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Tag: Interoperability

Patient-Directed Access for Competition to Bend the Cost Curve

By ADRIAN GROPPER, MD

Many of you have received the email: Microsoft HealthVault is shutting down. By some accounts, Microsoft has spent over $1 Billion on a valiant attempt to create a patient-centered health information system. They were not greedy. They adopted standards that I worked on for about a decade. They generously funded non-profit Patient Privacy Rights to create an innovative privacy policy in a green field situation. They invited trusted patient surrogates like the American Heart Association to participate in the launch. They stuck with it for almost a dozen years. They failed. The broken market and promise of HITECH is to blame and now a new administration has the opportunity and the tools to avoid the rent-seekers’ trap.

The 2016 21st Century CURES Act is the law. It is built around two phrases: “information blocking” and “without special effort” that give the administration tremendous power to regulate anti-competitive behavior in the health information sector. The resulting draft regulation, February’s Notice of Proposed Rulemaking (NPRM) is a breakthrough attempt to bend the healthcare cost curve through patient empowerment and competition. It could be the last best chance to avoid a $6 Trillion, 20% of GDP future without introducing strict price controls.

This post highlights patient-directed access as the essential pro-competition aspect of the NPRM which allows the patient’s data to follow the patient to any service, any physician, any caregiver, anywhere in the country or in the world.

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ONC & CMS Proposed Rules – Part 4: Information Blocking

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 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.

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When it comes to sharing health data, the intent of the 21st Century Cures Act is clear: patients and clinicians should have access to data without special effort or excessive cost. To make this a reality, the act addresses three major areas: technical architecture, data sets and behaviors. Part two of our series looked at how APIs address technical issues while part three covered the new data requirements. In this article, we delve into information blocking. A companion podcast interview with ONC expert Michael Lipinski provides an even deeper dive into this complex topic.

Information Blocking Comes in Many Forms

The Public Health Services Act (PHSA) broadly defines information blocking as a practice that is “likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information.” The overarching assumption is information will be shared though the Act does authorize the Secretary to identify reasonable and necessary exceptions.

The proposed rules focus on “technical requirements as well as the actions and practices of health IT developers in implementing the certified API.” Information blocking can come in a variety of forms. It can be direct and obvious (“No you can’t have this data ever!”) or indirect and subtle (“Sure, you can have the data, but it will cost you $$$ and we won’t be able to get to your request for at least 12 months.”). The proposed rules are designed to address both. This passage illustrates some of the concerns:

“Health IT developers are in a unique position to block the export and portability of data for use in competing systems or applications, or to charge rents for access to the basic technical information needed to facilitate the conversion or migration of data for these purposes.”

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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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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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Interoperability and Data Blocking | Part 1: Fostering Innovation

By DAVE LEVIN MD 

The Office of the National Coordinator (ONC) and the Centers for Medicare and Medicaid (CMS) have published proposed final rules on interoperability and data blocking 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, controversial topics, and open to interpretation, we invite readers to respond with their own ideas, corrections, and opinions.

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Health IT 1.0, the basic digitalization of health care, succeeded in getting health care to stop using pens and start using keyboards. Now, Health IT 2.0 is emerging and will build on this foundation by providing better, more diverse applications. Health care is following the example set by the rest of the modern digital economy and starting to leverage existing monolithic applications like electronic health records (EHRs) to create platforms that support a robust application ecosystem. Think “App Store” for healthcare and you can see where we are headed.

This is why interoperability and data blocking are two of the biggest issues in health IT today. Interoperability – the ability of applications to connect to the health IT ecosystem, exchange data and collaborate – is a key driver of the pace and breadth of innovation. Free flowing, rich clinical data sets are essential to building powerful, user-friendly applications.  Making it easy to install or switch applications reduces the cost of deployment and fosters healthy competition. Conversely, when data exchange is restricted (data blocking) or integration is difficult, innovation is stifled.

Given the importance of health IT in enabling the larger transformation of our health system, the stakes could hardly be higher. Congress recognized this when it passed the 21st Century Cures Act in 2016. Title IV of the act contains specific provisions designed to “advance interoperability and support the access, exchange, and use of electronic health information; and address occurrences of information blocking”. In February 2019, ONC and CMS simultaneously published proposed rules to implement these provisions.

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EMR Integration Done Better, Cheaper, & Faster…Again? | Sansoro Health CEO Jeremy Pierotti

By JESSICA DaMASSA, WTF Health

Sansoro Health is a next-gen EHR integration platform for Health IT companies that need a better, cheaper, and faster way to integrate their products into EMR systems. What sets them apart in this crowded space? Listen in to hear co-founder and CEO Jeremy Pierotti paint a picture of perfect-world of interoperability.

