Are We Over Connected Yet?
Some of us remember when distributed medical devices such as patient monitors had their own dedicated server. That server had one job, to support that manufacturer's medical devices. It was not connected to the enterprise network, in part because there was no network. It did not utilize wireless communication, although there were instances it which it might be susceptible to rogue wireless input. Even the manufacturer could not talk to it remotely. Other functions were not supported by this server. For example, the hospital’s vending machines were on their own.  Only a limited number of people had physical a...
Source: Medical Connectivity Consulting - July 10, 2019 Category: Information Technology Authors: William Hyman Tags: Standards & Regulatory Source Type: blogs

Disrupting Nurse Call
Change is disrupting nurse call. After decades of slow incremental change, the pace of change is quickening. These changes impact provider organizations and manufacturers as nurse call is integrated with adjacent market point of care solutions and new technologies. The benefits will be substantial: improved HCAHPS scores, improved patient safety, shorter length of stay and greater staff productivity. Lagging providers and manufacturers will miss out on the benefits of these new capabilities. Let's look at the recent past of the nurse call market and where we might be going in 2019 and beyond. In this post we'll look at ...
Source: Medical Connectivity Consulting - June 7, 2019 Category: Information Technology Authors: Tim Gee Tags: Nurse Call Strategy & Planning Source Type: blogs

FDA Seeks SaMD PreCert Mock Applicants
FDA has issued a request for SaMD developers to try out the PreCert excellence appraisal process. Since this is a test program the FDA does not intend to actually provide precertification for participating companies. Criteria for those choosing to participate include: Have a plan to submit a De Novo Request or 510(k) submission for a SaMD product prior to June 2020. Be in good standing with the FDA. Agree to follow aspects of the FDA's working model including providing access to certain key performance indicators, collecting real-world postmarket performance data and make it available to the FDA, be available for real-t...
Source: Medical Connectivity Consulting - June 3, 2019 Category: Information Technology Authors: William Hyman Tags: Standards & Regulatory Source Type: blogs

Capsule Tech Acquires Bernoulli Health: Analysis
On April 30, 2019, Capsule Tech announced that it is acquiring Bernoulli Health for an undisclosed amount. This acquisition combines two market leaders in the medical IoT, IoMT, biomedical medical device integration (BMDI), medical device data system (MDDS), medical device connectivity, or whatever you call this market. Medical devices are by far the greatest source of data in health care. For many years the vast majority of medical device data simply scrolled off the screen, never reaching clinicians for analysis and alerting. Capturing this data and using it to better diagnose, treat and monitor patients is finally t...
Source: Medical Connectivity Consulting - May 8, 2019 Category: Information Technology Authors: Tim Gee Tags: Clinical Alarms Clinical Decision Support Company Profiles Connectivity Remote Monitoring Strategy & Planning Surveillance Monitoring Source Type: blogs

Healthcare Messaging & Orchestration — 2019
The objective is to provide a solution that can span tens or hundreds of hospitals in a system, enabling intra-enterprise messaging on a large scale and aggregating data at the enterprise level. Mobile Heartbeat and Spok are moving in this direction. A different but related capability to enterprise scalability is inter-enterprise communications. There is a significant amount of communications between those within a provider organization and external health care trading partners that also care for the patient. These different users include hospital clinicians/caregivers, physician practices, sub acute care, patients, an...
Source: Medical Connectivity Consulting - April 16, 2019 Category: Information Technology Authors: Tim Gee Tags: Company Profiles Messaging & Orchestration Source Type: blogs

Healthcare Messaging & Orchestration — 2019
The objective is to provide a solution that can span tens or hundreds of hospitals in a system, enabling intra-enterprise messaging on a large scale and aggregating data at the enterprise level. Mobile Heartbeat and Spok are moving in this direction. A different but related capability to enterprise scalability is inter-enterprise communications. There is a significant amount of communications between those within a provider organization and external health care trading partners that also care for the patient. These different users include hospital clinicians/caregivers, physician practices, sub acute care, patients, an...
Source: Medical Connectivity Consulting - April 16, 2019 Category: Information Technology Authors: Tim Gee Tags: Company Profiles Messaging & Orchestration Source Type: blogs

