Interoperability and patient access to data has been pushed to the forefront as a primary concern for the health industry. This is largely due to proposed rules published this spring by the Office of the National Coordinator for Health Information Technology (ONC) and the Center for Medicare and Medicaid Services (CMS) that seek to advance interoperability and support the access, exchange, and use of electronic health information. In August 2019, the ONC held its third annual National Coordinator for Health IT Interoperability Forum in Washington DC. The event brings together the ...
On January 5, 2018, consistent with the 21st Century Cures Act’s focus on creating interoperability and correspondingly a Trusted Exchange, the Office of the National Coordinator for Health Information Technology (“ONC”) released its “Draft Trusted Exchange Framework” (“Draft Framework”). The Draft Framework is intended to streamline the exchange of Electronic Health Information (“EHI”) so that both health care providers and patients have better access to health information, thus improving communication and quality health care. EHI includes ...
On May 17, 2016, FDA issued Draft Guidance for Industry on Use of Electronic Health Record Data in Clinical Investigations ("Draft Guidance"). This Draft Guidance builds on prior FDA guidance on Computerized Systems Used in Clinical Investigations and Electronic Source Data in Clinical Investigations, and provides information on FDA's expectations for the use of Electronic Health Record ("EHR") data to clinical investigators, research institutions and sponsors of clinical research on drugs, biologics, medical devices and combination products conducted under an ...
FDA published the long awaited draft guidance on wellness products last Friday. The guidance is a positive step forward for industry in that it proposes that certain general wellness products will not be subject to FDA regulation.
The draft guidance clarifies that FDA does not intend to enforce its regulations against products that are "low risk" and are intended to:
- Maintain or encourage health without reference to a disease or condition (e.g. weight, fitness, stress) or
- Help users live well with or reduce risks of chronic conditions, where it is well accepted that a healthy ...
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