“The Health Data Goldilocks Dilemma: Sharing? Privacy? Both?” series will cover a whole host of topics that discuss, clarify, and challenge the notion of sharing data and if it should be kept private or made public. On the one hand, sharing health information is essential for clinical care, powering medical discovery, and enabling health system transformation. On the other hand, the public is expressing greater concerns over the privacy of personal health data. This ‘Goldilocks Dilemma’ has pushed US policymakers towards two seemingly conflicting goals: 1) broader data interoperability and data sharing, and 2) enhanced data privacy and data protection.
But this issue is even more nuanced and is influenced by many moving parts including: Federal & State privacy legislation, health technology legislation, policy & interoperability rules, data usage from AI & machine learning tools, data from clinical research, ethical concerns, compensating individuals for their data, health data business models, & many more.
Fear not, Deven & Vince are here to walk readers through this dilemma and will be providing pieces to help explain what is going on. Most of their discussion & pieces will cover 2 specific affected areas: 1) How are policymakers addressing health data privacy risks, and 2) The impact on business models within the Health Data Goldilocks Dilemma.
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 dashboard is the potent symbol of our age. It offers the elegant visualization of data, and is intended to capture and represent the performance of a system, revealing at a glance current status, and pointing out potential emerging concerns. Dashboards are a prominent feature of most every “big data” project I can think of, offered by every vendor, and constructed to provide a powerful sense of control to the viewer. It seemed fitting that Novartis CEO Dr. Vas Narasimhan, a former McKinsey consultant, would build (then tweet enthusiastically about) “our new ‘control tower’” – essentially a multi-screen super dashboard – “to track, analyse and predict the status of all our clinical studies. 500+ active trials, 70+ countries, 80 000+ patients – transformative for how we develop medicines.” Dashboards are the physical manifestation of the ideology of big data, the idea that if you can measure it you can manage it.
I am increasingly concerned, however, that the ideology of big data has taken on a life of it’s own, assuming a sense of both inevitability and self-justification. From measurement in service of people, we increasingly seem to be measuring in service of data, setting up systems and organizations where constant measurement often appears to be an end in itself.
My worries, it turns out, are hardly original. I’ve been delighted to discover over the past year what feels like an underground movement of dissidents who question the direction we seem to be heading, and who’ve thoughtfully discussed many of the issues that I stumbled upon. (Special hat-tip to “The Accad & Koka Report” podcast, an independent and original voice in the healthcare podcast universe, for introducing me to several of these thinkers, including Jerry Muller and Gary Klein.)
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 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 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.
On one hand, regulators are reluctant to limit private corporate action lest we reduce innovation and patient choice and promote moral hazards. On the other hand, a privatized marketplace for services requires transparency of costs and quality and a minimum of economic externalities that privatize profit and socialize costs.
For over two decades, the HIPAA law and regulations have dominated the way personal health data is used and abused to manipulate physician practice and increase costs. During these decades, digital technology has brought marvels of innovation and competition to markets as diverse as travel and publishing while healthcare technology is burning out physicians and driving patients to bankruptcy.
Abbott Ventures chief Evan Norton may have spent part of his youth on a farm, but there’s no manure in his manner when speaking of the medical device and diagnostics market landscape. The key, he says, is to avoid being blindsided by the transformational power of digital data.
“We’ve been competing against Medtronic and J&J, so that has the risk of us being disintermediated by other players that come into the market,” Norton told attendees at MedCity Invest, a meeting focused on health care entrepreneurs. “Physicians are coming to us and asking for access to data for decisions, and they don’t care who the manufacturer [of the device] is. Are we enabling data creation?”
Abbott, said Norton, wrestles with whether they are simply data creators or want to get paid for providing algorithmic guidance on how the data is used. (Full disclosure: I own Abbott shares.) Other panelists agreed making sense of the digital data deluge remains the central business challenge.
What’s received little attention from physicians or the public is the company’s quiet metamorphosis into a powerhouse focused on the actual practice of medicine.
If “data is the new oil,” as the internet meme has it, Google and its Big Tech brethren could become the new OPEC. Search is only the start for Google and its parent company, Alphabet. Their involvement in health care can continue through a doctor’s diagnosis and even into monitoring a patient’s chronic condition for, essentially, forever. (From here on, I’ll use the term Google to include the confusing intertwining of Google and Alphabet units.)