HIMSS18 Planning
What makes the annual HIMSS meeting special?  Many vendors release new products or make important announcements at HIMSS. Of the huge number of exhibitors, vendors bring more than sales reps to attend HIMSS. This is a great opportunity to have meaningful conversations with product managers, engineers and a variety of company executives to discuss detailed product and implementation questions, product roadmaps and connectivity with other vendor's systems. Perhaps the biggest advantage of HIMSS is that you can do this across numerous vendors, looking at both competitors and potential vendor collaborators in a broader overal...
Source: Medical Connectivity Consulting - February 7, 2018 Category: Information Technology Authors: Tim Gee Tags: Events HIMSS18 las vegas Source Type: blogs

Medical Device Security: a Simple Roadmap and What to Do Right Now
Join us for an in-depth discussion with Caston Thomas, an expert in the field of data security with an emphasis helping hospitals secure and manage their medical devices, networks and IT assets. This event will be on February 21, 2018 at 1pm Eastern, 10am Pacific time. Register Here Our discussion will delve into the following areas: How medical device security differs from IT security, and how to make the best use of the skills sets in both departments Building a framework for locking down medical devices and addressing the challenges that have inhibited our progress until now How we improve governance in IT and biomedic...
Source: Medical Connectivity Consulting - January 31, 2018 Category: Information Technology Authors: Tim Gee Tags: Data Security Interviews Source Type: blogs

Medical Device Data Security: Caston Thomas Tells Us What to Do Right Now
Join us for an in-depth live interview with the Chuck Norris of data security, Caston Thomas. This event will be on February 14, 20018 at 3pm Eastern, noon Pacific time. Our discussion will delve into the following areas: Defining the medical device data security challenge in realistic terms Changes required in IT and biomedical engineering governance to improve medical device data security Explore the various technology solutions available for medical device data security, and Delve into how data security for medical devices is different than your typical IT data security During the interview, Caston will also take...
Source: Medical Connectivity Consulting - January 31, 2018 Category: Information Technology Authors: Tim Gee Tags: Data Security Interviews Source Type: blogs

Medical Device Security Threat Predictions for 2018
Last November Kapersky Labs made some medical device security predictions for 2018 on their SecureList security bulletin. Kapersky has forgotten more about security than I know, but my understanding of health care and the medical device world allows me to offer some perspective and corrections to Kapersky's predictions. Let's review the relevant predictions: Attacks targeting medical equipment with the aim of extortion, malicious disruption or worse, will rise. The volume of specialist medical equipment connected to computer networks is increasing.  Many such networks are private, but one external Internet connection can ...
Source: Medical Connectivity Consulting - January 8, 2018 Category: Information Technology Authors: Tim Gee Tags: Data Security cybercriminal cybersecurity ransomware Source Type: blogs

FDA Busy With Software
Since connectivity runs on software, and some medically related software is a medical device, and medical devices are regulated by the FDA, those involved in connectology must pay at least some attention to what the FDA is saying about the subject of medical software that is not an inherent part of some other medical device.  In this regard the FDA speaks in multiple ways, ranging from regulations, to final guidance documents (fGD), to draft guidance documents (dDG), to more casual public comments. Recently (since October 1st) the FDA has been busy in the software space by releasing several new fGDs and dGDs that specific...
Source: Medical Connectivity Consulting - December 20, 2017 Category: Information Technology Authors: William Hyman Tags: Standards & Regulatory Source Type: blogs

Data Driven Predictive Medical Devices: An Interview
In 1987, James Gleick wrote the book Chaos which was a layman’s description of different instances where chaotic behavior was displayed in systems. In one of the last chapters titled Inner Rhythms, he described the then latest research regarding physiological system characteristics and the seemingly oxymoronic idea that variable response of the system indicated health versus illness, specifically with regard to heart rate variability, and that these systems exhibited characteristics of nonlinear dynamics in which physiologists ‘began to see chaos as health.’ That book, which I read in 1988, and in particular that cha...
Source: Medical Connectivity Consulting - November 13, 2017 Category: Information Technology Authors: Bridget Moorman Tags: Clinical Decision Support Interviews Source Type: blogs

FDA Guidance on Software Changes
On October 25, 2017 the FDA released its guidance on "Deciding When to Submit a 510(k) for a Software Change to an Existing Device". A draft of this guidance was released in August 2016 and I commented on that draft here. The scope of what was changed is not easy to discern, especially since the draft is no longer directly available and the URL for the final guidance is the same as that for the previous draft. No doubt there are many people who have a copy of the draft and the Wayback Machine might also be explored. But such a comparison might be moot anyway with respect to what the FDA is now telling us it expects manufa...
Source: Medical Connectivity Consulting - November 13, 2017 Category: Information Technology Authors: William Hyman Tags: Standards & Regulatory Source Type: blogs

Healthcare Messaging Conference – Special Limited Time Pricing
Early-bird pricing lasts until October 31 Receive an extra $100 off your registration fee with the discount code '79' Offer lasts until October 31 Click here to get this special pricing! 20+ Speakers Here are just some of the speakers on the program that includes clinicians, IT professionals and vendor executives. Their presentations will provide insight into best practices, lessons learned and how messaging solutions are evolving. And there are another handful of speakers being being added to the agenda this week and next. Be sure to check for additions...
Source: Medical Connectivity Consulting - October 25, 2017 Category: Information Technology Authors: Tim Gee Tags: Events Messaging Middleware Source Type: blogs

Healthcare Messaging Conference – Special Limited Time Pricing
Early-bird pricing lasts until October 31 Receive an extra $100 off your registration fee with the discount code '79' Offer lasts until October 31 Click here to get this special pricing! 20+ Speakers Here are just some of the speakers on the program that includes clinicians, IT professionals and vendor executives. Their presentations will provide insight into best practices, lessons learned and how messaging solutions are evolving. And there are another handful of speakers being being added to the agenda this week and next. Be sure to check for additions...
Source: Medical Connectivity Consulting - October 25, 2017 Category: Information Technology Authors: Tim Gee Tags: Events Messaging Middleware Source Type: blogs

Even More Proposed Medical Device Connectivity Legislation
The FDA, medical devices, and cybersecurity are popular subject matter for proposed Federal legislation, even though most bills in this arena never clear committee. One wonders sometimes if those introducing such bills really care about them being enacted, or are they just an exercise in publicity and perhaps self-aggrandizement. On October 5, 2017 H.R. 3985: Internet of Medical Things Resilience Partnership Act of 2017 was introduced by Dave Trott of Michigan and Susan Brooks of Indiana.  In addition to possible self-aggrandizement, in the present case the bill also celebrates National Cybersecurity Month. If you haven...
Source: Medical Connectivity Consulting - October 20, 2017 Category: Information Technology Authors: William Hyman Tags: Data Security Source Type: blogs