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.
Today on Health in 2 Point 00, Jess and I are in New Orleans at the ATA Annual Conference. In this episode, Jess asks me about my takeaways from the conference, Cityblock’s $65 million raise, and Microsoft HealthVault shutting down. In terms of virtual care, it seems that there’s been low adoption of telehealth visits—but things are on the cusp, with lots of companies doing interesting things and with CMS expanding Medicare Advantage coverage of telehealth services. —Matthew Holt
The Robert Wood Johnson Foundation (RWJF) has partnered with Catalyst @ Health 2.0 to launch two innovation challenges on Social Determinants of Health (SDoH) and Home & Community Based Care. As a national leader in building a culture of health, RWJF is inspiring and identifying novel digital solutions to tackle health through an unconventional lens.
Health starts with where we live. As noted in Healthy People 2020 social determinants
of health are, “conditions in the environments in which people are born, live,
learn, work, play, worship, and age… [that] affect a wide range of health
functioning, and quality-of-life outcomes and risks.” For example, children who
live in an unsafe area cannot play outside making it more difficult for them to
have adequate exercise. Differences in SDoH heavily influences communities’
well-being and results in very different opportunities for people to be
Despite our knowledge on SDoH, the current healthcare system utilizes care models that often fail to take into account the social and economic landscape of communities– neglecting factors such as housing, education, food security, income, community resources, transportation and discrimination. Little progress has been made on incorporating SDoH into established health care frameworks. Healthcare providers and patients alike either have limited understanding of SDoH or have limited opportunities to utilize SDoH knowledge. RWJF established the “Social Determinants of Health Innovation Challenge” to find novel digital solutions that can help providers and/or patients connect to health services related to SDoH.
Home and community-based care is also important to enable Americans to live the healthiest lives possible. In-patient and long-term institutional care can be uncomfortable, costly, and inefficient. Digital health solutions in the home and community offer opportunities for care that better suit the patient and their loved ones. For example, innovations such as remote patient monitoring (RPM) have created new care models that allow the providers, caregivers, and patients to manage care where a person is most comfortable. RPM serves as a reminder that technologies in the home and community offer alternatives methods to engage the patient, increase access to care, and receive ongoing care. Therefore, RWJF is launching the “Home & Community-Based Care Challenge,” to encourage developers to create solutions that support the advancement of at-home or community-based health care.
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.”
Today, THCB is spotlighting Lightbeam Health Solutions. Lightbeam is an end-to-end population health management solution, which means they build everything from the ground up (i.e. no acquisitions or 3rd party interfaces are used). “Interface to innovation” as Jorge Miranda, CRO of Lightbeam, states, allows Lightbeam to build a health system’s value-based contracts relatively quickly. Their main focus is to generate data insights for ACOs and other provider systems, to engage care teams in the coordination of patient care. This is Lightbeam’s 6th year in the health care field, and with 100 customers and over 20 million patients in their enterprise data warehouse (EDW), they have no signs of slowing down.
Lightbeam has 4 main focuses: data ingestion, data insights, the engagement of the team with the data gathered, and the patient outcomes that result from that data. Lightbeam seeks to use their insights to empower care teams by giving the information back to the caregivers, physicians, and patients. According to them, this creates more transparency in the entire process as well as allows the patient and caregivers to play an active role in their health care process.
The ultimate value that clients (health systems or providers) receive from Lightbeam’s system is cutting costs and improving quality. Lightbeam does this by monitoring engagement numbers and patient outcomes based on the data and insights they gathered, ensuring costs savings for clients as well as an effective approach to cutting the high cost of care today. Lightbeam’s ultimate goal is to replace a manual process that is currently being done by multiple people and using multiple resources, to refocus the target on improving care for everyone involved in the health care system.
Zoya Khan is the Editor-in-Chief of THCB as well as an Associate at SMACK.health, a health-tech advisory service for early-stage startups.
Back in the
‘stone ages’ when I (an MIT grad) was an intern, I was called at 4 AM to see
someone else’s gravely ill patient because her IV had infiltrated. I
started a new one and drew some blood work to check on her status. When
the results came back (on paper) I (manually) calculated her anion gap.
