21st Century Cures Act

See the following -

A New Pothole on the Health Interoperability Superhighway

Adrian Gropper | The Health Care Blog | August 15, 2017

On July 24, the new administration kicked off their version of interoperability work with a public meeting of the incumbent trust brokers. They invited the usual suspects Carequality, CARIN Alliance, CommonWell, Digital Bridge, DirectTrust, eHealth Exchange, NATE, and SHIEC with the goal of driving for an understanding of how these groups will work with each other to solve information blocking and longitudinal health records as mandated by the 21st Century Cures Act...

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Are jackalopes and information blocking similar?

Looking to dupe urbanite travelers, bartenders and bar owners in rural Western taverns sometimes fasten antelope horns to the head of a large jackrabbit. They then mount the whole thing, hang it over the bar and tell visitors looking for a craft brewed IPA to watch for vicious jackalopes when they’re out and about. So, are we having a jackalope moment in health IT? Do we believe in something we can’t see? The suggestion has been made that some vendors are actively engaged in “information blocking”—a basic refusal to exchange patient data with other systems. Either that or they’re charging boatloads of money to do so, which is framed as a form of information blocking in a way, but not exactly.

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GAO Makes Appointments to Health Information Technology Advisory Committee

Press Release | Government Accountability Office (GAO) | August 3, 2017

Gene L. Dodaro, Comptroller General of the United States and head of the U.S. Government Accountability Office (GAO), today announced 15 appointments to the new Health Information Technology (HIT) Advisory Committee. It is extremely valuable to have a range of perspectives and expertise in helping the government address challenges related to health information technology, “It is extremely valuable to have a range of perspectives and expertise in helping the government address challenges related to health information technology,” Dodaro said...

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Halamka's Report on the May 2015 HIT Standards Committee Meeting

The May 2015 HIT Standards Committee focused on an in depth review of the ONC Notice of Proposed Rulemaking, with the goal of providing guidance to ONC by June as to which standards should be included in final rule, which should not be included, and which should be identified as directionally appropriate for inclusion in future regulation.The meeting began with the ONC announcement that the HITSC workgroups would be disbanded in June and replaced by focused task forces.

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Halamka: A Time of Great Turmoil in Healthcare IT Policy Making

We are in a time of great turmoil in healthcare IT policy making.   We have the CMS and ONC Notices of Proposed Rulemaking for Meaningful Use Stage 3, both of which need to be radically pared down. We have the Burgess Bill which attempts to fix interoperability with the blunt instrument of legislation. Most importantly we have the 21st Century Cures Act, which few want to publicly criticize. I’m happy to serve as the lightening rod for this discussion, pointing out the assumptions that are unlikely to be helpful and most likely to be hurtful. Read More »

Health Care Data as a Public Utility: How Do We Get There?

Mohit Kaushal and Margaret Darling | Brookings | May 18, 2016

Despite the technological integration seen in banking and other industries, health care data has remained scattered and inaccessible. EHRs remain fragmented among 861 distinct ambulatory vendors and 277 inpatient vendors as of 2013.Similarly, insurance claims are stored in the databases of insurers, and information about public health is often kept in databases belonging to various governmental agencies. These silos wouldn’t necessarily be a problem, except for the lack of interoperability that has long plagued the health care industry. For this reason, many are reconsidering if health care data is a public good, provided to all members of the public without profit...

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Health IT Security, FHIR Focus of ONC Secure API Server Challenge

Elizabeth Snell | HealthIT Security | October 10, 2017

ONC is challenging healthcare stakeholders to build secure Fast Healthcare Interoperability Resources (FHIR) servers to improve health IT security and ensure that secure FHIR options are available in the future. The Secure API Server Showdown Challenge will ideally “identify unknown security vulnerabilities in the way open source FHIR servers are implemented,” ONC Office of Standards and Technology Director Steven Posnack, MS, MHS, wrote in a blog post...

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HHS Called on to Eliminate Health Information Blocking

Kate Monica | EHR Intelligence | August 31, 2017

A coalition of healthcare stakeholders convened by Health IT Now called HHS and its departments to eliminate information blocking so that providers can effectively aggregate patient EHRs and advance interoperability. The letter from organizations including the American Academy of Family Physicians (AAFP), AMIA, DirectTrust, and athenahealth requested HHS issue a proposed rule that takes existing laws, standardization, patient health data access, and other complicating factors into consideration...