FDA on Modifying AI
Recently the FDA released a discussion paper on a Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD). For starters this paper captures several familiar themes. One is that standalone software can be a medical device (SaMD) and therefore subject to FDA regulation. In the Clinical Decision Support space of standalone software this captures systems that are built by machine learning (ML), as opposed to systems that are rule-based, or more algorithmic. One way to appreciate this distinction is that for algorithmic systems the user ca...
Source: Medical Connectivity Consulting - April 9, 2019 Category: Information Technology Authors: William Hyman Tags: Standards & Regulatory Source Type: blogs

Hill-Rom Acquires Voalte: Analysis
Hill-Rom announced March 12, 2019 that it was in the process of acquiring Voalte for $180 million. An additional $15 million earn out was also disclosed. With annual revenue approaching $40M, the enterprise-value to revenue multiple for Voalte is a over 4.5. The acquisition is expected to close during Hill-Rom's third quarter of 2019, which ends June 30th 2019.  Voalte was rumored to be for sale since Q4 of 2018. Voalte Profile Founded by Trey Lauderdale in 2008, Voalte is located in Sarasota, Florida and currently has about 140 employees. Voalte sells perpetual software licenses, services and resells ...
Source: Medical Connectivity Consulting - March 19, 2019 Category: Information Technology Authors: Tim Gee Tags: Company Profiles Messaging & Orchestration Strategy & Planning Source Type: blogs

ONC Finds Possible Merit in FDA Pre-Cert
We have addressed the FDA Pre-Cert program for SaMD (Software as Medical Device) on several occasions. The basic premise of Pre-Cert is that reasonable assurance of low to moderate risk SaMD safety and effectiveness can be achieved by looking at the processes of the vendor/developer rather than looking primarily at the product itself. The Office of the National Coordinator for Health Information Technology (ONC) is part of the Department of Health and Human Services. While Health IT might sound rather expansive, in the ONC context it means record keeping software that receives, sends, and stores health information. This...
Source: Medical Connectivity Consulting - February 25, 2019 Category: Information Technology Authors: William Hyman Tags: Standards & Regulatory Source Type: blogs

Medical Device & IoT Summit
Join us in Boston on February 25-26 to dig deep into medical devices and the Internet of medical things. In this post-EMR world, medical device data is increasingly valuable and continues to evolve. Use cases have moved beyond clinical documentation into the EMR to include near real-time remote surveillance, and the collection of high fidelity medical device data for clinical decision support and training artificial intelligence algorithms. As use cases have evolved, suppliers of all sorts and their related technology have likewise changed considerably over the years. Miniaturization, the consolidation of technologies into...
Source: Medical Connectivity Consulting - January 24, 2019 Category: Information Technology Authors: Tim Gee Tags: Events Source Type: blogs

Another Update to the FDA ’s Pre-Certification Model
The FDA has released a January 2019 update to its working model of the precertification program (Pre-Cert) for software that is a medical device (SaMD). As we have previously addressed (here, here, and here) the idea of the Pre-Cert approach is that a reasonable level of safety can be assured by looking at the developer’s quality system for product development rather than by looking primarily at the product itself.  This “look” involves determining a level of excellence for the developer and matching this level to the risk level of the software. Where appropriate, a streamlined review process wo...
Source: Medical Connectivity Consulting - January 19, 2019 Category: Information Technology Authors: William Hyman Tags: Standards & Regulatory Source Type: blogs

FDA on Software That Isn ’t a Medical Device
The 21st Century Cures Act of 2016 (Cures) had many provisions including defining what kinds of software are medical devices, and some specific kinds of software that are not, and which therefore weren’t subject to FDA regulation. Cures then directed the FDA to look into those that are not and report if they presented a public health problem. The FDA has now released  such a report. Curiously the report is based only on information published after the passage of Cures through July 31, 2018 so that what was known before passage or after the given date is not considered. I would not suggest to any student that the...
Source: Medical Connectivity Consulting - January 2, 2019 Category: Information Technology Authors: William Hyman Tags: Standards & Regulatory Source Type: blogs

