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.

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.

227

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.

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The FDA has released its plans for Final and Draft Guidance Documents for fiscal year 2019.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

195

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.

227

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.

EMR 195

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.

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?

HIPAA 195

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. .

195

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.

EHR 195

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.

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.

EMR 195

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.

EMR 195

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.

150

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.

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.

150

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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Industry Voices—Sizing up 4 opportunities for digital transformation in healthcare

FierceHealthIT

According to ISACA’s recently released 2018 Digital Transformation Barometer, some of the most hyped technology also is perceived to hold the highest risk and the highest potential benefit.

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Will robots replace doctors?

KevinMD

Among the many recurring topics, this year has been the impact of machine learning in our lives, especially the implications for our future work life.

Looking across international borders for digital health tools

Mobi Health News

Panelists at the Connected Health Conference in Boston spoke about the importance of digital health alliances and learning from countries sometimes ignored in the space.

The Smartphone Is the Consumer’s Personal Health Platform – Implications from Deloitte’s 2018 Survey

Health Populi

American consumers are now viewing their phones an average of 52 times daily, with 39 percent of consumers believing they use their smartphones too much. In fact, 60 percent of 18 to 34-year-olds admit to smartphone overuse, the highest level of any age group.

Broadband As Social Determinant of Health – Microsoft’s Plan to Bolster Rural Access

Health Populi

In the U.S., the highest levels of unemployment are in places that often have the lowest access to broadband connectivity.

Physicians Don’t Talk Enough with Patients About Non-Medical Needs

Health Populi

Most patients wish their doctors would have a conversation with them about non-medical issues. The Doctor-Patient Conversation , a survey conducted for the Samueli Foundation by the Harris Poll, examined how patients feel about their health, healthcare, and relationships with physicians.

Slow thinking and machine learning in medicine

KevinMD

Recently, several high-profile institutions have called attention to the issue of inclusion and equity when artificial intelligence (AI) algorithms are applied in medicine.

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).

More People Using Meditation and Yoga as Medicine, Especially Women

Health Populi

While overall adoption of meditation and yoga in the U.S. substantially grew between 2012 and 2017, many more women than men use these holistic medicine approaches. In 2017, 14.3% of American adults 18 and over did yoga, 14.2% meditated, and 10.3% saw a chiropractor.

Is your smartphone leading to burnout?

KevinMD

Burnout and dealing with its symptoms has become a hot topic in the last decade. It’s a problem that has multiple contributing factors. Some of those factors are thrust upon us and are beyond our control, such as government regulations.

Millennials want convenient care

KevinMD

The Kaiser Health News article, " Spurred By Convenience, Millennials Often Spurn The ‘Family Doctor’ Model ," caught my eye.

Physicians sacrifice a lot to deliver care. Technology shouldn’t ask for more.

KevinMD

I had a great case the other night. Around midnight on a Friday, the hospitalist physician called me to evaluate an incarcerated femoral hernia. I thought this elderly and medically ill patient would likely die no matter what I did.

The Ultimate Health Outcome, Mortality, Is Rising in America

Health Populi

How long can people living in the U.S. expect to live? years of age, if you were born in 2017. That’s a decline of 0.1 year from 2016. This decline especially impacted baby boys: their life expectancy fell to 76.1 years, while baby girls’ life expectancy stayed even at 81.1 years.

Retail Health Ends 2018 With Big Plans for 2019

Health Populi

As the CVS + Aetna merger crosses its last regulatory hurdle at the close of 2018, we enter 2019 facing a fast-growing and -morphing retail health landscape.

The Growing State of Diabetes in America on World Diabetes Day 2018

Health Populi

Diabetes is a family issue, and its prevalence is growing in America. November 14, 2018, is World Diabetes Day , and the International Diabetes Federation reminds us that this condition impacts the whole household — not just the person diagnosed with diabetes. Why the family?