Filmed at HIMSS 2019 in Orlando, Florida, February 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 End of the ‘Interoperability Showcase?’ | Niko Skievaski, Redox

By JESSICA DAMASSA, WTF HEALTH

Will there be a future that DOESN’T include an Interoperability Showcase at HIMSS because interoperability will be solved?? Redox Co-Founder & CEO Niko Skievaski gives us his analysis of how market forces, value-based care, and policy like the HHS ONC & CMS rules for APIs and data sharing are starting to right the ‘market failure’ of health systems being unable to share their data.

Filmed at HIMSS 2019 in Orlando, Florida, February 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 Futility of Patient Matching

By ADRIAN GROPPER, MD

The original sin of health records interoperability was the loss of consent in HIPAA. In 2000, when HIPAA (Health Insurance Portability and Accountability Act) first became law, the Internet was hardly a thing in healthcare. The Nationwide Health Information Network (NHIN) was not a thing until 2004. 2009 brought us the HITECH Act and Meaningful Use and 2016 brought the 21st Century Cures Act with “information blocking” as clear evidence of bipartisan frustration. Cures,  in 2018, begat TEFCA, the draft Trusted Exchange Framework and Common Agreement. The next update to the draft TEFCA is expected before 2019 which is also the year that Meaningful Use Stage 3 goes into effect.

Over nearly two decades of intense computing growth, the one thing that has remained constant in healthcare interoperability is a strategy built on keeping patient consent out of the solution space. The 2018 TEFCA draft is still designed around HIPAA and ongoing legislative activity in Washington seeks further erosion of patient consent through the elimination of the 42CFR Part 2 protections that currently apply to sensitive health data like behavioral health.

The futility of patient matching without consent parallels the futility of large-scale interoperability without consent. The lack of progress in patient matching was most recently chronicled by Pew through a survey and a Pew-funded RAND report. The Pew survey was extensive and the references cite the significant prior efforts including a 100-expert review by ONC in 2014 and the $1 million CHIME challenge in 2017 that was suspended – clear evidence of futility.

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Hoarding Patient Data is a Lousy Business Strategy: 7 Reasons Why

Leslie Kelly Hall
Vince Kuraitis

By VINCE KURAITIS & LESLIE KELLY HALL

Among many healthcare providers, it’s been long-standing conventional wisdom (CW) that hoarding patient data is an effective business strategy to lock-in patients — “He who holds the data, wins”. However…we’ve never seen any evidence that this actually works…have you?

We’re here to challenge CW. In this article we’ll explore the rationale of “hoarding as business strategy”, review evidence suggesting it’s still prevalent, and suggest 7 reasons why we believe it’s a lousy business strategy:

  1. Data Hoarding Doesn’t Work — It Doesn’t Lock-In Patients or Build Affinity
  2. Convenience is King in Patient Selection of Providers
  3. Loyalty is Declining, Shopping is Increasing
  4. Providers Have a Decreasingly Small “Share” of Patient Data
  5. Providers Don’t Want to Become a Lightning Rod in the “Techlash” Backlash
  6. Hoarding Works Against Public Policy and the Law
  7. Providers, Don’t Fly Blind with Value-Based Care

Background

In the video below, Dr. Harlan Krumholz of Yale University School of Medicine capsulizes the rationale of hoarding as business strategy.

We encourage you to take a minute to listen to Dr. Krumholz, but if you’re in a hurry we’ve abstracted the most relevant portions of his comments:

“The leader of a very major healthcare system said this to me confidentially on the phone… ‘why would we want to make it easy for people to get their health data…we want to keep the patients with us so why wouldn’t we want to make it just a little more difficult for them to leave.’ …I couldn’t believe it a physician health care provider professional explaining to me the philosophy of that health system.”

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Ensuring that the 21st Century Cures Act Health IT Provisions Promotes Interoperability and Data Exchange

Dan Gottlieb MPA
Josh C. Mandel MD
Kenneth D. Mandl MD

By KENNETH D. MANDL, MD; DAN GOTTLIEB MPA;
JOSH C. MANDEL, MD

The opportunity has never been greater to, at long last, develop a flourishing health information economy based on apps which have full access to health system data–for both patients and populations–and liquid data that travels to where it is needed for care, management and population and public health. A provision in the 21st Century Cures Act could transform how patients and providers use health information technology. The 2016 law requires that certified health information technology products have an application programming interface (API) that allows health information to be accessed, exchanged, and used “without special effort” and that provides “access to all data elements of a patient’s electronic health record to the extent permissible under applicable privacy laws.”

After nearly two years of regulatory work, an important rule on this issue is now pending at the Office of Management and Budget (OMB), typically a late stop before a proposed rule is issued for public comment. It is our hope that this rule will contain provisions to create capabilities for patients to obtain complete copies of their EHR data and for providers and patients to easily integrate apps (web, iOS and Android) with EHRs and other clinical systems.

Modern software systems use APIs to interact with each other and exchange data. APIs are fundamental to software made familiar to all consumers by Google, Apple, Microsoft, Facebook, and Amazon. APIs could also offer turnkey access to population health data in a standard format, and interoperable approaches to exchange and aggregate data across sites of care.

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