FDA to Divide Cybersecurity Risk Into Two Tiers
Medical devices that contain software, or are software, are subject to the well-known medical device classifications of I, II, III, listed in increasing level of risk and correspondingly increasing degree of FDA scrutiny before marketing. In addition to classification, for Software as Medical Device (SaMD) the FDA has suggested, via a Guidance Document (as discussed here), that there are four categories depending on the state of the healthcare situation or condition, and the significance of the information provided by such software to a healthcare decision. In addition to this ranking of the importance of the device, the F...
Source: Medical Connectivity Consulting - November 20, 2018 Category: Information Technology Authors: William Hyman Tags: Standards & Regulatory Source Type: blogs

What You Really Need to Know about Digital Health
You Won't Find This Information in Publications or Vendor Blogs Just where does one draw the boundaries around "digital health?" This will be a discussion unlike those you see in publications or hear at trade shows. We’ll cut through the noise and conventional thinking to key issues regarding what’s needed and what to avoid, in order to be successful in the digital health market. Register Here Join me for a 1-hour conversation with Bridget Moorman about digital health. What does the term digital health mean to us? How have the different levels of technology adoption between the US and EU shaped digit...
Source: Medical Connectivity Consulting - November 17, 2018 Category: Information Technology Authors: Tim Gee Tags: Events Resources Source Type: blogs

Managing Digital Health Regulatory Uncertainty
Uncertainty abounds when managing digital health regulatory uncertainty regarding the FDA and other international regulatory bodies. For this discussion we'll divide uncertainty into two categories, uncertainty due to a lack of knowledge about the potential regulations on the part of manufacturers and uncertainty about just what various regulatory agencies are doing - or going to do - about new and innovative products that meet the definition of a medical device. What is a Medical Device? Let's start with the first category; there is an astounding amount of misinformation and just plain wrong-headedness on the part of many...
Source: Medical Connectivity Consulting - October 24, 2018 Category: Information Technology Authors: Tim Gee Tags: Regulatory Bibliography Standards & Regulatory Source Type: blogs

FDA ’s Guidance Plans for Software in FY 2019
The FDA has released its plans for Final and Draft Guidance Documents for fiscal year 2019.   There are A and B lists for each category in terms of FDA's priority for action. On the A list there are 11 current drafts scheduled for finalization. The drafts of seven of these are from late 2017 with the remainder from 2018. There are 5 drafts on the B list. For new topics for which the FDA is considering developing a draft (as opposed to committed to developing one) the A and B lists have 10 and 2 items respectively, but the B lists have no items directly related to our domain. Of the 11 current drafts on the A list that...
Source: Medical Connectivity Consulting - October 16, 2018 Category: Information Technology Authors: William Hyman Tags: Standards & Regulatory Source Type: blogs

HHS OIG on Cybersecurity and the FDA
The Office of the Inspector General (OIG) of Health and Human Services (HHS) recently released a 25 page report on the FDA's regulatory function in the medical device cybersecurity is domain. The report opens with a rehashing of real and imagined cyber risks, including those reported on by self appointed "white hat" hackers and other vulnerabilities that have not been identified to having actually caused any harm. The FDA's current cybersecurity review process is briefly addressed, which is noted to be based at least in part on its 2014 Guidance on Content of Premarket Submissions for Management of...
Source: Medical Connectivity Consulting - September 22, 2018 Category: Information Technology Authors: William Hyman Tags: Data Security Standards & Regulatory Uncategorized Source Type: blogs

What ’ s So Different About the Health Care Market?
Things your health care product strategy must consider to be successful If you’ve been in health care for any length of time, you know that it is a “different” kind of market, when it comes to health care product strategy. Strategies, tactics and value propositions that would work in any other market tend to stumble in health care — often for unforeseen reasons. We’ve put together a 5-part email series that details why we keep running into these health care market obstacles. Our goal is to provide you with actionable information to better navigate the murky waters of product development  ...
Source: Medical Connectivity Consulting - September 4, 2018 Category: Information Technology Authors: Tim Gee Tags: Resource email series strategy Source Type: blogs

