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Legal Insights and Perspectives for the Healthcare Industry
The US Food and Drug Administration (FDA) recently issued new draft guidance on clinical decision support (CDS) software that revamps the agency’s interpretation of the 21st Century Cures Act and proposes new policies of enforcement discretion for some categories of CDS software.

Traditionally a month of beginnings and endings, September is when we transition from the idle warmth of long summer days to the heightened activity of a chilled and busy autumn. For Health Law Scan, September was notable for our analysis of the US Court of Appeals for the Eleventh Circuit’s decision in United States v. Aseracare, which found that mere differences of clinical opinion cannot be fraud under the False Claims Act.

We invite you to join us on Thursday, October 17, for an overview discussion about federal rulemaking, including procedural and de facto changes under the current administration. In this A–Z of Federal Rulemaking webinar, Susan Harthill, Jonathan Snare, and Timothy Lynch will discuss the impact of participating in federal rulemaking, how to get involved, the roles of the Office of Management and Budget and Office of Information and Regulatory Affairs, and more.
Highlighting the US Department of Health and Human Services’ (HHS) efforts to transform the US healthcare system to a value-based model, the Office of the Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) have issued two proposed rules that seek to alter the landscape of healthcare program integrity and fraud and abuse regulation, as part of what HHS calls the “Regulatory Sprint to Coordinated Care Initiative.”
New York’s Stop Hacks and Improve Electronic Data Security Act, or SHIELD Act, which makes significant changes to the state’s data breach notification requirements, impacts healthcare organizations that hold computerized data with private information from New York residents. In this LawFlash, our privacy and cybersecurity team analyzes the law’s expanded definition of “private information” and offers key business takeaways for assessing compliance with the SHIELD Act, which becomes effective October 23, 2019.
In an Up & Atom blog post, Morgan Lewis partner Lewis Csedrik and associate Roland Backhaus detail the ACMUI’s most recent review of reported medical events and discuss the NRC’s Information Notice with recommendations to prevent their reoccurrence.
It’s October 1, and that means this month is the deadline for the US Drug Enforcement Agency (DEA) to issue its final rules on special registration for telemedicine.
Our prior post discussed three potential enhancements to cyber-related liability insurance policies designed to maximize their potential responsiveness to actions initiated by consumers or the state attorney general under the California Consumer Privacy Act (CCPA).
Will typical cyber-related liability insurance policies respond to actions initiated under the CCPA? In their current form, many likely will not. This post suggests enhancements to existing cyberliability policies to maximize their potential responsiveness to CCPA actions.