Regulation of mobile medical apps is a hot topic everywhere lately, but the regulatory environment in the U.S. is especially heating up. Recently, two opposing coalitions petitioned the U.S. government with opposite requests: to move slowly and cautiously on regulatory guidance, and to provide final guidance immediately.
Melissa McCormack of Software Advice, a company that publishes buyer’s guides and other resources for medical software buyers, published a report analyzing each side of the regulation debate.
On the one hand, a group that consists mainly of medical provider associations, large IT companies, and managed care organizations would like regulation to move slowly. In reality, many in this group would like to avoid regulation altogether, and hope to delay it indefinitely.
Today, the U.S. Food and Drug Administration (FDA) regulates medical devices. They’ve claimed responsibility for regulating medical apps to the extent that an app performs a function similar to an existing device that the FDA regulates, or as an accessory to such a device. Some of these stakeholders have previously petitioned the U.S. government to bundle mobile apps in with the broader category of “health IT,” and to have all of health IT regulated by a new body created specifically for that purpose.
Makers of electronic health record (EHR) software, who comprise a nice chunk of the opposition group, may be concerned that the regulatory eye will turn to them next. Currently EHRs in the U.S. are not regulated, but rather “certified” by independent organization. EHR makers prefer to keep it that way and would seemingly like apps to be handled similarly.
Private pay companies are incentivized to avoid regulation. In the states, these insurance companies provide reimbursement to patients for medical procedures, drugs, and devices, and also to the doctors who prescribe them. FDA-approved medical apps would likely mean increased reimbursement costs for these companies.
The medical provider organizations are likely keen to see exhaustive research completed before more regulatory burdens are added to the medical industry. In addition, providers have raised concerns about the amount of time it takes the FDA to review medical devices (up to 20 months in some cases), and worry that regulation will stifle innovation because some app developers won’t be willing to invest the time and money required to comply.
On the other side of the debate, device and app makers along with mobile companies like AT&T and Verizon Wireless are pushing for final guidance quickly. App makers don’t want to spend time and money trying to comply with FDA guidelines only to find out their app won’t fall under the FDA’s jurisdiction after all (or conversely, assume an app won’t be regulated that will be).
Mobile companies side with the app makers. Mobile companies win when more apps are being made and used. They also point out that clear FDA guidance will give investors confidence to inject more investment in the industry.