for management and analysis.
As to the effect of this announcement on industry, it will make it easier for the largest purveyors of connected solutions, devices and networks to enter the connected health field. Qualcomm, AT&T and Verizon are already involved and recent announcements and activities by Apple, Google and Samsung demonstrate their interest. This is good for consumers. Just as ambulances use public highways, the FDA action acknowledges that consumer technologies offer the best “road” for medical data.
Does this mean that these services quickly become commoditized? I do not think so. While they can quickly incorporate the newest or cheapest components, connected health care services will succeed based on their value to patients and financial sponsors. Value is based on cost and health outcomes. The winners will be organizations that assemble and operate in a manner that embraces the new transparency of cost and outcomes that is overtaking health care. These organizations will comfortably operate in both the regulated health care space and the consumer world.
Much more news on related issues will be coming later this year. THE FDASIA Report from the FDA, FCC and ONC is available for comment with respect to its plan for the regulation of “health IT.” FDA is also developing formal guidance on several key topics for connected health, including clinical decision support software (CDS), the regulation of “accessories” to medical devices and the line between unregulated personal wellness devices and regulated medical devices. WLSA will be commenting and proposing a new approach to regulation of these areas which is based on easing the pre-market regulatory burden and leveraging the power of connectivity and big data to increase transparency regarding the safety and efficacy of devices and drugs in the market.