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Legislation that would amend California’s Confidentiality of Medical Information Act (“CMIA”) is working its way through California’s Senate and passed in the Senate Health Committee earlier this week.  The proposed bill passed in the state’s Assembly back in April.  Introduced by Democratic California Assemblymember Edwin Chau, who sits on the Privacy and Consumer Protection Committee, the proposed legislation (AB 1436) expands the definition of “provider of health care.”  Under the CMIA, providers of health care are subject to various obligations, including provisions that restrict the disclosure of medical information without a prior valid authorization, subject to certain exceptions. …
Continue Reading Proposed Bill Would Expand the Scope of the CMIA

On September 2, 2020, the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) announced a new “Health Apps” feature on the HHS.gov website.  The new website, which replaces the OCR’s Health App Developer Portal, highlights existing guidance for mobile health (“mHealth”) apps regarding the Health Insurance Portability and Accountability Act…

The COVID-19 crisis is demonstrating the potential of digital health technology to manage some of our greatest public health challenges.  The White House Office of Science and Technology Policy has issued a call to action for technology companies to help the science community answer high-priority scientific questions related to COVID-19.  The Centers for Disease Control…

Product liability considerations are not likely the first concerns that spring to mind for the many companies working to develop digital health countermeasures and other products related to COVID-19.  Yet even while putting together solutions on an accelerated timeline, there are some straightforward actions that companies can take that may reduce litigation risk down the…

On March 9, 2020, the Department of Health and Human Services (HHS) issued two final rules aimed at improving patient access to electronic health information (EHI), as well as the standardization of modes of exchange for EHI.  The rules, which were issued by the Office of the National Coordinator for Health Information Technology (ONC) and…

On February 27, 2020 NHSX, the technology and digital unit of the NHS, published its draft Digital Health Technology Standard (the “Standard”) for consultation to stakeholders in the digital health space (the “Consultation”). The Consultation is open until 22 April, 2020 (and is available here).

The Standard, which is based on existing industry and health standards, is intended to streamline how digital health technologies are reviewed and commissioned by the NHS and social care.

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Continue Reading NHSX Consults on Draft Digital Health Technology Standard

Germany recently enacted a law that enables state health insurance schemes to reimburse costs related to the use of digital health applications (“health apps”), but the law requires the Federal Ministry of Health to first develop the reimbursement process for such apps.  Accordingly, on January 15, 2020, the German government published a draft regulation setting…