Medical Connectivity

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The FDA has released its plans for Final and Draft Guidance Documents for fiscal year 2019.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.

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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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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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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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.

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.

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.

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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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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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

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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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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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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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.

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 Single Market for Healthcare in Europe: Learnings for the U.S.

Health Populi

When I asked my longtime colleague and friend Robert Mittman, with whom I collaborated at Institute for the Future for a decade, how he managed international travel and jet lag, he said simply, “The time zone you’re in is the time zone you’re in.”

I Want a New Drug, Part 2 –Digital Therapeutics on the Rise

Digital Health

In the last month I have spoken at an event about digital therapeutics and been invited to speak at 5 more unrelated events on the same topic (note: I am not doing them all).

On World Food Day 2018, Imagine A Chef Cooking for Patients

Health Populi

Today, October 16, is World Food Day. At Health Populi and THINK-Health, we celebrate the birthday of the Food and Agriculture Organization (FAO), allied with the United Nations. FAO was founded to address malnutrition and bolster a sustainable, healthy food supply for people.

Slow Food, Slow Medicine: What Italy Can Teach America About Health

Health Populi

Obesity, diabesity, food deserts and food swamps co-exist across America, factors that cost the U.S. economy over $327 billion a year just in the costs of diagnosed diabetes.

The Importance of Broadband and Net Neutrality for Health, to the Last Person and the Last Mile

Health Populi

California’s Governor Jerry Brown signed into law a net neutrality bill this weekend.

How MedModular Fits Into the New Lower-Cost, High-Quality, Consumer-Enchanted Healthcare World

Health Populi

In American health economics, there’s a demand side and a supply side. On the demand side, we’ve done a poor job trying to nudge patients and consumers toward rational economic decision making, lacking transparency, information symmetry, and basic health literacy.

Going Digital for Health Is a New-Normal for Consumers

Health Populi

Using digital health tech is a new normal for U.S. consumers, including Seniors, found in the 2018 digital health consumer survey from Deloitte. The title of the report, “Consumers are on board with virtual health options,” summarizes the bullish outlook for telehealth.

Social Media and Mental Health – Teenage Wasteland or Land of Opportunity?

Digital Health

Doctors orders: How Ali Parsa plans to make digital health startup Babylon the "Google of Healthcare"

Lloyd Price

For the latest installment of our Big Interview series where we catch up with some of the world’s most exciting business leaders, The Drum makes an appointment with Ali Parsa – founder and chief exec of digital health startup Babylon – to find out about his plans to become the Google of healthcare.

Parexel announces new wearable, mobile tech for clinical trials

Mobi Health News

The biopharmaceutical serivce will launch a new service on Microsoft's Azure App Services that will be able to send care teams patient data alerting them of saftey issues.

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Sicker Consumers Are More Willing to Share Health Data

Health Populi

People dealing with chronic conditions are keener to share personally-generated data than people that don’t have a chronic disease, Deloitte’s 2018 Survey of U.S> > Health Care Consumers learned.

Most U.S. Physicians, Burned Out, Favor A Flavor of Single Payer Health System

Health Populi

Most physicians feel some level of burnout, hassled by electronic health records and lost autonomy.

CVS + Aetna: Inflection Point in US Healthcare, Merger Approved Update

Health Populi

CVS Health’s acquisition of Aetna was approved this week by U.S. Federal regulators after months of scrutinizing the antitrust-size-market control implications of the deal.

Remote Monitoring Devices Are The Future

Duane Boise

Technology is steadily involving and to think that it won’t affect the healthcare industry is an understatement. While many are looking to utilize phone apps to better reach patients, they should also be looking at how to use remote monitoring devices effectively as well.

Retail Tomorrow, Today: A Smart Grocery Cart and Digital Samples For Paleo-Eating Moms

Health Populi

In our Amazon-Primed world, the future of retail is not ten years from now; it’s “tomorrow.”.

AI Can Improve Patient Outcomes, but will Pharma Get there Quickly Enough?

Lloyd Price

No matter what industry you’re in, Artificial Intelligence (AI) is all the rage. It’s the shiniest of the shiny and new, and it’s everywhere.

Consumers Changing the Channel on Where They Shop for Health

Health Populi

Consumers who have long purchased over-the-counter medicines, anti-dandruff shampoo, whitening toothpaste, and cosmetics-with-benefits at food, drug and mass merchant retailers are switching to other places to shop for health, new data from AT Kearney and GMDC have found.

Healthcare connectivity: improving healthcare across the continuum

Mobi Health News

A robust infrastructure is critical to supporting connectivity from inside the hospital to the home

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