mHealth, defined by HIMSS as “the use of mobile and wireless devices to improve health outcomes, healthcare services and health research”, is a booming field nowadays. Studies show that “64% of medical professionals are using mHealth on a monthly basis, and 78% of smartphone users are interested in mobile health apps”. That said, whether the app is created for physicians or patients, it must follow certain regulations. In fact, the regulatory future of mHealth was a hot topic of the November 19th Capitol Hill briefing. mHealth field is rapidly developing, so it is waiting for more resources and recommendations from the FDA, US Food and Drug Administration, and federal privacy laws.
What Is Regulated and What Is Not?
AAAS, the organizer of the event, has published an article that discusses its agenda and proposed course of action. “Determining whether technologies are regulated or are subject to medical privacy laws can be a complex task, particularly because mHealth encompasses such a broad range of technologies, according to the one of the panelists. FDA has started by determining which technologies it will not be regulating. The agency announced in February that it would not regulate the simplest mHealth technology: software that is used primarily to store, transfer, display, or convert data from a medical device, such as a program that stores blood pressure readings for later review”.
At the briefing, Bradley Merrill Thomson, the leader of the medical device regulatory practice and digital health practice at the law firm Epstein Becker & Green, noted that some industries using mHealth solutions such as of pharmaceutical must have regulations from both the FDA’s Center for Drug Evaluation and Research and the Center for Devices and Radiological Health.
The Department of Health and Human Services is also concerned about necessary regulatory issues. “HHS recently launched an online portal specifically for health app developers to ask questions about the Health Insurance Portability and Accountability Act (HIPAA)”.
Snappii, a rapid mobile business app development company, offers a mobile solution associated with HIPAA. HIPAA Compliance App is for individuals to provide HIPAA personal information on demand. The users can fill in the form and provide it to specialists to release their private information and allow medical establishments to access and use it. The app is available in Google Play Store and can be customized by Snappii to meet any specific needs.
It is extremely important that mHealth continues to be a viable solution and successfully develops as such technological innovations greatly contribute to a healthy and happy nation.