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ONC & CMS Proposed Rules – Part 3: Data Requirements

Matt Humphrey
Dave Levin

By DAVE LEVIN, MD and MATT HUMPHREY

The Office of the National Coordinator (ONC) and the Centers for Medicare and Medicaid (CMS) have proposed final rules on interoperability, data blocking and other activities as part of implementing the 21st Century Cures Act. In this series, we will explore the ideas behind the rules, why they are necessary and the expected impact. Given that these are complex and controversial topics open to interpretation, we invite readers to respond with their own ideas, corrections and opinions. In part three of this series, we look at how the new USCDI draft helps foster innovation.  

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The U.S. Core Data for Interoperability (USCDI) draft is a step forward toward expanding the 21st Century Cures Act. The Cures Act was helpful in moving the needle for interoperability and defining data blocking. The latest draft of the USCDI is meant to further specify what data should be shared freely.

In this article, we’ll look at the data added to the Common Clinical Data Set (CCDS) used for ONC certification. We’ll walk through the proposed plan to add more data over time. And we’ll explore why this is a step in the right direction toward increased data sharing.

New Shared Data

The bulk of the datasets in the USCDI comes from the Common Clinical Data Set (CCDS), which was last updated in 2015. The new USCDI draft adds two types of data:

  • Clinical notes: both structured and unstructured. EHRs store these notes differently, but both are important and helpful in data analysis.
  • Provenance:  an audit trail of the data, showing where it came from. It is metadata, or information about the data, that shows who created it and when.

The Fast Healthcare Interoperability Resources (FHIR) have created standards around APIs used to access health care data. APIs developed under the FHIR standard aligns with the USCDI to meet the proposed certification rules. The USCDI draft recommends using a FHIR compliant API to access the data.

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Will Digital Therapeutics be ‘The End’ of Digital Health? | Eugene Borukhovich, G4A Bayer

By JESSICA DAMASSA, WTF HEALTH

How are ‘digital therapeutics’ different than what we’ve already been doing in ‘digital health’? Eugene Borukhovich, Global Head of Digital Health for Bayer, talks about how he thinks eventually the term ‘digital health’ will just disappear. What’s behind this prediction? Listen in to find out.

Filmed at JP Morgan Healthcare Conference, San Francisco, January 2019.

Jessica DaMassa is the host of the WTF Health show & stars in Health in 2 Point 00 with Matthew Holt.

Get a glimpse of the future of healthcare by meeting the people who are going to change it. Find more WTF Health interviews here or check out www.wtf.health

Investment State-of-Play in Big Pharma: Bayer’s Eugene Borukhovich Weighs In

By JESSICA DaMASSA, WTF HEALTH

Bayer’s G4A team launched their 2019 program today, so here’s a little help for anyone curious about the state of pharma startup investment and what it takes to land a deal there these days.

I had the chance to pick the brain of Bayer’s Global Head of Digital Health, Eugene Borukhovich, during JP Morgan Healthcare Week and pulled out these three gloriously thought-provoking soundbites from our conversation to give you some insight as to the mindset over at big Bayer.

  • “Digital therapeutics are shining light on the convoluted, complex mess of digital health”

If you’ve wondered what lies ‘beyond the pill’ for Big Pharma, wonder no more. It seems the answer is digital therapeutics. Eugene predicts that “within the next couple of years, ‘digital health’ as a term will disappear,” and calls out organizations like the Digital Therapeutics Alliance for their efforts to set standards around evidence-base and behavior modification so regulators and strategic investors alike can properly evaluate claims made by health tech startups. As time goes on, it looks like efforts to ‘pharma-lize’ the ways startups take their solutions to market will increase, pushing them into more traditional go-to-market pathways that have familiar and comforting guidelines in place. As Eugene says, “Ultimately, what we say in my team, is that it’s about health in a digital world today.” Sounds like that’s true for both the products he’s seeking AND the way pharma is looking to bring them to market… 

  • “These multi-hundred million [dollar] press releases are great to a certain extent, but what happened to the start-up style mentality?”

When asked about Big Tech getting into Big Health, in the end, it seems, Eugene shakes out to be in favor of the ‘Little Guy’ – or, at least, in their approach. Don’t miss his comments about “cockiness in our healthcare industry” and how Big Tech is working around that by partnering up, but the salient point for startups is that big companies still seem very much interested in buddying with smaller businesses. It’s for all the same reasons as before: agility, the ability to iterate quickly, and the opportunity to do so within reasonable budgets. Eugene offered this telling rhetorical musing: “Just because it’s a combination of two big giants…do you need to do $500 million? Or, do you give some…traction, milestone, [etc.]…to prove it, just like a start-up would?”

