In a few short weeks, TCBI will be holding their 5th annual Medical Device Connectivity Conference in Herndon, VA (the Washington DC metro area), November 21-22. It seems like the first conference was only a year or two ago.
Medical device connectivity, or the more fashionable (and some might say, more descriptive) term interoperability, has both changed significantly and remained the same over these past 5 years. Lots has changed on the regulatory and HIT governance front. The FDA has issued guidance on mobile medical apps, wireless medical devices, and cyber security – just this year. The FDASIA report on regulating HIT was presented to the ONC, FDA and FCC.
Almost in tandem with regulatory advances, there is a growing awareness of the need to improve hospital IT governance to accommodate the safety-critical medical device systems that are increasingly supported by enterprise IT infrastructure. Examples start with the promulgation of IEC 80001 in 2010 and more recently to include an article I wrote last year, The IT/Clinical Engineering Governance Gap, and this year, the ONC’s grant for the SAFER project on best practices and risk management for HIT (reference article here), and ECRI Institute’s Health IT Hazard Manager and their overall focus on patient safety and HIT.
The creation of alliances to promote connectivity and interoperability grew this year as well. Both the CommonWell Health Alliance and the West Institute’s Center for Medical Interoperability were launched in 2013 for a total of 10 similar alliances I’m tracking in health care. These alliances join organizations like the IHE and Continua Health Alliance in working to realize medical device connectivity and interoperability.
In spite of a lot of activity, there are some things that don’t seem to change. Certainly manufacturer’s lack of interest in open standards does not seem to have changed. Systems integration continues apace, continuing the strategy of “one-off” interfaces and tightly controlled application programing interfaces (APIs). Connectivity stalwarts, the IHE – and especially the Patient Care Device domain have been consistently working to implement open connectivity between different manufacturer’s products and systems.
All of the above trends and activities are reflected in this year’s agenda. Three clear trends have emerged in this year’s agenda: medical device/HIT governance and regulation, cyber security, and wireless. Our goal every year is to provide timely and actionable information at the conference. I think we’ve achieved that goal this year with a cast of speakers from many exceptional institutions.
Thanks to all of our scheduled speakers for taking the time to tell your story at this year’s conference, increasing our knowledge and advancing the cause of connectivity. Thanks too to Satish Kavirajan, Managing Director of TCBI, for managing the schedule this year, and as always, producing a great event.
I look forward to seeing you all at the Herndon Hyatt later this month.