21st Century Cures Act

See the following -

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 This plan is an important step in FDA regulation of this area, a process that began in 2011 with a draft guidance, followed by significant congressional actions.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 ONC’s Working Session on Patient Identity and Matching

On Monday, August 31, I attended the final Working Session on Patient Identity and Matching. This virtual event was hosted by the Office of the National Coordinator for Health IT (ONC). This Working Session was a followup to an earlier session back in June 2020. The event last week had over 300 attendees and covered a wide range of topics and technologies related to patient identity and matching. These ONC Working Sessions are being driven by requirements that are part of the 21st Century Cures Act as well as a Congressional request from December 2019 to continue to "...evaluate the effectiveness of current [patient identity and matching] methods and recommend actions that increase the likelihood of an accurate match of patients to their health care data." Much of the focus of this study has been on whether a national patient identifier should be implemented in the US.

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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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The Administration's Cancer Moonshot Will Just Start Coming Together as They Leave Office, but Republicans Can Keep It Going.

Sean Captain | Fast Company | January 29, 2016

When President John F. Kennedy made his moonshot speech in September 1962, he thought he had at least two years left in office—over six if he got reelected. Plus, his party controlled Congress, giving him even more power to reach that goal. President Obama announced his moonshot to cure cancer (to be headed by VP Joe Biden) in his final State of the Union address. This week the administration revealed in a memorandum that the program may not be fully fleshed out until the final weeks of Obama's second term—with Republicans likely still holding Congress and perhaps entering the White House...

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The EHR Debacle: Has Organized Medicine Failed Us?

By now, it should be no secret that physicians in the United States, although largely receptive to the idea of electronic health records (EHRs), are widely dissatisfied with the current state of the art, and with the way that EHR adoption is being implemented.[1] Indeed, Congress[2] has shown continuing – but sometimes seemingly perfunctory – interest in the concerns of physicians and other health care providers, and I am at this point pessimistic about seeing any results of its efforts in the near future unless a more fundamental change is made in our approach. As Einstein noted, “We cannot solve our problems with the same thinking that created them.”

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The Evolving Landscape of Health Information Exchange

The original vision for nationwide health information exchange was a “network of networks” model where local HIEs would interact HIE-to-HIE to form a virtual national network. But notice that many of the new initiatives are essentially solving a different problem: they are enabling point-to-point connections across a wider geography and set of clinical sites. This seems more like a large, single national network rather than leverage of more distributed organizations or implementations. Only time will tell if these private sector initiatives will collaborate, converge or compete. And only time will tell of the limitations of ONC’s ability to influence and provide leadership will creates gaps or provide new opportunities for innovation.

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The Fax of Life

Sarah Kliff | Vox | October 30, 2017

When you walk into the Arlington Women’s Center, you see a spacious waiting room with artwork on the wall, maroon chairs, and a friendly receptionist sitting at the front desk. The obstetrics and gynecology practice serves a high-income suburb of Washington, DC. Framed photographs on the wall advertise the center’s physicians who’ve made lists of the city’s best doctors. It’s a modern, upscale doctor office. But when it needs to share patient records, it turns to an outdated technology: the fax machine...

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The HITECH Era – A Patient-Centered Perspective

Robert M. Wachter, Michael Blum, Aaron Neinstein, and Mark Savage | Connecting Health Data | October 10, 2017

We appreciate the recent perspectives published in the New England Journal of Medicine on the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 and the positive impact that it and resulting health IT policies have had on U.S. health care.1,2 The perspectives highlighted the remarkable increase in adoption and use of electronic health records (EHRs) over the past eight years, thanks to the HITECH Act and to ONC’s and CMS’s implementation of it with major advice and help from the multi-stakeholder HIT Policy and Standards committees...

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The Pathway to Patient Data Ownership and Better Health

Katherine A. Mikk, Harry A. Sleeper, and Eric J. Topol | JAMA | September 25, 2017

Digital health data are rapidly expanding to include patient-reported outcomes, patient-generated health data, and social determinants of health. Measurements collected in clinical settings are being supplemented by data collected in daily life, such as data derived from wearable sensors and smartphone apps, and access to other data, such as genomic data, is rapidly increasing. One projection suggests that a billion individuals will have their whole genome sequenced in the next several years. These additional sources of data, whether patient-generated, genomic, or other, are critical for a comprehensive picture of an individual’s health...

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Too little research backs high-risk medical devices

Susan D. Hall | Fierce Health IT | August 12, 2015

The U.S. Food and Drug Administration's Premarket Approval pathway allows high-risk medical devices on the market with only one study to prove their safety and effectiveness, and there are a limited number of studies done post-market, according to research published in Journal of the American Medical Association. Medical device regulation in the U.S. is more rigorous than in other parts of the world, but "the difference is, in many European countries they have much better capacity to follow devices once they are in practice," senior author Joseph S. Ross, M.D., of the Yale University School of Medicine, told Reuters.

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Update on Patient Matching Activities

I have written several times about patient matching in the US, both in a blog entry and a published article. On December 11, 2017 the Office of the National Coordinator for Health Information Technology (ONC) sponsored a half-day “Interoperability in Action” webinar focused on Patient Matching Milestones at ONC (see slides). The webinar focused on four ONC projects from the past year. Here’s a quick run-down on what they covered. Read More »

When Evidence Says No, but Doctors Say Yes

David Epstein and Propublica | The Atlantic | February 22, 2017

Fiirst, listen to the story with the happy ending: At 61, the executive was in excellent health. His blood pressure was a bit high, but everything else looked good, and he exercised regularly. Then he had a scare. He went for a brisk post-lunch walk on a cool winter day, and his chest began to hurt. Back inside his office, he sat down, and the pain disappeared as quickly as it had come...

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Winners And Losers With The 21st Century Cures Bill

Sydney Lupkin and Steven Findlay | NPR | December 2, 2016

A sprawling health bill that passed the Senate Thursday by a 94 to 5 vote and is expected to gain President Obama's signature is a grab bag for industries, academic institutions and patient groups that spent oodles of time and money lobbying to advance their interests. Senate Majority Leader Mitch McConnell calls it "the most important legislation that Congress will pass this year." Who wins and who loses? Here's the rundown of what's at stake in the 21st Century Cures Act...

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2018 Public Health Informatics Conference

Event Details
Type: 
Conference
Date: 
August 19, 2018 (All day) - August 23, 2018 (All day)

It’s been nearly two years since the National Association of County and City Health Officials (NACCHO) released its multi-article supplement, “Public Health Informatics: A Call to Action,” in the Journal of Public Health Management and Practice. Since then, it’s only become clearer that to effectively serve communities in today’s information-driven world, public health – and its cross-sector partners – must advance and strengthen its capability to transform data into action (e.g., services, interventions, and policies). But forging that capability is no easy feat. Challenges such as underdeveloped information technology (IT) infrastructure, lack of training, and insufficient workforce capacity have made public health informatics seem either intimidating or vastly inaccessible to public health professionals. Despite this, there is a role for informatics within every health department. The 2018 PHI Conference exists to help you learn that role through sessions, workshops, and peer-sharing opportunities that:

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