Below is Alston & Bird’s
Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
Week in Review Highlight of the Week:
This week, President Biden signed a bill extending a moratorium on Medicare sequestration through the end of 2021. Read more about the law and other news below.
I. Regulations, Notices & Guidance
On April 15, 2021, the Food and Drug Administration (FDA) issued guidance entitled,
Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency. FDA is issuing this guidance to describe how the agency will request and conduct voluntary remote interactive evaluations at facilities where drugs are manufactured, processed, packed, or held; facilities covered under FDA’s bioresearch monitoring (BIMO) program; an
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BOSTON, April 15, 2021 /PRNewswire/ Chilmark Research s latest report,
Integration Infrastructure: Building 21st Century Health Information Technology, captures a market transitioning to new approaches to development and integration, enabling more effective access to data across organizations and applications. This market for integration technology and services will amount to $2.09 billion by 2026, representing a 14% CAGR. However, non-traditional sectors, including Life Sciences, will grow far faster (3-4 times the rate of traditional buyers) and will amount to the largest single market for this technology by 2026.
Providers and Payers Want Alternatives
While much attention has been focused on how the 21
st Century Cures Act will expand data availability across healthcare, the new rules are just one of the reasons that the industry is looking to leverage data across applications and organizations in new ways. Faster and less costly alternatives to existin
Jae C. Hong
Associated Press
The federal agency that oversees health information technology, the Office of the National Coordinator for Health Information Technology (ONC), on April 5 announced a long-awaited requirement of what electronic health data must be made available to patients and their providers. This represents a significant step toward improving the quality of care when patients see multiple doctors and ensuring that individuals can view their records. These enhancements will advance data-sharing and access, but ONC’s work is not done and further delays in implementing these rules could set this progress back.
As part of the 21
st Century Cures Act, enacted in 2016, Congress used the term “information blocking” to refer to a consistent failure to effectively share data with doctors and health systems that are authorized to view it. The new rules from ONC, which were introduced in May 2020, confront that problem by requiring that information stored within electro