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.Read More
On June 7th, 2013 the Texas Children’s Hospital and Smith Seckman Reid are producing an educational workshop on medical device connectivity. Nursing is the predominate perspective explored in this event. (One of my pet peeves is all the focus physicians get from vendor’s marketing departments. Yet, when it comes to systems in hospitals, the predominate user – by far – is nursing.)
TCH, an early adopter of clinical documentation into EMRs and alarm notification, has some of the most extensive experience with medical device connectivity in the US. They’re hosting and presenting at this one day seminar. Here’s the blurb on the event, with links to where you can register. Besides the great content, the next best thing is the cost – free. The only downside is there’s room for just 150 attendees.Read More
Last month I spoke at the first CIS Qatar International Conference in Doha Qatar. My topic was the Importance of Enterprise Wide Medical Device Integration in CIS workflow. You can download a copy of my presentation here.
This was the first such conference in Qatar with over 1,500 people attending. The ballroom only had capacity for 1,200 so they had remote screens and audio for the 300 overflow attendees. Several hospitals in Qatar are in the process of implementing Cerner’s EMR, so there is a lot of keen interest in all things EMR.Read More
This September 8-9, in Boston, will be the third Medical Device Connectivity conference. We’re returning to the Joseph B Martin Conference Center at Harvard Medical School – a really nice facility with great food. Of course, the ambiance and cuisine is secondary to what you’ll learn at this year’s conference – still the only event dedicated to medical device connectivity.
Since last year’s conference so much has come to pass:
- The FDA published their final rule for Medical Device Data Systems, and signaled their intent to regulate health care providers who develop their own MDDS solutions.
- The FDA also published the long anticipated draft guidance on mobile apps, clarifying the boundaries around what is and is not regulated medical device software, and laying out a bit of the FDA’s enforcement strategy.
- The transition of health care technology from the hospital to home health has also received some attention from the National Research Council in their report, Health Care Comes Home: The Human Factors.
After missing last year’s meeting in Tampa, I’m back at AAMI – one of the two events that I try to attend every year. The focus on connectivity has increased as there is a full track devoted to the topic this year.
One change this year, is that my blog posts from the conference will be appearing on the Medical Electronic Design magazine blog, found here. As usual, I’ll also be taking lots of photos, some of which may also be posted on the MED blog. Eventually most all the photos (the good ones that aren’t confidential) will be posted on my Flickr account, here.Read More
I have an opportunity to conduct a post-conference workshop at this year’s Healthcare Unbound conference. This year’s event is in San Diego, July 11-12 at the Manchester Grand Marriott. The title for the workshop is, Developing a Regulatory Strategy for Your Healthcare Unbound Product. The workshop will be conducted the afternoon of July 12th. You can read the workshop description at the end of this PDF document.
The rationale behind the workshop is the need to clear up confusion on the part of many product developers regarding regulatory issues like,
- Is my product a regulated medical device?
- What does it mean to be regulated?
- If I don’t want to be regulated, can I avoid regulation – and if so, how?
Ideally, we can structure the workshop around attendees actual products and situations. This, of course, will depend on folks registering in advance with sufficient lead time to actually prepare some content around their unique situations. Using participant’s products as case studies should be more engaging and relevant for everyone. If you’re registered for the workshop and want to provide a case study, let me know by completing this contact form.Read More