This is simple arithmetic but I had been up all night and didn’t do it right.
rounds the attending assured me that there was nothing I could have done anyway
but, of course, in other circumstances it could have made a difference and an
EHR could have easily done this calculation and brought the problematic result
to my attention. My passion for EHRs and FHIR apps to improve them really
traces back to this patient episode I will never forget.
My criticism of the recent Kaiser Health News and Fortune article Death by 1000 Clicks is generally not about what it says but what it doesn’t say and its tone.
The article emphasizes the undeniable fact that EHRs cause
new sources of medical error that can damage patients. It devotes a lot of ink
to documenting some of these in dramatic terms. Yes, with hundreds of vendors
out there, the quality of EHR software is highly variable. Among the major
weaknesses of some EHRs are awkward user interfaces that can lead to errors. In
fact, one of the highlights of my health informatics course is a demonstration
of this by a physician whose patient died at least in part as a result of a
poor EHR presentation of lab test results.
However, the article fails to pay equal attention to the
ways EHRs can, if properly used, help prevent errors. It briefly mentions that
around a 60% majority of physicians using EHRs feel that they improve quality. The
reasons quality is improved deserved more attention. The article also fails to
discuss some of the new, exciting technologies to improve EHR usability through
innovative third party apps and he real progress being made in data sharing
including patient access to their digital records.
You might not know it yet, but there’s a revolution coming
While digitization has driven innovation across the healthcare sector, the advent of 5G is set to spark a fourth industrial revolution.
3G and 4G networks enabled large-scale change and rapid
modernization. However, 5G delivers what these networks could not: blazing
speeds and ultra-low latencies that permit enormous data transfers between
devices in near-real time. That means that technologies like artificial
intelligence, machine learning and augmented reality will be capable of
transforming the industry as we know it.
Whether it’s strengthening telemedicine connections, implementing new teaching methods at medical school, or connecting large hospitals and clinics, see how 5G-powered technologies will open the door for innovation in healthcare.
Three government experts on a health tech conference panel discuss
the urgency of releasing actionable data; all are women. A more senior
official, another woman, gives a TED-style talk making the same case. And a
four-person, private-sector panel debates privacy and ethics; three of the four
Health Datapalooza, a conference begun with government
sponsorship a decade ago, proclaims its goal as “data liberación” – freeing
health data from deep within federal agencies and giving it to patients and
entrepreneurs. But in 2019, women’s “liberación” seems to have become an
Interestingly, while women’s status in tech was the focus of
a plenary panel on diversity and inclusion, the panelists seemed oblivious to
the robust participation of women in their own meeting.
To put some data behind my subjective impressions, I went
back and examined the list of speakers, who came from a wide range of organizations
and included individual patient activists. I counted 89 men and 99 women. Liberación,
This is interesting for a bunch of reasons. First it’s a good example of how technology is now being applied to help with the almost absurd complexity of modern medicine–complexity that technology has both added to and may yet cure. Secondly, Surveyor Health has been building its technology for several years and (FD) I’ve been advising them off and on since 2009 and know the principals well. Thirdly, and this is mostly for grins, it represents some of the absurd language used to describe our crazy health care system.
What does the tech do? Surveyor Health’s technology is very
complex optimization technology that examines the incredible number of symptoms
and interactions undergone by patients taking multiple medications. As you know
most chronically ill patients are on upwards of half a dozen medications and some
are on many more. The more medications, the more the potential for serious and
sometimes fatal drug-drug interactions, side effects and more. You only have to
think of the litany of celebrity drug deaths (Michael Jackson, Prince, Anna Nicole
Smith, Health Ledger, Tom Petty, to name a few) to understand the seriousness
of the issue. Erick von Schweber, a real theoretical physicist and CEO of
Surveyor Health tells me that when you get above 11 drugs the calculations
involved are more complex than what Google has to do to index the web. (And yes,
he now is allowing me to call it AI!)
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.