The IoMT Value Hierarchy Webinar
I think it's time that we have this conversation. If data from your medical device ends up in the EMR, then automating that clinical documentation process is now part of the minimal viable product. Sure, innovators and early adopters (less than 20% of the market) may buy without connectivity, but mainstream buyers won't. Luckily, there’s more than one way to accomplish this, and there are additional features and benefits you can deliver with connectivity for competitive advantage. The challenge is figuring out where you fit on the connectivity value hierarchy. Join me on Tuesday, August 14 at 10am Pacific| 1pm E...
Source: Medical Connectivity Consulting - July 27, 2018 Category: Information Technology Authors: Tim Gee Tags: Events Source Type: blogs

10 Changes to the FDA ’ s Pre-Cert Program Model
In June 2018 the FDA released an update to its working model of the Software Pre-Cert Program that addresses 10 areas of comments received as a result of the earlier call for public input. In an usual step, these comment driven changes are clearly identified in the document, rather than leaving it to reader to figure out what is new or different. I will briefly address each of these ten areas. 1. The FDA has reiterated that Pre-Cert can apply to organizations of any size. This isn’t new. 2. The FDA notes that it agrees with the principle that there should be flexibility in the “excellence” appraisals...
Source: Medical Connectivity Consulting - June 25, 2018 Category: Information Technology Authors: William Hyman Tags: Standards & Regulatory Strategy & Planning Source Type: blogs

Continuous Clinical Surveillance: ICU Monitoring Outside the ICU
On Tuesday, June 26, I will interview Brian McAlpine, VP of Strategy and Business Development at Bernoulli Health. Brian and I will discuss continuous clinical surveillance of patients in units such as med-surg, critical care, step-down and telemetry using real-time medical device data. We will also explore the ways technology-assisted clinical surveillance increases safety, lowers costs and offers timely and accurate clinical decision support to identify patients who are developing problems. Register Now Join us for this 1-hour Event and you will learn: What is continuous clinical surveillance, and how (delete-does) it d...
Source: Medical Connectivity Consulting - June 7, 2018 Category: Information Technology Authors: Tim Gee Tags: Interviews Source Type: blogs

Ranking the Importance of SaMD — Software as a Medical Device (UPDATE)
In the May 10th Pre-Cert webinar the FDA addressed an interesting risk matrix that was previously seen in the Software as a Medical Device (SaMD) guidance document, which we discussed here. While a risk matrix involving severity and probability is familiar to many, the SaMD matrix is different in that it addresses the significance of the state of health of the subject of the software and the importance of the information that the  software would provide. There are three levels for health: critical, serious, non-serious. There are also three levels for significance given as Treat or Diagnose, Drive Clinical Manage...
Source: Medical Connectivity Consulting - May 31, 2018 Category: Information Technology Authors: William Hyman Tags: Healthcare IT Standards & Regulatory Source Type: blogs

Ranking the Importance of SaMD — Software as a Medical Device
In the May 10th Pre-Cert webinar the FDA addressed an interesting risk matrix that was previously seen in the Software as a Medical Device (SaMD) guidance document, which we discussed here. While a risk matrix involving severity and probability is familiar to many, the SaMD matrix is different in that it addresses the significance of the state of health of the subject of the software and the importance of the information that the  software would provide. There are three levels for health: critical, serious, non-serious. There are also three levels for significance given as Treat or Diagnose, Drive Clinical Manage...
Source: Medical Connectivity Consulting - May 31, 2018 Category: Information Technology Authors: William Hyman Tags: Healthcare IT Standards & Regulatory Source Type: blogs

Ranking the Importance of SaMD — Software as a Medical Device
In the May 10th Pre-Cert webinar the FDA addressed an interesting risk matrix that was previously seen in the Software as a Medical Device (SaMD) guidance document, which we discussed here. While a risk matrix involving severity and probability is familiar to many, the SaMD matrix is different in that it addresses the significance of the state of health of the subject of the software and the importance of the information that the  software would provide. There are three levels for health: critical, serious, non-serious. There are also three levels for significance given as Treat or Diagnose, Drive Clinical Manage...
Source: Medical Connectivity Consulting - May 31, 2018 Category: Information Technology Authors: William Hyman Tags: Healthcare IT Standards & Regulatory Source Type: blogs