  • “In large organizations, transformation equals time, and…we don’t have time.”

“To me,” says Eugene, “the biggest challenge is actually landing these inside the organization.” He’s talking about novel health solutions – digital therapeutics or otherwise – after learning from previous G4A cycles. Culture, precedent, and years of market success loom large in big healthcare companies across the ecosystem, which is one reason why innovation inside them is so challenging. Eugene says he’s “a big believer in a small team – even in large organizations – to take something by the cojones, and get shit done, and move it forward, and push the envelope from the bureaucracy and the process.” There’s a sense of urgency to ‘innovate or die’ in the face of the growing competition in the healthcare industry. “Back to this earlier conversation around whether it’s tech giants or other companies,” he adds, “it is a race to the speed of the organization. How quickly we learn and how quickly we make the decisions. Bottom line, that’s it.”

There’s plenty more great insights and trend predictions where these came from, plus the juicy details behind how G4A itself has pivoted this year. Check out the full interview now.

A Mental Health Chatbot that Can Reduce Symptoms of Depression by 13-18% | Michiel Rauws of X2AI

Mental health chatbot startup, X2AI, uses a text-based chatbot to respond to people experiencing depression, addiction, and thoughts of suicide via customized text conversations. More than 4 million people have paid access to the service, which has been shown to reduce symptoms of depression by 13-18%. Founder Michiel Rauws talks about how machine learning helped develop the bot (called Tess) and what’s on tap next for his company.

Filmed at the JP Morgan Healthcare Conference in San Francisco, CA, January 2019.

Jessica DaMassa is the host of the WTF Health show & stars in Health in 2 Point 00 with Matthew Holt.

Get a glimpse of the future of healthcare by meeting the people who are going to change it. Find more WTF Health interviews here or check out www.wtf.health


The Neobiological Revolution | Jane Metcalfe, CEO NEO.LIFE & Founder Wired Magazine

By JESSICA DAMASSA, WTF HEALTH

Jane Metcalfe founded Wired Magazine 25 years ago to talk about the tech revolution. Today, her new publication, NEO.LIFE is reporting from the the front lines of the “Neobiological Revolution.” From the most astounding developments in neuroscience, genome sequencing, and longevity to biohacking, synthetic biology, fertility, and human performance, NEO.LIFE covers the bleeding edge of health innovation. From that vantage point, we got Jane to weigh in on all the big questions…like how is today’s health tech scene reminiscent of the burgeoning tech scene of the 90’s? And, of course, why the f%$! are there still fax machines in hospitals?!

Jessica DaMassa is the host of the WTF Health show & stars in Health in 2 Point 00 with Matthew Holt.

Get a glimpse of the future of healthcare by meeting the people who are going to change it. Find more WTF Health interviews here or check out www.wtf.health

Teladoc, CVS, Utilization Rates, & Apple in ‘THE YEAR of Telehealth’

By JESSICA DA MASSA, WTF Health

According to Toby Cosgrove, 2019 is “THE YEAR of telehealth.” The former CEO of Cleveland Clinic, who is currently an executive advisor to Google Cloud’s healthcare and life sciences team, proclaimed it as such to CNBC, saying that this year is “THE YEAR” telehealth becomes ubiquitous.

That’s a pretty bold statement – particularly as utilization rates for virtual visits continue to fall short of expectations – so we double-checked this prognostication with Teladoc’s CEO, Jason Gorevic.

Does he think 2019 is going to be telehealth’s turning point?

Well, although he’d rather call the space ‘virtual care’ instead of ‘telehealth’ (maybe this will be the difference maker?), he confesses he’s pretty much on board with Cosgrove’s assertion that more consumers than ever will visit virtual exam rooms this year.

But, why?

How does 2019 become “THE YEAR” of virtual care? Is this going to be an industry-wide boon, or is Teladoc just banking on its partnership with CVS and their new family member, Aetna?

Tune in to hear Jason get real about what’s impacting utilization rates, how things are going to change this year, AND whether or not he’s worried about competing with Apple, Google, and Amazon for screen time. (Hint: He’s not.)

ONC & CMS Proposed Rules | Part 2: Interoperability

Dave Levin

By DAVE LEVIN MD 

The Office of the National Coordinator (ONC) and the Centers for Medicare and Medicaid (CMS) have proposed final rules on interoperability, data blocking and other activities as part of implementing the 21st Century Cures Act. In this series, we will explore the ideas behind the rules, why they are necessary and the expected impact. Given that these are complex and controversial topics open to interpretation, we invite readers to respond with their own ideas, corrections and opinions. You can find Part 1 of the series here

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In 2016, Congress enacted the 21st Century Cures Act with specific goals to “advance interoperability and support the access, exchange and use of electronic health information.” The purpose was to spur innovation and competition in health IT while ensuring patients and providers have ready access to the information and applications they need.

