Welcome to the World of the Prescription App
The evolution of pharma from a researcher, manufacturer, and distributor of molecules to a service provider, community builder, and health and wellness manager is imminent. The inevitable and inexorable trend of going “beyond the pill” demands focus on patient outcomes rather than drug sales, and is already putting tremendous pressure on the industry to transform in a manner akin to IBM shifting from hardware to software to consulting.
Seismic tremors reverberating from healthcare reform add urgency to the patient-centric revolution, with a primary focus on technology. Meaningful use requirements already demand progressively increasing utilization of electronic health records (EHR) to improve quality, safety, efficiency, and reduce health disparities through data capture and sharing, advanced cross-channel integration, and demonstrably improved patient outcomes.
The FDA also understands that mobile apps are in the eye of the digital health storm, beating even their long sought after social media guidance with final guidance on mobile medical apps, recently followed up with clarification around medical device accessories. The good news is most apps don’t require 510(k) clearance; the not-so-good news is those that fall into the unregulated category have little to no formal oversight or proven quality standards.
Physicians similarly acknowledge both the potential and the pitfall of mobile health, Manhattan Research revealing that a third of them already “prescribe” mobile apps to their patients—but only half recommend specific ones due to concerns about liability, and inability to differentiate the good, the bad, or the ugly from the over 40,000 health and wellness apps currently available on iTunes, and Google Play, and numerous third-party sources.
A recent paper from JAMA urged a formalized, unbiased, and scientific mobile health app certification process to meet this increasing challenge. Several companies have already addressed the need to varying degree, so let’s take a quick look at the history and current landscape. With opportunities abounding for pharma, medical device, and managed care companies to take full advantage, the era of the “prescription app” has finally arrived.
Early but Incomplete Bridgehead: Happtique
Founded in 2010 by the business arm within the Greater New York Hospital Association, Happtique took the first formal step at taming the “Wild Wild West” of mobile health by creating a proprietary and fully dedicated mobile health app platform. Understanding that quality control was even more important than distribution, Happtique created its own certification program to help ensure apps were professionally vetted and safe.
But the devil is always in the details, especially for digital, the plug rapidly pulled on the Happtique certification program after several randomly selected apps were found to contain glaring security glitches. Restructuring and refocus also shook the company, executive team leaving and the “iTunes of mobile health” aligning more toward servicing a few larger institutional customers than being a more general resource for physicians.
The debacle illustrated the challenges inherent in certification: The sheer proliferation of so many apps makes vetting and certifying them all arduous if not impossible, long and cumbersome review cycles inevitable and frustrating. But even if an app is determined to be safe and its information clinically accurate, the question is still begged as to its relevance to a particular patient under particular circumstances. Who is to be the judge, and how?
Public and Private Platforms: NHS and Wellocracy
Undaunted by the scepticism, two organizations continue to review, recommend, and help distribute mobile health apps. The National Health Service peer-reviews and tests health and wellness apps to ensure they are safe and clinically accurate. An interdisciplinary group of vetted experts also make recommendations and provide points of view on mobile health, and how to integrate their “approved” apps into a holistic treatment regimen.
Wellocracy is a new initiative developed and run by the Center for Connected Health at Partners HealthCare. Their mission to “inspire and empower individuals to self-manage their health and wellness,” Wellocracy goes beyond “app reviews” and brings the patient directly and interactively into the mix with assessment tools, motivational strategies, expert guidance and mentorship, and up-to-date informational resources.
As we’ve seen, mobile health is playing a pivotal role in consumer electronics, center stage at CES, and fueling the “Wearable Wars” between Samsung, Google, and Apple. But in order for mobile health to provide genuine patient value, their physician must be inextricably involved, and the app must become an integral component of the healthcare system. Overcoming professional hesitancy and integration hurdles are therefore paramount.
A Path Forward: IMS Health AppScript and Quantified Care
The Holy Grail of mobile health is therefore a platform from which physicians can prescribe, integrate, and track wellness, prevention, and treatment apps for their patients, akin to drug formularies. Best known for their mountain of physician data, IMS has expanded their specialty into mobile health by building a proprietary platform that hopes to accomplish exactly that: Become the definitive source for the next iteration of “mobile health Rx.”
Built on their “AppNucleus” technology, AppScript hosts a HIPAA and HITECH compliant infrastructure hosting healthcare apps that leverage IMS Health’s comprehensive data on diseases, treatments, costs and outcomes. A suite of services including messaging, surveys, and a PHR enables patients and physicians to exchange health information via a secure, encrypted channel across their mobile devices and integrated with health IT services.
Quantified Care takes an expanded approach, going beyond health app curation to help physicians synthesize the quantified self with the “Internet of Things” (IoT). By prescribing an entire ecosystem of interconnected tools that capture data and provide feedback, the platform provides immediacy, efficiency, and interoperability between physicians, patients, institutions, and their otherwise fragmented devices, services, and communication streams.
Implications for Pharma and Key Takeaways
The path forward seems clear enough, even though the exact route remains anybody’s guess. The ideal scenario involves a physician prescribing patients not only treatment solutions, but fully vetted and integrated mobile apps designed to ensure proper administration, communication of safety and efficacy, and reinforcement of adherence and ongoing support. Data is shared, and becomes meaningful input for the next point of care touch point.
Up to now pharma and device companies have dabbled in mobile apps, questionable physician adoption and engagement plaguing their development. But thanks to the new era of mobile and wearable tech, coupled with platforms like AppScripts and continued guidance from the FDA, the next steps in mobile health are becoming increasingly clear and beckoning. Baby steps have lead to a steady, determined crawl:
- Continue to monitor the progress of platforms like AppScripts, Quantified Care, and other startups poised to revolutionize the space
- Develop branded and unbranded apps suitable for inclusion within these proprietary “mobile app formularies”
- Discover pathways toward integration with EHR and PHR systems to facilitate and encourage communication between physicians, patients, and managed care
- Experiment and embrace “agile creativity” to enter and explore the channel, one poised to completely transform the face of pharma
- Partner with digital health experts with proven chops in content strategy and IT who can help bridge the gap between relevance, safety, and adoption
Do you think the industry is ready to finally embrace the inevitable? Are you ready to enter the next phase of the mobile health revolution? Klick is eager to continue the conversation, and partner with the industry’s top digital health leaders. Follow @SpitzStrategy, @bdkais, and the Klick blog for the very latest mHealth news.