A few weeks ago, WTF Health took the show on the road to Australia’s digital health conference, HIC 2019. We captured more than 30 interviews (!) from the conference, which is run by the Health Informatics Society of Australia (hence the HISA Studio branding) and I had the opportunity to chat with most of the Australian Digital Health Agency’s leadership, many administrators from the country’s largest health systems, and a number of health informaticians, clinicians, and patients. I’ll be spotlighting a few of my favorites here in a four-part series to give you a flavor of what’s happening in health innovation ‘Down Under.’ For much more, check out all the videos on the playlist here.
I’d like to kick off the series with my interview on all things interoperability with arguably the most famous Australian in health tech, Grahame Grieve.
Grahame Grieve, “the Father of FHIR” architected healthcare’s best shot at EMR data interoperability when he founded HL7’s Fast Healthcare Interoperability Resources (FHIR), but have you heard what prompted Grahame to pursue creating a common standard for electronic health data exchange in the first place? Grahame shares the surprisingly personal and emotional story and weighs in how he thinks FHIR adoption is going so far. If your business has anything to do with health IT, EMR, or healthcare’s play in big data, be sure to tune in to find out what’s next for FHIR, whether or not Big Tech’s new role in healthcare can help speed up adoption, and if Grahame thinks we’ll ever finally solve healthcare’s interoperability problem.
Filmed in the HISA Studio at HIC 2019 in Melbourne, Australia, August 2019.
Robust exchange of health information is absolutely critical to improving health care quality and lowering costs. In the last few months, government leaders at the US Department of Health and Human Services (HHS) have advanced ambitious policies to make interoperability a reality. Overall, this is a great thing. However, there are places where DC regulators need help from the frontlines to understand what will really work.
As California’s largest nonprofit health data network, Manifest MedEx has submitted comments and met with policymakers several times over the last few months to discuss these policies. We’ve weighed in with Administrator Seema Verma and National Coordinator Dr. Don Rucker. We’ve shared the progress and concerns of our network of over 400 California health organizations including hospitals, health plans, nurses, physicians and public health teams.
With the comment periods now closed, here’s a high-level look at what lies ahead:
CMS is leading on interoperability (good). Big new proposals from the Centers for Medicare and Medicaid Services (CMS) will set tough parameters for sharing health information. With a good prognosis to roll out in final form around HIMSS 2020, we’re excited to see requirements that health plans give patients access to their claims records via a standard set of APIs, so patients can connect their data to apps of their choosing. In addition, hospitals will be required to send admit, discharge, transfer (ADT) notifications on patients to community providers, a massive move to make transitions from hospital to home safe and seamless for patients across the country. Studies show that readmissions to the hospital are reduced as much as 20% when patients are seen by a doctor within the first week after a hospitalization. Often the blocker is not knowing a patient was discharged. CMS is putting some serious muscle behind getting information moving and is using their leverage as a payer to create new economic reasons to share. We love it.
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 are open to interpretation, we
invite readers to respond
with their own ideas, corrections and opinions.
Interventions to Address Market Failures
Many of the rules proposed
by CMS and ONC are evidence-based interventions aimed at critical problems that
market forces have failed to address. One example of market failure is the long-standing inability for health care
providers and insurance companies to find a way to exchange patient data. Each
has critical data the other needs and would benefit from sharing. And, as CMS
noted, health plans are in a “unique position to provide enrollees a complete
picture of their clams and encounter data.” Despite that, technical and
financial issues, as well as a general air of distrust from decades of haggling
over reimbursement, have prevented robust data exchange. Remarkably, this happens
in integrated delivery systems which, in theory, provide tight alignment between
payers and providers in a unified organization.
With so much attention
focused on requirements for health IT companies like EHR vendors and providers,
it is easy to miss the huge impact that the new rules is likely to have for
payers. But make no mistake, if implemented as proposed, these rules will have
a profound impact on the patient’s ability to gather and direct the use of
their personal health information (PHI). They will also lead to reduced
fragmentation and more complete data sets for payers and providers alike.
Overview of Proposed CMS Rules on Information
Sharing and Interoperability
The proposed CMS rules
affect payers, providers, and patients stating that they:
Require payers to make
patient health information available electronically through a standardized,
open application programming interface (API)
Promote data exchange
between payers and participation in health information exchange networks
Require payers to provide
additional resources on EHR, privacy, and security
Require providers to comply
with new electronic notification requirements
Require states to better
coordinate care for Medicare-Medicaid dually eligible beneficiaries by
submitting buy-in data to CMS daily
Publicly disclose when
providers inappropriately restrict the flow of information to other health care providers and payers
Today, THCB is spotlighting Lygeia Ricciardi. As the former Director of Consumer e-Health at the ONC, Lygeia tells us about patient access to health data and the ONC and CMS’s new rules on interoperability. But now, she’s the CTO of Carium Health, going from a “consumer activist consultant-type” to actually working with a startup. Carium provides a platform for consumer empowerment and engagement, helping to guide individuals through their health care and wellness journeys.
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 five of this series, we look at how competition unlocks innovation, and how the proposed rules may disrupt the balance between innovation, intellectual property (IP), and supporting business models.
The recent publication of proposed rules by ONC and CMS set off a flurry of activity. In anticipation of their implementation, the health care industry is wrestling with many questions around business models. What practices inhibit competition and innovation? How do we balance the need for competition while protecting legitimate intellectual property rights? How can vendors ensure profit growth when pricing is heavily regulated? In this article, we will examine how competition unlocks innovation and the possible disruptions the proposed rules may bring for innovation, intellectual property (IP) and supporting business models.
In most markets, innovation is driven forward by competition. Businesses compete on equal footing, and their investment in R&D drives innovation forward. Innovation in health care has been dramatically outpaced by other markets, leading to an urgent need for both disruptive and evolutionary innovation.
What is inhibiting health care innovation? The rules identify a combination of tactics employed in health care that restrict the free flow of clinical data, such as:
These tactics slow innovation by contributing to an
environment where stakeholders resist pushing the boundaries — often because
they are contractually obligated not
to. The legislation and proposed rules are designed to address the ongoing
failure of the market to resolve these conflicts.
As the rules are finalized, we will continue to monitor whether
the ONC defines these practices as innovation stifling and how they will
implement regulations — both carrot and stick — to move the industry forward.
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.
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.
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.
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.”
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.
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.
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.
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.
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.
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.
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.