Officials debate the future of mHealth regulation and implementation
The Patient Protection and Affordable Care Act may have made health information technology a priority, but not all forms of HIT are getting equal consideration under the healthcare reform law. The ACA laid the groundwork for the Centers for Medicare and Medicaid Services' meaningful use incentive program to spur adoption rates of electronic health records. The meaningful use initiative also established criteria for the effective implementation of EHRs in order to streamline medical practices' diagnostic, communication, billing and filing procedures.
While EHRs have received plenty of attention from the federal government, mobile health devices have flown below the regulatory radar for some time, despite growing industry interest in their capabilities. The U.S. Food and Drug Administration is expected to release final regulatory guidelines on mHealth usage, but these regulations have been delayed indefinitely. In the meantime, government and industry organizations are debating the role that regulations should play in developing mHealth technologies.
Waiting on FDA mHealth guidance
Healthcare IT News reported that various healthcare organizations operating with the mHealth Regulatory Coalition recently wrote a letter asking the FDA to officially finalize mHealth regulations, which were first announced in 2011.
"The MRC believes the timely release of the final guidance will benefit industry, stimulate investment, help ensure patient safety and is consistent with the views expressed by Congress and the desires of the broader mHealth community," wrote Bradley Merrill Thompson, an attorney in Washington, D.C., and MRC member, in the June 21 letter. "[This] is needed by industry and will help unlock investment in the mHealth market. Many investors and companies are reluctant to invest significant time and money in mHealth technologies until the regulatory framework is clear."
However, due to this nearly two-year delay, some critics are saying that the FDA may not be the appropriate body to regulate mobile HIT systems. The Institute of Medicine wrote a report backed by the Office of the National Coordinator for Health Information Technology stating that the FDA should not have a hand in mHealth regulation. This is because further delays and lack of clarity from the FDA could potentially destabilize the emerging mHealth market while also leaving patients vulnerable due to insufficient regulatory oversight.
Congressional recommendations for mHealth regulations
Aside from various government agencies and healthcare organizations debating mHealth guidance by the FDA, members of Congress have also voiced their opinions on healthcare reform. According to FierceMobileHealthcare, Rep. Chris Collins of New York has weighed in on what he believes is the ideal course of action regarding mHealth technology. Collins is currently the chairman of the House Small Business Subcommittee on Health and Technology, and he has suggested that the federal government dial back regulations for small mHealth app developers. Collins believes that too much government oversight may cripple this area of technological innovation before it even gets off the ground.
This is especially relevant in Collins' mind considering the two-year delay in FDA mHealth regulations. While the lack of certainty surrounding federal guidelines has created a tense situation in the healthcare industry, Collins noted that small businesses are continuing to press forward in changing the face of HIT.
"Entrepreneurs don't wait for the final regulations before they start. They find a solution to a problem and try to be first to market," Collins told the news source. "They are not dragging their feet waiting for final regs. They just understand that if and when final regulations come out they might have to tweak their product. They're going full bore and well aware that they may have to adapt. That's what entrepreneurs do."
