The present state of affairs of mHealth is such that its most enthusiastic proponents are those in the industry itself. This stems from the lack of awareness of mHealth which may ultimately range from publicity of an extremely useful healthcare tool to its full utilization, which may change the framework of all healthcare delivery. One can debate at this point how developed or essential this technology will evolve into. Those in the industry are appropriately enthusiastic about the possibilities based on a number of observations. Healthcare is at the point of being unacceptably costly to not just the American society but of all Western societies. It is interesting that the USA and Europe have traveled very different paths on the road of healthcare delivery and financing but have both arrived at the same prohibitive cost place at roughly the same time. Contributing to this is the high cost of developing and adopted technologies in healthcare delivery, as well as provider shortages. Mobile health has seen its biggest adoption and successes thus far in underdeveloped nations where shortages of both finances and providers has been historically abysmal. Mobile technology, primarily in the form of cell phones has risen more rapidly there than in developed nations because of the lack of communication infrastructure including the Internet.
There are many mHealth technologies in use today and even many more in development. The range of utility corresponds to the many areas of healthcare. From wellness and preventive medicine to behavioral aspects of patient-centric care, and treatment of chronic diseases (vis a vis frequent messaging with a provider, medication, prescription, and appointment reminders). Mobile health brings closer the patient and caregiver as well, putting them in many instances literally ‘on the same page’ of healthcare information and protocol. They are all intended to decrease healthcare costs and/or result in better outcomes or maintain wellness. The technology is a huge paradigm shift in medicine insomuch as it has the patient as the center and focus of healthcare (a logical place but heretofore has been the provider). The extreme diversity of services (a tribute to the developers that have the insight to address all these aspects of health and disease management) itself feeds to slow adoption progress. How, one may ask? It doesn’t, by definition, lend itself to a single identity known as mHealth which can be easily related to by society, legislators, payers, providers, and consumers, in other words, all the stakeholders in health care. There are already different standards that are now set for mHealth technologies, as recently laid out by the FDA. These standards are appropriate insomuch as some apps have more direct medical consequences as others, and there is a difference with regards to patient confidentiality.
The proposed regulations can be found at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm263280.htm
So what will it take for mHealth to gain traction if it is to be recognized, adopted and effective?
- Recognition: It may take a combination of things for mHealth to become part of the lexicon of everyday discussion about healthcare among all people. Perhaps a breakthrough technology that affects such a substantial illness or population sector that it cannot be ignored. It may take a celebrity to bring the issue to the mainstream press (stranger things have happened). It may take a champion in the White House or Congress to highlight the industry.
- Adoption: This is another stumbling block. There have been many recognized beneficial advances in diagnosis, treatment, and awareness initiatives which have been slow to become adopted. This is the human factor in healthcare. Mobile health is dawning at the same time that electronic health records are, with the latter gaining more traction primarily due to mandates and financial incentives. They both have the same goals of improved outcomes at cost savings. Randomized clinical trials are the way drugs and devices are typically approved by the FDA and approved for reimbursement by CMS and others. Realistically, reimbursement should always be tied to something that has been shown to be beneficial. Many times something that intuitively is beneficial is shown not to in an objective well run study.
- Effective: . Clinical trials are sorely needed for mHealth technologies. This was well stated by Dr. Harlan Krumholz, a well-known physician champion of evidence-based medicine. http://www.technologyreview.com/business/38483/?p1=BI
They must be rigorously designed to show technology feasibility and clinical benefit to the consumer and provider, and cost efficiency to the investor and payer. The follow-up needs to be long enough to demonstrate a statistical significance that would uphold scientific review. The pilot studies thus far performed are little more than intriguing to stakeholders, industry participants or investors/ observers. They are not evidence that the specific technology is useful in a meaningful way.
Capital investors are at this time at most lukewarm about mhealth technologies. Uncertainties about reimbursement as well as lack of objective clinical trials are the main concerns. These are benchmarks of medical devices. The best chance for success is going to be for developers of technologies that believe in the benefits of their products, the mindset to subject them to rigorous trials, and to join together with others in the industry to raise awareness about a very exciting addition to healthcare.