Category: Privacy & Data Security
The Debate Over Mobile Health Software Regulation
On November 19th, the House Energy and Commerce Subcommittee on Health held a hearing to examine the federal regulation of mobile medical applications (mobile apps) and other health software. Earlier, on September 25, the FDA released guidance on this issue, describing how it intends to regulate mobile medical apps pursuant to its authority under the Federal Food, Drug and Cosmetic Act to regulate “medical devices.” Lawmakers, however, are concerned with the expanse of the FDA’s authority and scope of the FDA’s interpretation of what constitutes a “medical device.” Accordingly, some legislators are pursuing new legislation to solidify a standard for medical software and restrict the FDA’s authority. The recent Subcommittee hearing focused on whether mobile health software should be regulated as a medical device and whether Congress or the FDA should set the rules.
The FDA’s View
While concern has arisen that … Read More »
FDA Final Guidance on Mobile Medical Applications
Summary
On September 23, 2013, the FDA issued a guidance (“Final Guidance”) explaining how medical device regulations will be applied to medical mobile applications (MMAs).[1] The Final Guidance provides mobile application manufacturers with recommendations on how to comply with the regulatory and statutory requirements governing medical devices. The Guidance indicates that the FDA intends to limit its enforcement authority to only those mobile applications that operate as medical devices and pose a significant risk to patients if they fail to function as intended.
The Final Guidance outlines three categories of mobile applications (mobile apps) generally: (1) mobile apps that are not medical devices as defined under the Federal Food, Drug, and Cosmetic Act and are therefore not subject to FDA regulation; (2) mobile apps that may meet the definition of a medical device but over which the FDA intends to exercise enforcement … Read More »
Impact of Healthcare Mobile Apps on Treatment
The use of healthcare applications on mobile devices continues to have a growing impact on medical treatment as consumers are using mobile devices to take more responsibility for their own care. Recently, digital marketing agency Digitas Health compiled data on the impact of mobile health care applications in “CONSUMER MOBILE HEALTH IMPACT ASSESSMENT: How the Use of Mobile Impacts Disease Treatment and Therapy.” Digitas’ findings provide useful insight for marketers and health and wellness brands looking for new ways to effectively reach patients and their physicians with information on available treatment options.
Mobile devices are becoming a continuous part of the healthcare process and are being used by patients in both waiting rooms and exam rooms. In fact, one in three patients surveyed claimed that either they or their physician used a mobile device in the exam room. The study shows … Read More »