Medical Connectivity

Managing Digital Health Regulatory Uncertainty

Medical Connectivity

Uncertainty abounds when managing digital health regulatory uncertainty regarding the FDA and other international regulatory bodies.

Capsule Tech Acquires Bernoulli Health: Analysis

Medical Connectivity

On April 30, 2019, Capsule Tech announced that it is acquiring Bernoulli Health for an undisclosed amount.

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Disrupting Nurse Call

Medical Connectivity

Nurse call is changing. 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.

FDA Seeks SaMD PreCert Mock Applicants

Medical Connectivity

FDA has issued a reques t 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.

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FDA on Modifying AI

Medical Connectivity

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.

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FDA on Software That Isn’t a Medical Device

Medical Connectivity

The 21 st 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.

Healthcare Messaging & Orchestration — 2019

Medical Connectivity

Messaging is all about getting things done. Whether you call it Secure Texting, Secure Messaging, Clinical Communications and Collaboration, Messaging and Orchestration, Workflow Automation or something else, we're talking about the ability to message users to accomplish a specific task who are mobile or at a desk using a conversational user interface. In this post we'll look at how health care messaging and orchestration solutions are changing for 2019.

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Medical Device & IoT Summit

Medical Connectivity

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.

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ONC Finds Possible Merit in FDA Pre-Cert

Medical Connectivity

We have addressed the FDA Pre-Cert program for SaMD (Software as Medical Device) on several occasions.

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FDA to Divide Cybersecurity Risk Into Two Tiers

Medical Connectivity

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.

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Another Update to the FDA’s Pre-Certification Model

Medical Connectivity

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).

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What You Really Need to Know about Digital Health

Medical Connectivity

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.

Healthcare Messaging & Orchestration — 2019

Medical Connectivity

Messaging is all about getting things done. Whether you call it Secure Texting, Secure Messaging, Clinical Communications and Collaboration, Messaging and Orchestration, Workflow Automation or something else, we're talking about the ability to message users to accomplish a specific task who are mobile or at a desk using a conversational user interface. In this post we'll look at how health care messaging and orchestration solutions are changing for 2019.

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Thoughts on Clinical Decision Support and its Future: Dr Greenes Interview

Medical Connectivity

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.

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Real-Time Situational Awareness Discussion with Dr Ben Kanter

Medical Connectivity

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.

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FDA’s Guidance Plans for Software in FY 2019

Medical Connectivity

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.

Medical Device Security Threat Predictions for 2018

Medical Connectivity

Last November Kapersky Labs made some medical device security predictions for 2018 on their SecureList security bulletin.

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Data Driven Predictive Medical Devices: An Interview

Medical Connectivity

In 1987, James Gleick wrote the book Chaos which was a layman’s description of different instances where chaotic behavior was displayed in systems.

HHS OIG on Cybersecurity and the FDA

Medical Connectivity

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.

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The IoMT Value Hierarchy Webinar

Medical Connectivity

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.

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Ranking the Importance of SaMD — Software as a Medical Device

Medical Connectivity

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.

Ranking the Importance of SaMD — Software as a Medical Device

Medical Connectivity

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.

Joint Commission Allows Texting Orders: Now What?

Medical Connectivity

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?

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Real-Time Situational Awareness Discussion with Dr Ben Kanter

Medical Connectivity

If you're reading this, you missed our in-depth discussion with Ben, Kanter, MD , and CMIO of Vocera Communications. Click the button below to watch the replay. You can submit questions to Dr Kanter or myself via the question form on the replay page. .

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Messaging Value Pyramid – A Discussion with Ron Remy

Medical Connectivity

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. Value Pyramid by Ron Remy, CEO, Mobile Heartbeat. Ron and I will discuss: Requirements for moving up the value pyramid.

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Will Pre-Cert Increase the Advantage of Big Companies? (UPDATE)

Medical Connectivity

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.

Will Pre-Cert Increase the Advantage of Big Companies?

Medical Connectivity

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.

Health Care Messaging and Orchestration — Systems of Action

Medical Connectivity

In this post we will delve into a growing enterprise software category, consider the underlying technology, and explore the ways this technology is being developed and applied in health care. System of Action.

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HIMSS18 Planning

Medical Connectivity

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.

Medical Device Security: a Simple Roadmap and What to Do Right Now

Medical Connectivity

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.

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FDA Busy With Software

Medical Connectivity

FDA Guidance on Software Changes

Medical Connectivity

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.

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Healthcare Messaging Conference – Special Limited Time Pricing

Medical Connectivity

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.

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Even More Proposed Medical Device Connectivity Legislation

Medical Connectivity

The FDA, medical devices, and cybersecurity are popular subject matter for proposed Federal legislation, even though most bills in this arena never clear committee.

Having Problems with Your Emergin System?

Medical Connectivity

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.

What’s So Different About the Health Care Market?

Medical Connectivity

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.

10 Changes to the FDA’s Pre-Cert Program Model

Medical Connectivity

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. The FDA has reiterated that Pre-Cert can apply to organizations of any size. This isn’t new.

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Continuous Clinical Surveillance: ICU Monitoring Outside the ICU

Medical Connectivity

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.

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The Inside Story on Wireless in Health Care – A Discussion with David Hoglund

Medical Connectivity

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.

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The Most Important Trends For Health in Mary Meeker’s 2019 Internet Report Aren’t About Health Care

Health Populi

The health care section of Mary Meeker’s 334-page annual report, Internet Trends 2019 , comprises 24 of those pages (270 through 293).