#mHealthEthics: A Call for Pharma to Develop Mobile Health "Guiding Principles"

According to a "Client Alert" from Pillsbury Winthrop Shaw Pittman LLP, FDA’s new draft guidance that would exempt from premarket 510(k) review many low-risk medical devices may "smooth the path to market for many medical mobile apps that the FDA’s 2013 guidance suggested would be subject to premarket approval requirements." By "certain devices," the authors mean those that can convert a cell phone into a medical device, such as a thermometer or a stethoscope. Before the 2013 guidance was released, Bradley Merrill Thompson, General Counsel for the mHealth Regulatory Coalition, thought such apps could be considered medical devices by the FDA. His case study involved a urinary analysis iPhone app -- no, you don't pee on the phone! Listen to this podcast: Beyond Mobile Medical App Guidance - What to Worry About After FDA Publishes Its "Final" Guidelines. But Pillsbury et al touch on other issues regarding such mobile apps/medical devices: "All app developers should consider whether their products may face other government oversight or legal challenges. In particular, health information privacy and security is an important aspect of health technology and protection against cyber threats and attacks is crucial. A digitized medical environment, while improving care and access, can be readily exploited by opportunistic hackers. Players in the health IT space should be highly cognizant of this risk and take steps necessary to limit...
Source: Pharma Marketing Blog - Category: Pharma Commentators Tags: Ethics Mobile mobile medical app Source Type: blogs