As technology rolls on and with the various areas of safety, devices and drugs we are living with today, the FDA might just in fact become the “most connected” federal agency as much of the work and research being done today that falls under the jurisdiction of the FDA depends on information gathered by other agencies or private companies outside of what may be on file at the FDA. The NIH and FDA are already working together on projects as noted a couple months ago.
Back in April of this year I also touched on this topic as infrastructure at the FDA and almost all government entities is a huge project that needs to be addressed with getting the right technologies in the right places and not just updating in areas to create profits with transaction fees. It is complicated and as I said back then, partnerships with other agencies is key.
FDA Moving Toward Major Infrastructure Overhaul And It’s Getting Complicated – Partnerships With Other Government Entities is Key for Success
You can see by this example of having to award a grant to an insurance company that those shortages do exist with lack of technology in some areas.
FDA Awards a Big Grant to Health Insurance Company For Pilot Program To Monitor Safety of Drugs and Medical Devices
Perhaps with aligning with the FCC wireless and telehealth collaborations will take place to hopefully move this in an organized direction.
To add on one final footnote here, privacy issues are also at hand so again we want to grow this area without insurers penalizing patients and doctors with over utilization of analytic algorithms as you would have to be living under a rock today not to see how this is happening with all the stories in the news.
Just this morning I wrote about the increased use of wireless devices and left unmonitored with the flurry of acquisitions and mergers today, you may have no clue on who has your data and how it is being used. BD
Health Insurers Expanding the Use of Devices Reporting Data – Wireless Home Units or Sensors Worn to Submit Heart Rate and Other Vital Information
The Federal Communications Commission and the U.S. Food and Drug Administration have joined forces to help advance innovation and investment in wireless-enabled telehealth devices, which can improve the quality of a patient's health and reduce healthcare costs.
FDA commissioner Margaret Hamburg and FCC chairman Julius Genachowski signed a joint statement of principles and memorandum of understanding at the start of a two-day conference, which began on Monday, to showcase a broad range of cutting-edge wireless medical devices as well as discuss issues affecting the telehealth industry.