The adoption of mobile devices in healthcare has already started and early on was driven primarily by the continuing evolution of the “electronic health record”. With HIPAA and a number of other laws providing a framework and timetable for their adoption by physicians and hospitals alike, many have been slow to adopt with time already run out for some.
Particularly pads are increasingly being used by physicians and staff with record systems that allow patient data to be entered directly into the database and finally eliminating the “scribble” long associated with handwritten notes. This also gives medical staff quick access to other networked resources that can aid in patient care.
Now with the “final guidance” issued by the FDA last September the race is on to begin to develop “mHealth apps” for patient use on mobile devices. Although still many gray areas exist and the guidance covered a very narrow spectrum of what the FDA considered apps that “pose potential patient dangers”.
Now the Consumer Electronics Association is taking that guidance on the road to clarify the requirements for app developers and help them to identify best practices being used by those who are already building regulated applications. Entitled the “Mobile Medical Apps (MMA) Roadshow: Managing App Development under FDA Regulation” the educational series is being held at multiple U.S. universities.
“There are huge opportunities for healthcare providers to monitor and diagnose remotely, and for individuals to take a major role in their own healthcare with fewer trips to the doctor,” said Gary Shapiro, president and CEO, CEA. “Consumers are increasingly using electronics to manage their health, and we are thrilled to support a program that aims to spur innovation by bringing more mobile apps into the healthcare space.”
Unfortunately there are some that are concerned with how complex the regulations already are and that it could squeeze smaller competitors out of the space. This could result in few useful applications and less overall innovation. Some of the problem is getting through the FDA review and with new legislation being introduced by Congress that would provide further guidance to the FDA concerning mobile health applications, it may get a bit more confusing further down the road.
Considering that this is a trillion dollar industry and that half of us already own smart phones and other “smart” devices, there is much at stake. Applications to provide better patient outcomes and pro-active medical activities are all on the horizon. Yet using the Internet to connect and control implants, or facilitate the transmission of medical data from patient to physician, or even providing self-help devices to monitor everything from weight to blood pressure; all would require up-time rules and privacy protections.
If your organization is considering developing mHealth applications partnering with experts in both development and the rapidly changing rules and regulations will mean the difference between success and failure. Although complicated even smaller start-ups and mid-sized existing medical businesses could bring both helpful and lucrative applications to market.
To be sure the MMA roadshow is the first place to start and there are still several schedule through the end of 2014. After that it is likely that MHealth application development itself will be well on its way to adding new devices to keep us fit.