Joint Commission Allows Texting Orders: Now What?
It's safe to say every hospital has a need to text orders to some degree. Now that the Joint Commission has reversed their position stated in a FAQ page in 2011 and said texting orders is now okay (downloadable pdf), where do we go from here? There have always been scenarios where caregivers need new or revised orders to address a patient care issue more quickly than the typical frequency of physician rounding and sitting down to interact with the CPOE system. Common use cases include the need to change alarm parameters to better fit the patient and reduce non-actionable alarms, interventional orde...
Source: Medical Connectivity Consulting - May 17, 2018 Category: Information Technology Authors: Tim Gee Tags: Messaging & Orchestration Source Type: blogs

Real-Time Situational Awareness Discussion with Dr Ben Kanter
Discussion with Dr Ben Kanter appeared first on Medical Connectivity. (Source: Medical Connectivity Consulting)
Source: Medical Connectivity Consulting - May 14, 2018 Category: Information Technology Authors: Tim Gee Tags: Interviews Messaging & Orchestration Source Type: blogs

Real-Time Situational Awareness Discussion with Dr Ben Kanter
Join me for an in-depth discussion with Ben, Kanter, MD, and CMIO of Vocera Communications. This 1-hour event will take place on Monday, May 21st, 2018 at 10:00am Pacific, 1pm Eastern. The topic for this event is situational awareness.  We constantly hear how important this is, especially in dynamic environments where things can change rapidly... like in patient care. What is Situational awareness?  It's the thoughtful consideration people give to factors about a situation or task that dictate what information they and others need, when they need it, and how to prioritize competing demands. It is a recognized &ld...
Source: Medical Connectivity Consulting - May 14, 2018 Category: Information Technology Authors: Tim Gee Tags: Interviews Messaging & Orchestration Source Type: blogs

Messaging Value Pyramid – A Discussion with Ron Remy
Join Ron Remy and me in a discussion of the value pyramid model (pictured below) as it applies to messaging systems for care teams providing enterprise-wide patient care. Register Here Value Pyramid by Ron Remy, CEO, Mobile Heartbeat Ron and I will discuss: Requirements for moving up the value pyramid The shift from point solutions to adopting enterprise-wide communications How messaging adoption can be leveraged for process and workflow re-engineering and quality improvement Aligning customer aspirations with their level of achievement on the value pyramid. During the interview, we will also take questions from those at...
Source: Medical Connectivity Consulting - April 10, 2018 Category: Information Technology Authors: Tim Gee Tags: Interviews Messaging & Orchestration Source Type: blogs

The Inside Story on Wireless in Health Care – A Discussion with David Hoglund
Join me for an in-depth discussion with David Hogland, a long time colleague of mine as we discuss all things wireless in health care. This 1-hour event will take place on Wednesday, March 28, 2018 at 10:00am Pacific, 1pm Eastern. Register Here Our discussion will delve into the following areas: The differences between consumer and enterprise wireless technologies and how they impact usability The use of cellular in hospitals Wireless medical device best practices The best wireless technologies for health care Common wireless mistakes by manufacturers and providers During the interview, we will also take questions from t...
Source: Medical Connectivity Consulting - March 21, 2018 Category: Information Technology Authors: Tim Gee Tags: Interviews Wireless Source Type: blogs

Thoughts on Clinical Decision Support and its Future:  Dr Greenes Interview
In two of my last blog posts, I have interviewed people and companies working in the support and implementation of decision support. With this blog post, I have the honor of interviewing Robert A. Greenes, MD, PhD, one of the first and leading researchers in clinical decision support (CDS) and my former CDS professor. He started as a co-developer of MUMPS in the 1960s while at Harvard Medical School and from there has been and continues to be involved in all aspects of CDS. One of his latest works has been editing and writing chapters for the first and second editions of Clinical Decision Support, ...
Source: Medical Connectivity Consulting - March 14, 2018 Category: Information Technology Authors: Bridget Moorman Tags: Clinical Decision Support Source Type: blogs

