Technology companies are spending millions of dollars lobbying the FDA for laws that outline mobile health regulations.
- When you think about lobbyists on Capitol Hill, someone speaking up on behalf of healthcare technology is probably not the first thing that comes to mind. However, with a growing market in mobile healthcare technology, wearable devices and health trackers, there are a number of companies that stand to profit with some change in regulation.
A recent article from Politico profiled the recent advances made by lobbyist from such tech giants as Intel and Apple. They are working to force the U.S. Food and Drug Administration (FDA) to change the regulations of medical devices. In the fourth quarter of 2014, Apple spent $1.2 million on issues like health data and mobile health devices. In all of 2014, Intel spent $1.5 million lobbying for telehealth wearables, remote patient monitoring, patient-generating data for meaningful use Stage 3 and other health IT issues.
Why they are fighting makes sense when you consider research firm MarketsandMarkets predicts the wearable technology industry will be worth $11.61 billion by 2020.
Earlier this week, the FDA announced that it would not regulate technologies, that receive, transmit, store or display data from medical devices and medication applications. The agency also clarified existing guidances as for why this would be the case.
"Through these actions, we continue to clarify which medical devices are of such low risk that we will no longer focus our regulatory oversight on them or we will regulate them under a lower risk classification, narrowly tailoring our approach to the level of risk to which patients or consumers are exposed," wrote Jeffrey Shuren and Bakul Patel of FDA's Center for Devices and Radiological Health (CDRH). "Through such smart regulation we can better facilitate innovation and at the same time protect patients."
While this is certainly a starting point, tech companies want more. Specifically they are asking for the guidances to be built out into complete laws that protect the tech companies from federal intrusion when it comes to innovation.
The technology industry does have support from some members of Congress. Representative Marsha Blackburn (R-Tenn.), is championing the SOFTWARE Act, while Senators Orrin Hatch (R-Utah) and Michael Benet (D-Colo.) have a similar bill in the senate. Both of them would establish concrete limits to what the FDA can regulate.
“It is clear from the recent guidance documents released by the FDA that they intend to maintain regulatory discretion – that is they can change the rules whenever they want. Guidance is not the way to go,” Blackburn told Politico. “My legislation will provide the clarity and transparency needed as well as codifying the proper authorities of the FDA.”