The ever-expanding mobile application market could be full of opportunities for savvy health IT professionals, but they must navigate a minefield of federal oversight and regulations to avoid legal entanglements that could ruin their fortunes.
Last week, six Republicans in the US House of Representatives sent a letter to the FDA Commissioner and FCC Chairman that asked for a progress report on how their two regulatory bodies are working together to co-regulate wireless medical device technologies. The two agencies established the importance of this regulatory relationship in July 2010 when they signed a Memorandum of Understanding (MOU).
The six House members that signed the letter, Rep. Marsha Blackburn (R-TN), Rep. Joseph Pitts (R-PA), Rep. Greg Walden (R-OR), Rep. Brian Bilbray (R-CA), Rep. Michael Burgess MD (R-TX), and Rep. Phil Gingrey MD (R-GA), expressed enthusiasm about the new applications and technologies, but said they were concerned that “a complex regulatory framework could inhibit future growth and innovation in this promising market.”
The FDA has said that it regulates apps that are used as an accessory to an already regulated medical device or that transform a mobile device into a regulated medical device. According to the MOU, the FCC enters into the relationship as an agency that regulates and provides for “effective operation and communication between radio devices, including allocation of frequencies and specification of technical requirements to avoid harmful interference between users.”
But the FDA and FCC aren’t the only federal agencies that app makers must navigate in looking to bring their products to market.
During a panel discussion in March, FDA’s Policy Advisor Bakul Patel, explained how his organization must also work with the Federal Trade Commission when it comes to regulating mobile health apps.
At the discussion, FTC Attorney Cora Tung Han, explained that his agency has already had to take actions against an app maker that they said had made spurious claims.
“(The actions) involved a case against marketers of apps that claimed to treat acne through a light emitted from the device if you held it close to your face. We alleged that those claims were unsubstantiated,” Han said.
Patel and Han explained that modern-day “snake oil” salesmen could come under scrutiny from either the FDA or the FTC. If there is no potential for harm in using the app, the FTC would have jurisdiction over the investigation, Patel said. Han said that in addition to coordinating efforts with the FDA, FTC does have jurisdiction for health breaches when the entities involved are not covered under the Health Insurance Portability and Accountability Act (HIPAA).
Violation of HIPAA’s Privacy and Security Rules is something that has the potential to land app makers in hot water with another government agency—Health and Human Services, or HHS (although technically the FDA is a part of HHS). The Office of the National Coordinator for Health Information Technology (ONC) typically enforces HIPAA violations, like the leaking of sensitive health information.
In conclusion, app makers must ensure that their products pass FDA guidelines, do what they say they due to avoid FTC action, and transmit any sensitive information in a private and secure manner on the particular wireless frequencies designated by the FCC.