Will Pre-Cert Increase the Advantage of Big Companies? (UPDATE)
The impact of FDA's digital health Pre-Cert program has yet to be fully seen. There is much debate about the relative advantages of big vs small companies on the development side of the device/product equation. The classic view is that big has the resources and experience, but perhaps is over constrained and under motivated. Small has entrepreneurial zeal and fewer rules. I once heard that zeal turned into advice to job candidates that you shouldn’t express interest in any hobbies during your interview because they didn’t want people with distractions.  Small may also have no income, but that is a separate...
Source: Medical Connectivity Consulting - March 2, 2018 Category: Information Technology Authors: William Hyman Tags: Mobile Health Standards & Regulatory Source Type: blogs

Will Pre-Cert Increase the Advantage of Big Companies?
There is much debate about the relative advantages of big vs small companies on the development side of the device/product equation. The classic view is that big has the resources and experience, but perhaps is over constrained and undermotivated. Small has entrepreneurial zeal and fewer rules. I once heard that zeal turned into advice to job candidates that you shouldn’t express interest in any hobbies during your interview because they didn’t want people with distractions.  Small may also have no income, but that is a separate matter. However, design/product development is only part of the challenge in m...
Source: Medical Connectivity Consulting - March 2, 2018 Category: Information Technology Authors: William Hyman Tags: Mobile Health Standards & Regulatory Source Type: blogs

Health Care Messaging and Orchestration — Systems of Action (UPDATED)
The objective of a RTHS is providing the right information, at the right time, in the right format, to the right user(s). In a RTHS, systems are designed to sense the need for a change in process, operations or strategy. Gartner attributes the following characteristics to a RTHS: Aware — a RTHS utilizes situational awareness and generates context-sensitive information Adaptive — a RTHS is more proactive (anticipate and predict) than reactive Collaborative — a RTHS uses a conversational user interface to engage clinicians, staff and patients within or across healthcare organizations. Mobile — a RTHS...
Source: Medical Connectivity Consulting - February 12, 2018 Category: Information Technology Authors: Tim Gee Tags: Healthcare IT Messaging & Orchestration Strategy & Planning Emergin Source Type: blogs

Health Care Messaging and Orchestration — Systems of Action
The objective of a RTHS is providing the right information, at the right time, in the right format, to the right user(s). In a RTHS, systems are designed to sense the need for a change in process, operations or strategy. Gartner attributes the following characteristics to a RTHS: Aware — a RTHS utilizes situational awareness and generates context-sensitive information Adaptive — a RTHS is more proactive (anticipate and predict) than reactive Collaborative — a RTHS uses a conversational user interface to engage clinicians, staff and patients within or across healthcare organizations. Mobile — a RTHS...
Source: Medical Connectivity Consulting - February 12, 2018 Category: Information Technology Authors: Tim Gee Tags: Healthcare IT Messaging & Orchestration Messaging Middleware Strategy & Planning Emergin Source Type: blogs

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 ov...
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 ...
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 spec...
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 particu...
Source: Medical Connectivity Consulting - November 14, 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 ...
Source: Medical Connectivity Consulting - November 14, 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. ...
Source: Medical Connectivity Consulting - October 20, 2017 Category: Information Technology Authors: William Hyman Tags: Data Security Source Type: blogs

Having Problems with Your Emergin System?
Years ago, many hospitals bought an Emergin messaging middleware system as a point solution to bring messaging to specific interfaced systems. Many of these were used to get event data out of nursecall and other systems that was communicated to caregivers or some other point of care use case. These point solutions were installed in closets or data centers and not given much more thought. Inevitably, something changes in the systems connected to Emergin and an interface breaks. Getting help with these problems can turn out to be rather difficult. If your problem was caused by an update to the system interfaced with Emergin,...
Source: Medical Connectivity Consulting - October 16, 2017 Category: Information Technology Authors: Tim Gee Tags: Messaging Middleware Nurse Call Emergin Emergin repair Emergin service Emergin upgrade Source Type: blogs