FDA to Exercise Enforcement Discretion
Kathy McCoy, MBA
Follow her on Twitter @kathymccoy
I’ll just admit it right now: I’ve been a fan of Star Trek for years. This may be why I’ve also become a fan of mHealth. The idea of a “tricorder” instrument that can scan the human body and “beam” information back to a doctor seemed ideal to me then, and still does now.
That’s why it was a relief to me, as it was to many in healthcare and those managing chronic diseases, when the FDA announced on Sept. 23 that it “intends to exercise enforcement discretion (meaning it will not enforce requirements under the Federal Drug & Cosmetic Act) for the majority of mobile apps as they pose minimal risk to consumers.”
The agency said that it “intends to focus its regulatory oversight on a subset of mobile medical apps that present a greater risk to patients if they do not work as intended.” You can learn more about the types of apps the FDA will regulate in this GovHealthIT.com post.
This differentiation, of course, makes a great deal of sense. Many medical apps currently on the market, such as weight loss, exercise monitors, and others, pose no threat to patients even if misused. More clinical apps (that function as medical devices or in conjunction with medical devices) which can significantly affect patient health will undoubtedly be developed going forward, and those should be reviewed as medical devices. But many in mHealth are relieved that non-clinical apps will not be held up by FDA review.
mHealth is an exploding area of health IT, and offers a great deal of promise for better management of chronic diseases. The market currently includes 2.8 million patients worldwide, according to a January post on the mHealthWatch blog, and is projected to exceed 9 million by 2017. Experts project that revenue from mHealth will exceed $26 billion by 2017.
Patients are adopting this type of technology at a rapid rate; sales of advanced remote patient monitoring systems increased from $8.9 to $10.6 billion USD between 2011 and 2012.
I along with others see tremendous potential for better health management with mHealth due to the fact that it puts healthcare management where the patients are. I know I have many times delayed or ignored recommended tests due to the inconvenience. Having this type of health management at my fingertips would reduce my level of noncompliance, at least in some areas.
In addition, there are tremendous potential benefits for the chronically ill and the elderly. For example, my father is a diabetic, and getting him to effectively monitor his blood sugar levels is a challenge. After surgery a few years ago, he insisted his blood sugar was at a normal level—but when I pressed him to test it, he found it was over 400. Using mHealth to monitor chronic illnesses such as diabetes offers huge potential for better compliance and management. Instead of my father having to call his endocrinologist (and wait for a call back) for help managing his blood sugar, the doctor could have been receiving regular reports via an mHealth application and could have proactively changed his medication protocol.
And in fact, a study published in the Journal of Diabetes Science and Technology (Volume 7, Issue 3, May 2013) found that mobile health can positively impact patient engagement, clinical outcomes, and operational workflow in remote monitoring programs. The study, discussed in a recent article on HITConsultant.net, showed that use of wireless devices improves patient engagement due to its:
• ease of use
• real-time transmission of data
• increased device portability within the patient’s home
Monitoring, of course, is just one of the ways that mHealth can improve healthcare. The mHealth News reported that the HIMSS Mobile Technology Survey, released on Dec. 3, 2012, revealed that the top ways in which mobile benefits patients are:
• Pharmacy management (i.e. medication reminders, medication reconciliation);
• Care continuum (i.e. remote patient monitoring, post-acute readmissions);
• Resource use (i.e. access to supplies, medication utilization, marketing); and
• Preventative support care (i.e. wellness management, disease surveillance)
As mHealth News summarized, “The reality is that improving health outcomes involves changing patient behavior – taking medications, attending follow-up appointments, adhering to a diet and exercise plan.”
This is an area where mHealth can facilitate improved patient care, with minimal increase in use of physician resources. With concerns about shortages of primary care physicians, this could be extremely useful.
So, let’s boldly go. We’ve been waiting a long time for the tricorder.
Kathy McCoy, MBA, has written on practice management and revenue cycle management for more than 5 years for leading medical software, medical marketing and medical billing companies. She has more than 17 years of experience in continuing medical education, developing programs with respected educational institutions including Columbia University, Johns Hopkins, and Cleveland Clinic. Contact Kathy at contentperformance@gmail.com.