The free flow of data and the ability for applications to connect and exchange it “without special effort” are central to and supported by a combination of rules proposed by ONC and CMS. These rules address both technical requirements and expected behaviors. In this article, we look at specific technical and behavioral requirements for interoperability. Future articles will examine data blocking and other behavioral issues.

Compatible “Plugs and Sockets”

The proposed rules explicitly mandate the adoption and use of application programming interface (API) technology (or a successor) for a simple reason: APIs have achieved powerful, scalable and efficient interoperability across much of the digital economy. Put simply, APIs provide compatible “plugs and sockets” that make it easy for different applications to connect, exchange data and collaborate. They are an essential foundation for building the next generation of health IT applications. (Note: readers who want to go deeper into APIs can do so at the API Learning Center).

APIs are versatile and flexible. This makes them powerful but can also lead to wide variations in how they work. Therefore, ONC is proposing that certified health IT applications use a specific API based on the Fast Healthcare Interoperability Resources (FHIR) specification. FHIR is a consensus standard developed and maintained by the standards development organization (SDO) Health Level–7 (HL7). Mandating the use of the FHIR standard API helps to ensure a foundational compatibility and basic interoperability. This gives API technology suppliers (like EHR vendors) a clear set of standards to follow in order to fulfill the API requirement. It also ensures “consumers” of that API (like hospitals and health IT developers), have consistency when integrating applications.

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Health in 2 Point 00, Episode 73 | Mergers, Medicaid, & Money

Today on Health in 2 Point 00, Jess and I power through a whopping six questions. In this episode, Jess asks me about the merger between Cambia Health Solutions and Blue Cross NC, Alex Azar getting grilled by Rep. Joe Kennedy on Medicaid work requirements, Omada Health adding connected blood pressure and glucose monitors, 23andMe’s new Type 2 Diabetes predisposition test, and raises by Akili Interactive and MAP Health Management. —Matthew Holt 

Health Care Price Tags Won’t Find You the Best Doctor

By MICHAEL L. MILLENSON

Say you want to know which baseball players provide the most value for the big dollars they’re being paid. A Google search quickly yields analytics. But suppose your primary care physician just diagnosed you with cancer. What will a search for a “high value” cancer doctor tell you?

Not much.

Public concern over bloated and unintelligible medical bills has prompted pushback ranging from an exposé by a satirical TV show to a government edict that hospitals list their prices online. But despite widespread agreement about the importance of high-value care, information about the clinical outcomes of individual physicians, which can put cost into perspective, is scarce. Even when information about quality of care is available, it’s often unreliable, outdated, or limited in scope.

For those who are sick and scared, posting health care price tags isn’t good enough. The glaring information gap about the quality of care must be eliminated.

“When people are comparison shopping, knowing the price of something is not enough,” notes Eric Schneider, a primary care physician and senior vice president of policy and research at the Commonwealth Fund. “People want to know the quality of the goods and services they’re buying.”

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Reducing Burnout and Increasing Efficiency with Telepsychiatry

SPONSORED POST

By PETER YELLOWLEES MD 

Telepsychiatry is now an established form of mental health care. Many studies demonstrate that it meets all appropriate standards of psychiatric care and may be better than in-person consultations for certain groups of patients, such as children, adults with PTSD or anxiety disorders, or those who find it hard to leave their homes. At UC Davis all patients are now offered the option of either seeing their psychiatrist in person, online at home, or in any private setting. Many patients now choose to receive their care in a hybrid manner that can be significantly better than being seen exclusively in the clinic office for numerous reasons.

From the patient’s perspective it is more convenient, allowing them to fit their consultations into their lives, rather than having to take several hours out to travel and attend a clinic. Many patients also find this form of care to be more intimate and less threatening, with the slightly increased “distance” from the therapist allowing them to feel safer talking about stigmatized or embarrassing topics, such as trauma and abuse. We also know from numerous satisfaction studies that patients like being treated using video. In fact some groups, such as children and young adults, prefer this to conventional methods.

What has not been examined scientifically in as much detail is the impact telepsychiatry has on providers, although the latter are voting with their feet. Latest figures suggest that up to 15% of psychiatrists are now using video with their patients  There are numerous advantages for psychiatrists and it is becoming clear that treating patients in a hybrid manner using telepsychiatry, as well as other technologies like messaging and secure email, may be a major response to the problem of physician burnout, making providers both more efficient and clinically effective.

So what are the advantages of telemedicine for mental health providers?

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