In response to President Trump’s call to action on opioids, acting Department of Health and Human Services (HHS) Secretary Eric D. Hargan declared the opioid crisis a national public health emergency on October 26, 2017. The next day, HHS-Office for Civil Rights (OCR) released new guidance on when and how health care providers can share a patient’s health information with the patient’s family and close friends during certain crisis situations, such as opioid overdoses, without violating the Health Insurance Portability and Accountability Act (HIPAA) privacy regulations.
HIPAA prohibits health care providers from sharing protected health information about patients who have capacity to make their own health care decisions and object to information sharing, unless there is a serious and imminent threat of harm or safety. However, health care professionals may disclose some health information without a patient’s permission under certain circumstances, including:
The FDA recently issued new guidance that allows institutional review boards (IRBs) to waive or alter the FDA’s informed consent requirements for certain minimal risk clinical investigations without objection from the FDA.
The statutory basis for the guidance comes from amendments made by the 21st Century Cures Act from late in 2016 (P.L 144-255). This guidance, which took effect on July 25, 2017, is the first step for the FDA on this issue. The FDA intends to implement subsequent regulations to permit IRB waiver or alterations of informed consent requirements for minimal risk clinical investigations.
In a previous blog post, our team evaluated the draft recommendations prepared by the Health Care Industry Cybersecurity Task Force in its “Report on Improving Cybersecurity in the Health Care Industry.”
We recently examined three of the six major recommendations in the report and their potential impact on the existing health care regulatory environment. These include:
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