Call for Contributing Authors
Today I was contacted by a social media marketing firm working for a major MDDS vendor with an offer to contribute content that’s on topic for this site (that last part is important). I’m interested, and I imagine a lot of this blog’s readers will be too. As I will likely take them up on their offer, I want everyone to understand that there’s not any favoritism that plays into who gets to post on this site. So, the following describes the ground rules, the benefits of contributing, and issues an open invitation to contribute posts.
We’ve been fortunate to have a number of terrific contributing authors over the years, and some of them have written posts that continue to be popular to this day. On the About This Site page is a long standing open invitation to anyone who wants to climb up on the soap box and spout off contribute to the conversation about medical device connectivity. I’ve also made contributing author offers personally to many folks on both the provider and vendor sides of the table. There are so many people who have incredible knowledge and experience to share. And most of these people don’t have the time or inclination to create their own blog. Now you have an outlet.
Hacked Insulin Pump
The fact that connectivity, and perhaps wireless connectivity in particular, allows for hacking for mischief, theft, politics, social protest and other forms and varying degrees of evil should surely come as no surprise. In turn, that a wireless medical device might be hackable should be somewhere on the mind of developers, users, and regulators. Thus the report from the recent Black Hat conference that someone hacked an insulin infusion pump, and in so doing was then able to alter its settings, should also not be particularly shocking, but should serve as yet another reminder, that security associated with connectivity has been and continues to be an issue, as was addressed by Tim back in 2006.
The report in this instance came from Jay Radcliffe who hacked his own insulin delivery equipment. In this instance the hacking avenue was the wireless remote that was part of the device. Perhaps the idea that a wireless remote could be emulated is even at the ultra low end of surprise. More generally, the multiple discussions of this report (e.g. here and here) have suggested that the technology being used by at least some medical device manufacturers does not offer an adequate array of security safeguards. Or the manufacturers haven’t fully utilized what is available in terms of alternate hardware, or they havn’t fully utilized the security features that were available even in the hardware that they were using.
Third Medical Device Connectivity Conference
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.
