Mobile Medical Applications and the Affordable Care Act

Such applications will transcend the ‎landscape and hopefully result in better quality care which will be most cost-effective, according to the author

OPINION -- Returning from the American Medical Informatics Association (AMIA) annual symposium in ‎Washington, DC, at the end of November, I reflected on what issues seemed to be hot given health reform, what was the buzz in the halls, and at the breaks. Given that a large portion of the attendees ‎were not from the United States, I also tried to ascertain what my colleagues across the globe in the ‎Clinical Informatics space were thinking.

Much of the discussions centered around ‎telemedicine/telehealth, the use of social media in healthcare, and mobile health or mHealth and ‎mobile medical applications. The latter may be defined as a mobile application that meets the Food ‎and Drug Administration (FDA) definition of a medical device and is intended to be used as an ‎accessary to a regulated device, or to transform a platform into a regulated medical device.‎

Quality and cost-effectiveness in the context of the delivery of healthcare was important, along with ‎its increasingly patient-centered nature. There were discussions about the seemingly antiquated laws ‎that make it difficult for telemedicine to keep up with the technology. For example, some wondered ‎why a patient in New York had to have his or her x-ray read by a physician licensed in New York, when ‎the film was being read in Bangalore.

Some were concerned about the privacy and security issues ‎associated with patients being on social media for a chronic condition, and whether the information ‎they had was credible. Others, however, thought that such social media sites made it possible for ‎patients to have information much sooner than waiting for the results of research studies to be ‎published in journals that they may or may not be able to access.‎

It seemed to be a common consensus that the use of mobile devices in the delivery of healthcare and ‎in obtaining healthcare knowledge was becoming ubiquitous. Physicians and other caregivers wanted ‎to use their devices for a variety of purposes, and many prefer their own devices to a laptop or work‎ station with which they were provided. The BYOD (bring your own device) concept was certainly on ‎the minds of attendees and its anticipated and unanticipated consequences. Patients also now BYOD ‎for their care, e.g., whether it is in the context of locating additional information about what malady ‎they might have or accessing the results of their lab test.‎

The recent FDA Guidance for Mobile Medical Applications was on the minds of many. Particularly, ‎some individuals, including entrepreneurs were wondering whether the guidance would facilitate the ‎development of such devices under health reform, or stymie it. Unfortunately, as I have penned in ‎another venue, the guidance is not clear.

The FDA provides some idea of the types of mobile medical ‎apps that it believes are subject to regulatory oversight, and those that it will exercise enforcement ‎discretion and not seek to regulate at this time. We know that a mobile medical app that is an extension ‎of a medical device by connecting to one will be considered a regulated device if it displays, stores, ‎analyzes or transmits patient-specific data.

We know a mobile medical app will not be considered a ‎device over which the FDA will exercise jurisdiction, if it helps patients self-manage their disease or ‎conditions without providing specific treatment or treatment suggestion. We know mobile medical ‎apps which perform patient-specific analyses and provide patient-specific diagnoses or treatment ‎recommendations will be regulated. However, ones that enable patients or providers to interact with ‎Personal Health Records or Electronic Health Record systems will not be considered a medical device ‎over which the FDA will exercise jurisdiction.‎

Under health reform, facilitated by the Affordable Care Act, (ACA) many can envision that mobile ‎medical apps will become increasingly important in this new patient-centered care environment. We ‎know that entrepreneurs and others will seek to develop applications which will help to implement ‎advancements in science, including evidence-based medicine and biomedical informatics before much ‎of the results are published in the scientific literature.

We know that if patients are demanding that ‎they be able to e-mail their clinicians, and that many clinicians are demanding that someone pay them ‎for their being accessible via e-mail to better provide care for their patients, the ACA will only result in ‎more mobile medical applications being developed and more technology being employed in the ‎delivery of healthcare.‎

Returning from the AMIA meetings, I consulted with one of my colleagues at the Schwabe firm, Bruce ‎Howell, who is in my opinion one of the leading ACA experts in the country, about mobile medical apps ‎and health reform. In fact, Mr. Howell was asked to teach the inaugural course on the ACA at the ‎Willamette Law School this winter.

Mr. Howell not only agreed with the consensus that I saw at the ‎AMIA meetings regarding mobile medical apps, he also noted that telemedicine/telehealth and social ‎media were key. Citing his background in genetics, he noted that these are only first steps, and that ‎the advances we will see in the delivery of healthcare information and technology will transcend the ‎landscape and hopefully result in better quality care which will be most cost-effective.‎

I was wondering whether Mr. Howell’s course was open to the public, and then my assistant reminded ‎me that in addition to practicing healthcare law in the winter, as I have done for the last 34 years, I am ‎also taking two courses at OHSU and co-teaching one on Health Information Privacy and Security. I can ‎only imagine how much work it will take to update the latter. Maybe I can “borrow” some of Bruce’s ‎materials.‎

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