Mobile Medical Applications and the Affordable Care Act
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.