With the growing use of mobile technologies in health care, the U.S. government is considering regulation of devices that are generically classified as “mhealth,” and a group of hardware and software producers of mhealth products are asking questions surrounding possible regulation of those technologies.
On Dec. 22, 2010, the “mHealth Regulatory Coalition” (which also includes health care providers and patient advocacy organizations members) released a report—A Call for Clarity: Open Questions on the Scope of Food & Drug Administration (FDA) Regulation of mHealth—that asks two questions with regard to regulation of mhealth. Those questions are:
- What mhealth hardward and software will the FDA regulate?
- If such products are regulated, in what device classification will the FDA place them?
The report delves deeper into the questions surrounding the regulation of mhealth, including in three additional areas. Those areas are:
- To what extent can mhealth-related products be excluded from FDA regulation?
- To what extent do mobile phones and other generic communications hardware become FDA regulated medical devices simply because they are promoted for connection to a medical device?
- To what extent does the FDA regulate software apps that are intended to reside on mobile phones, ordinary PCs, servers or in the cloud if they function to provide connections between communication hardware and medical devices, or as repositories for health data?
“The coalition tackles these questions because, quite simply, the answers are fundamental to the business planning process and companies, as well as investors, need answers as soon as possible to maintain innovation,” the report says.
However, the coalition “does not attempt to solve these problems,” the report says. “Rather, the coalition focuses on defining the myriad of problems and challenges that arise when attempting to apply current FDA policies and requirements to the future landscape of mhealth technologies.”
The report consists of five chapters with Chapter 1 providing “an overview of the problems that developers of mhealth technologies face given the current regulatory framework.” Among those problems is “defining mhealth for use in an FDA regulatory context,” says the report, which proposes “technology architecture” and “software platforms and interfaces” as the defining elements for regulatory purposes.
Chapters 2 through 4 describe the coalition’s “current understanding of FDA regulation of mhealth” and they provide “a broad industry perspective on the challenges posed by the existing regulatory environment. Chapter 5 returns to the original questions of regulation, and the report says the federal government’s “regulatory framework fails to provide clear guidance” on mhealth.
REGULATED AS A MEDICAL DEVICE?
Specifically, the coalition wants to know whether a mobile-technology product will be regulated as a medical device, because in the mhealth area, there can be “a grey area” between general health and wellness, and technologies used to diagnose and treat disease. Part of the reason for that is the technology architecture of mhealth devices can be complex and could include cell phones, Internet connections, data servers, health-care provider networks, and even billing and administration systems to list a few.
Through the report, the coalition says it “hopes to begin a discussion between mhealth stakeholders and the FDA regarding the regulation of mhealth technologies,” and that those discussions will result in a guidance document that provides a clear and predictable regulatory pathway that fosters innovation and ensures the safety and effectiveness of mhealth technologies.
The coalition has promised to provide a follow-up document in April 2011 that will propose solutions to the questions the group has presented.