Health industry wants 'clarity' on m-health regulation

The healthcare industry needs "guidance and clarity" from the federal government on how potential regulation of wireless medical technologies will affect cost, quality and access to care for patients wishing to take advantage of new innovations, the Wireless-Life Sciences Alliance says.

In comments submitted to the Food and Drug Administration and the Federal Communications Commission last month, the trade group makes four recommendations as the two agencies develop a regulatory framework for wireless and mobile healthcare:

  • In evaluating new devices, government regulators should consider the risk of maintaining the status quo by not approving an application.
  • They should take into account use cases and marketing claims before deciding whether to approve a product. "An example is comparing the needs of an 'aging-in-place' service [where gaps in connectivity can be managed] and a wireless ICU monitor [where connectivity must be substantially 'perfect']," the group says.
  • Regulators should establish "quality-of-service expectations" based on marketing claims rather than specifying which standards the applicant must follow. This takes into account the fast pace of change typical of consumer electronics and mobile services.
  • Manage risk of new products based on post-market surveillance and reporting.

In a panel discussion at last week's mHealth Initiative networking conference in San Diego, it was noted that it can take three to five years to bring a medical device to market under current regulatory processes. In the consumer world, tastes and needs change so rapidly that a product would be obsolete by the time it went through a traditional review.

"The regs probably need to be updated because they were written before people thought of 'lifestyle' issues" such as aging in place, said Bradley Merrill Thompson, a healthcare attorney with Epstein Becker Green in Washington, D.C.

Thompson, a member of the private-sector mHealth Regulatory Coalition that is developing a proposed regulatory scheme on behalf of various healthcare interests, said that federal officials welcome such input. "The FDA is so understaffed that they'll probably be happy to accept the draft that the coalition will [write] this fall."

For further information:
- see this Wireless-Life Sciences Alliance press release
- read the comments the alliance submitted to the FDA and FCC (.pdf)