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Obama and Biden Blast EHR Vendors for Data Blocking

As they are winding their terms in office, President Barack Obama and Vice President Joe Biden dropped a stink bomb on the health IT industry. Speaking at different events on Friday, January 9th, the President and Vice President both criticized proprietary electronic health record (EHR) vendors as the primary obstacle to the success of their administration’s health care strategy. This is the highest level acknowledgement so far of the serious impact that “lock-in” EHR software vendors are having on America’s medical infrastructure and the ability of physicians to provide medical care.

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ONC Head Dr. Donald Rucker Addresses open API's, Interoperability and Usability During WEDI Keynote

Press Release | Workgroup for Electronic Data Interchange (WEDI) | August 23, 2017

Earlier this month, the Workgroup for Electronic Data Interchange (WEDI), the nation’s leading nonprofit authority on the use of health IT to create efficiencies in healthcare information exchange and a trusted advisor to the U.S. Department of Health and Human Services (HHS), held its 2017 Summer Forum which featured keynote addresses by Donald W. Rucker, MD, head of the Office of the National Coordinator for Health Information Technology (ONC/HHS) and Madhu Annadata, director, Division of National Standards, Centers for Medicare & Medicaid Services (CMS)...

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ONC Interoperability Meeting Raises More Questions Than Answers

Adrian Gropper | The Health Care Blog | July 25, 2017

ONC’s first public event under the new administration was very well organized and run. Eight leading health information exchange incumbents were able to describe their current approaches and plans, the patient advocate position was clearly stated, and a nice synthesis of the issues raised by the trusted framework approach to interoperability was prepared by a consulting organization. Much to ONC’s credit, they went out of their way to provide access and public comment to an extent that is unprecedented in my experience. Slides and recordings will be posted soon and a 30-day comment period runs through August 24. Kudos to ONC...

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ONC Selects Noam Arzt to to serve on the ONC Trusted Exchange Framework Task Force

Press Release | HLN Consulting | February 19, 2018

The Office of the National Coordinator for Health Information Technology (ONC) has selected Dr. Noam H. Arzt, President of HLN Consulting (HLN), as a member of the Trusted Exchange Framework Task Force. This group of healthcare and health information technology specialists will advise ONC on various aspects of the Draft Trusted Exchange Framework. This framework outlines a common set of principles for trusted exchange of health information records and minimum terms and conditions for trusted exchange as directed by Congress in the 21st Century Cures Act.

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ONC's Trusted Exchange: A Public Health Perspective

In January 2018 the Office of the National Coordinator for Health Information Technology (ONC) issued a draft Trusted Exchange Framework and Common Agreement (TEFCA), and related supporting documents, in response to a requirement imposed by Congress in the 21st Century Cures Act. The Act says that the TEF may include a common method for authenticating users, a common set of rules, enabling policies, and a process for managing non-compliance. Nowhere does the Act instruct ONC to determine an actual technical architecture in this process, though such a step is not precluded either. The primary document is in two parts: Part 1 is a set of principles that set the foundation for Part 2 which is a set if minimum terms and conditions for trusted exchange.

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Questions About The FDA’s New Framework For Digital Health

Nathan G. Cortez, Nicolas Terry, and I. Glenn Cohen | Health Affairs Blog | August 16, 2017

In June 2017, the new Food and Drug Administration (FDA) commissioner Scott Gottlieb pre-announced his agency’s Digital Health Innovation Action Plan that indicates notable shifts in the agency’s approach to digital health technologies. This plan is an important step in FDA regulation of this area, a process that began in 2011 with a draft guidance, followed by significant congressional actions. The new changes should not be surprising, given critiques published by Gottlieb prior to re-joining the FDA...

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Report on the ONC 2017 Technical Interoperability Forum

Last week I attended with my colleague Mike Berry the ONC 2017 Technical Interoperability Forum. This meeting was convened under the 21st Century Cures Act passed by Congress in late 2016. Several hundred participants attended a series of panel presentations and discussions. The forum took place over one-and-a-half-days. The forum covered a variety of topics related to interoperability, including discussion of the business case for interoperability, semantics, national networks, and application programming interfaces (APIs). In many ways the speakers were “the usual suspects” involved in national networks, standards development, and HIE planning and implementation.

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