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Legal Insights and Perspectives for the Healthcare Industry

Healthcare is a highly regulated space, and regulators are continuing to issue new policies and regulations to address the critical needs for goods and services to combat the coronavirus (COVID-19), while also protecting the public health. Companies beyond just healthcare and life sciences should be aware of the relevant regulatory and legal requirements to avoid enforcement and liability requests.

In this LawFlash, you will find an overview of key areas of law and regulation, including FDA regulation, product liability and the PREP Act, clinical testing oversight, digital health and telehealth, and healthcare regulation and reimbursement, that impact companies marketing products or services to support COVID-19 efforts.

Read the full LawFlash >>

Healthcare partners Al Shay and Howard Young and associate Jake Harper recently contributed to the Health Care Compliance Legal Issues Manual, a publication by the American Health Lawyers Association (AHLA).

The latest edition of AHLA’s Health Care Compliance Legal Issues Manual gives readers an up-to-date look at issues critical to healthcare compliance, including tips for conducting internal investigations; audit basics; overviews of the False Claims Act, Stark Law, and Anti-Kickback Statute; healthcare privacy; and more.

The Office of Management and Budget’s (OMB’s) policy statement emphasizes the role of the Congressional Review Act in the rulemaking process and incorporates rulemaking actions that were not consistently subject to prepublication review under standing executive orders. Questions remain regarding the prospects for regulatory gridlock and burdensome delays.

A recent OMB memorandum instructs departments and agencies of the executive branch to submit “guidance documents, general statements of policy, and interpretive rules” to the OMB’s Office of Information and Regulatory Affairs (OIRA) for prepublication review. The April 11 memorandum, which also expands OIRA review to agency rules historically submitted through the centralized process designated in Executive Order 12866, is effective May 11, 2019. Regulatory watchers caution that the OMB’s action could increase the volume of rules that require OIRA review and potentially result in regulatory gridlock and rulemaking delays.