Promise or Pitfall: 13,000 reasons the mobile app space can’t be ignored September 7, 2012 I’ve been excited to gain more exposure to the healthcare IT and medical media space during preparations for the MedtechVision 2012 Conference panel “The Internet’s Impact on Patient Health Management, Care Delivery, and Choice”. Medical apps, though a small segment of burgeoning Healthcare IT space, have been a very visible and arguably more mainstream area, which burst onto the scene around 2010 and have been growing about 150% each year since. These days it seems like there are apps to measure, record, trend, photograph, or answer (seemingly) just about anything health-related. Have I eaten more calories than I have burned? Can I send this x-ray to a doctor for a second opinion? How’s my blood glucose trending? Is this mole pre-cancerous? Is my ECG normal? This amounts to a staggering ~13,000 apps for patients/consumers, with another >5000 targeted towards medical professionals (MobiHealth News). The quantification of many aspects of daily life and new possibilities for interactions between patients and care providers does not come without a host of challenges. Several burning questions stand out in my mind (and pop up frequently in articles covering this topic)… How do we create and discriminate real clinical value out of mounds of gathered patient data, increased connectedness or new ways to incentivize patients? Or, how will these ventures be monetized in an effective way (which has often been elusive)? Finally, there’s large number of questions surrounding an unclear regulatory environment for mobile apps. Numerous apps are available to monitor things like fitness goals, for example, but with their ever-expanding scope to deal with chronic illnesses, triage care, or provide other critical diagnostic value, it becomes less clear how the FDA will regulate this quickly growing sector. The agency’s draft guidance outlines a small subset of apps that they are eyeing for regulation – those that are used as an accessory to a medical device already regulated by the FDA, or those that transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices – but this would only amount to a small subset of all medical- and health-focused apps. I found it surprising that I can count the number of health apps that have gained clearance from the FDA to date on my two hands. The other question that consistently pops up in this regulatory discussion is how to balance the mismatch of the agile life cycle of app development and the typical FDA regulatory process timelines. An increased focus from a regulatory standpoint still doesn’t address the higher-level questions of which apps will actually deliver clinical value at the end of the day. Physicians and consumers often end up wading through a sea of options for medical apps, many of which haven’t been tested with (any) clinical rigor and may not deliver much realized impact to the patient or care provider. A recent article in the New York Times mentions a different approach through a private regulation system. A company called Happtique has developed a method of vetting healthcare-related apps through their own quality guidelines (sponsored by Aetna) to essentially curate the cream-of-the-crop medical apps for patients and physicians. It will also be interesting to see how public or private review mechanisms will ultimately assess value between apps that intend to deliver more quantifiable endpoints (for example, better clinical outcomes, lower cost, or compliance with medical therapy), and ones that provide an improved patient experience, care-provider peace of mind, or other potentially worthwhile, but harder to quantify outcomes. According to Research2Guidance, the worldwide mobile health-apps will reach $1.3B in 2012, up from $718M in 2011. While aspects of the mobile app arena remain unclear, what is clear is that this will be a trend those in the healthcare space to watch. Despite the growth in the medical-related app space, it represents just a small sliver of the increased focus from investors, entrepreneurs, medical professionals, and healthcare providers in the broad and growing healthcare IT sector. I’m eager to hear the varied perspectives of the panelists at MedtechVision 2012 about the rising engagement of the patient in their own healthcare decisions and participation in their medical management in the larger healthcare technology ecosystem. Hope to see you there!