ONC seeks comment on Trusted Exchange Framework aimed at facilitating greater interoperability of health information

On January 5, 2018, the Department of Health and Human Services’ Office of the National Coordinator for Health Information Technology (ONC) released a draft Trusted Exchange Framework and Common Agreement (TEFCA), outlining a common set of principles for trusted exchange of health data and interoperability between health information networks (HINs) and proposing a Common Agreement aimed at operationalizing the principles for data exchange in an effort to drive interoperability. ONC released the draft framework in compliance with provisions of the 21st Century Cures Act, which was enacted in December 2016.

The draft framework is part of an effort “to scale interoperability nationwide by providing a single ‘on-ramp’ to allow all types of healthcare stakeholders to join any health information network they choose and be able to participate in nationwide exchange, regardless of what health IT developer they use, health information exchange or network they contract with, or where the patients’ records are located.”

Comments on the draft framework are due to ONC by February 20, 2018. ONC will post comments on its website. ONC will consider comments on the draft framework as it develops a final TEFCA product, which will be posted on the ONC website and published in the Federal Register.

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President Obama signs 21st Century Cures Act, including provisions with significant implications for health plans and health care providers

President Obama on Tuesday, December 13, 2016, signed into law H.R. 34, the 21st Century Cures Act. Although the law focuses largely on the Food and Drug Administration, the National Institutes of Health, and issues of primary interest to life sciences companies, the new law includes provisions with significant implications for health care providers and health plans, especially those offering Medicare Advantage products. The provisions in some cases will affect compliance plans, Medicare payments, and strategic opportunities for organizations, making it imperative that provider and plan leaders take time to review how the 21st Century Cures Act might affect their organization.

Highlights of key provisions affecting health plans and health care providers are provided below.

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21st Century Cures Act (H.R. 6)

The 21st Century Cures Act (“the Act”) is intended to address a significant number of current challenges within the industry including reduction of barriers to research collaboration, incorporation of the patient perspective into the drug development and regulatory review process, earlier identification of diseases through personalized medicine, modernization of clinical trials, and the elimination of regulatory uncertainty for the development of new medical applications. It also includes provisions to incentivize the development of drugs for rare diseases, invest in science and the next generation of investigators, and support the biomedical ecosystem to accelerate discovery of new cures.

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