Three days of hearings by a House of Representatives committee concluded yesterday with a pledge from an FDA official to finalize long-awaited guidance on the regulation of mobile medical applications “in coming weeks“; at the latest by the end of the FDA’s fiscal year (i.e., September 30th).
The hearings, convened jointly by several subcommittees of the House Energy and Commerce Committee, were announced last week following a pointed letter to the FDA (pdf) from seven committee members on March 1st. In the letter, the Congressmen pressed the FDA for information on the agency’s mHealth regulatory timeline and the implications for innovation and industry of the proposed regulations.
A Preview of Guidance to Come. As covered previously here at the Genomics Law Report, in July 2011 the FDA released draft guidance (pdf) outlining its intent to regulate a limited subset of mobile medical applications based on their perceived risk to patients and consumers.
For years, and with increasing frequency, health care and information technology companies have touted the potential of mobile medical and health applications and technologies to improve the quality and delivery of health care through the use of technology. While the future of mobile health (frequently referred to as “mHealth”) is undoubtedly filled with promise, the legal and regulatory landscape in which mHealth technologies reside is only now beginning to take shape.
As mHealth developers, funders and even users consider investing in the field, or including in particular mHealth technologies, they should keep in mind the emergent and fluid nature of the mHealth regulatory landscape. Here, we outline the likely key players and discuss several recent and projected initiatives with respect to the oversight of mHealth technologies:
Amit Bhagwandass is a rising third-year student at University of North Carolina School of Law.
New rules adopted by the Federal Communications Commission (FCC) have an appreciable impact on the way that hospitals, nursing homes and other inpatient and outpatient health care providers will monitor their patients in the future. The new FCC rules enable the use of Medical Body Area Networks (MBANs). MBANs are low-power wideband networks consisting of multiple body-worn sensors that transmit various patient data to a control device that collects data from the sensors.
Wireless devices operating on the MBAN spectrum can be used to continuously monitor a patient’s health by measuring indicators such as blood glucose levels, blood pressure and electrocardiogram results. Additionally, wireless health devices can include mobile devices and associated applications of increasing relevance to consumer health and personalized medicine, such as mobile-device enabled sensors that monitor vital signs for any number of traits or conditions like blood pressure, glucose levels or even the early signs of an asthma attack.
The Federal Communications Commission’s (FCC) National Broadband Plan was released to Congress today. (Depending on your perspective, that’s either one day ahead or 30 days behind schedule.) What, you might ask, does a broadband report prepared by an agency better known for handing out fines in the aftermath of wardrobe malfunctions have to say that could possibly interest the Genomics Law Report?
For most of the broadband plan’s 376 pages (pdf) the answer is “nothing at all.” However, Chapter 10 focuses on Health Care (pdf), with several discussions of potential relevance to the future of genomics and personalized medicine, at least in the United States. The bulk of the chapter is devoted to issues of indisputable importance – e-care, health IT, mobile and rural healthcare delivery, for instance – that will be capably covered elsewhere. (mobihealthnews, for instance, is already providing coverage of aspects of the plan that will impact mobile health care: here and here.) However, Section 10.4 (“Unlocking the Value of Data”) offers up two important themes that are relevant to how at least one government agency views the future of genomics and personalized medicine.