Three agencies are charged with regulating the health sector.
The regulation of health IT was always bound to unspool slowly, given the involvement of multiple agencies with overlapping jurisdiction and a rapidly changing and important industry. The first piece of finalized health IT regulation, which laid out rules for mobile applications, was released Sept. 23 following two years of debate. The government is required to outline its plans for the rest of the sector by January.
Health IT has the potential to lower costs and improve productivity in the health care sector, which has recently stagnated. New developments in health IT could make doctors' tasks more efficient or replace them entirely, a shift that would square with Obamacare's incentives for providers to deliver quality care at a lower cost.
Three agencies are charged with regulating the sector: the Food and Drug Administration, which will approve some apps and software and oversee the use of IT in clinical practice; the Federal Communications Commission, which manages wireless spectrum; and the Office of the National Coordinator for Health Information Technology, which oversees electronic medical records. The agencies have indicated they will take a flexible approach to health IT regulation in the hopes of encouraging innovation.
The FDA said on Sept. 23 that it will largely waive enforcement for apps with non-dangerous functions: those that transmit information from a patient's electronic health record; help manage a health condition without offering patient-specific advice, such as offering general diet tips for a diabetic; or provide simple calculations, like body-mass index.
The agency will be more strict with apps that control or mimic regulated medical devices, such as an app that can show electrocardiograms, and apps that provide patient-specific analyses or diagnoses—for example, an app that takes pictures of skin moles and determines whether they are likely benign or malignant. The FDA may require premarket clearance or approval for these.
The regulations issued in September left the some questions unanswered; the agency still hasn't decided how to regulate software that helps doctors make treatment choices. And the decisions it has made don't cover the entire sector, which also includes software that controls medical devices or electronic health records. That's where the other agencies come in.
A 2011 law, the FDA Safety and Innovation Act, mandated that the FDA, FCC, and ONC deliver a report to Congress by January 2014 outlining their framework for regulating health IT. The agencies convened a work group comprised of experts and industry representatives, which delivered a report in September recommending how the agencies should construct their final report (bureaucracy at its finest).
The work group's recommendations echo the FDA's mobile medical app guidance. Members think the agencies should exercise light oversight over simple software and more closely monitor complicated, risky technology, the software that substitutes its judgment for humans' in medical situations.
They have a lot of snake oil to look out for. A January study in the journal JAMA Dermatology examined four apps purporting to diagnose skin cancer based on a picture of a mole. The results were poor; the odds of a positive diagnosis being correct ranged from 6.8 percent to 98.1 percent; negative diagnoses similarly varied in accuracy. The authors blamed a "lack of regulatory oversight" for the wide range in quality.
Earlier this year, FDA cracked down on the mobile app uChek, which uses an algorithm and the iPhone's camera to perform urinalysis. The app's makers lacked the agency's clearance to market those capabilities, and the technical specifications on their website revealed that the company's data fell short of typical FDA standards. FDA sent them a letter requesting it come into compliance.
Similar cases are likely to proliferate now that FDA has announced its approach to regulating this market. The agency said in September that it will allow offenders "reasonable time" to comply before facing the consequences. The agency declined to answer in a Sept. 26 Twitter chat exactly how it would conduct enforcement against mobile apps.
The Federal Trade Commission is expected to join the FDA in enforcing rules for mobile apps and health IT generally. The FTC has cracked down on false marketing claims by mobile medical apps in the past; in 2011, the agency pursued action against several "acne cure" apps that led to settlements. Officials from the agency have suggested it may require randomized controlled trials to back up certain medical claims.
FDA's guidance on mobile medical apps specifically exempts physicians who tweak apps for their own use from manufacturer requirements, and that separation of developer and practitioner is consistent with the work group's recommendations for health IT. But that underscores part of the difficulty with overseeing the sector: Small, local changes may result in errors—or misuse—that have nothing to do with the developer.
That's where local regulators, who are closer to the action, are likely to come in and help determine where something went wrong. Health IT often involves chained-together functions; a piece of software might control a medical device, which feeds data into an electronic health record, which is monitored by another medical device's software, which could affect how a patient is treated. It isn't known how many errors or adverse events are attributable to health IT for the same reason, the agencies' work group said.
It's something that needs to change if health IT is to work well. Regulators, even as they recognize the potential in the sector's future, will have to pay close attention to the pitfalls of the present.