North America

Podcast: Owner’s Outlook: Health Care Construction in a Period of Labor Shortages / Cost Inflation – Diagnosing Health Care

In this episode of the Diagnosing Health Care Podcast:  Staffing challenges and cost inflation are seriously impacting health care construction as well as other sectors of the U.S. construction economy.

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CMS Reduces COVID-19 Vaccine Mandate Surveys and Rescinds Surveyor Vaccination Requirements

In two recent memoranda, the Centers for Medicare and Medicaid Services (CMS) made changes to previously issued survey guidance related to COVID-19 vaccination issues.

In QSO-22-17-ALL, CMS modified the frequency by which State Agencies and Accreditation Organizations will survey for compliance with the federal staff vaccine mandate applicable to health care providers and suppliers (discussed in a prior post).  Noting that 95% of providers and suppliers surveyed have been found in substantial compliance with the rule, CMS is eliminating the previous requirement that State Agencies and Accreditation Organizations survey for compliance with the vaccine mandate during every survey.  Review of compliance with vaccine mandate is still required, however, during initial surveys, recertification surveys, and in response to specific complaint allegations that allege non-compliance with the staff vaccination requirement.  This means that a State Agency or Accreditation Organization is not required to review compliance with the staff vaccination requirement during, for example, a validation survey or a complaint survey unrelated to compliance with the staff vaccination requirement.  A State Agency or Accreditation Organization may still choose to expand any survey to include review of vaccine mandate compliance; however, the new guidance should result in a reduction in survey frequency of this issue for providers and suppliers.

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The Pendulum Swings Both Ways: State Responses to Protect Reproductive Health Data, Post-Roe

The U.S. Supreme Court is expected to imminently issue its opinion in the case Dobbs v. Jackson Women’s Health Organization (“Dobbs”). If the Court rules in a manner to overturn Roe v. Wade, states will have discretion in determining how to regulate abortion services.[1] Such a ruling would overturn nearly 50 years of precedent, leaving patients, reproductive health providers, health plans, pharmacies, and may other stakeholders to navigate a host of uncharted legal issues. Specifically, stakeholders will likely need to untangle the web of cross-state legal issues that may emerge.

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Unpacking Averages: Violations Found in Medical Device Warning Letters

Most companies want to avoid FDA warning letters.  To help medical device companies identify violations that might lead to a warning letter, this post will dive deeply into which specific types of violations are often found in warning letters that FDA issues.

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Podcast: OSHA’s Permanent COVID-19 Standard and Enforcement Blitz – Diagnosing Health Care

In this episode of the Diagnosing Health Care Podcast:  What challenges are providers likely to face as the Occupational Safety and Health Administration (OSHA) prepares its permanent COVID-19 standard for health care workers?

Attorneys Denise DadikaBob O’Hara, and Tim Murphy review the provisions of OSHA’s temporary COVID-19 standard for health care workers and what’s expected to change under the permanent rules. They also discuss how the agency’s current enforcement push is impacting health care providers.

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The VALID Act: Senate Action Brings FDA Regulation of LDTs Closer to Fruition

Since the passage of the Medical Device Amendments of 1976, FDA has regulated in vitro diagnostic (IVD) tests as medical devices, subject to a full suite of FDA requirements.  During that time, FDA has also asserted that it has the authority to regulate in-house tests developed and performed by CLIA-certified, high-complexity clinical laboratories (generally referred to as laboratory-developed tests or LDTs) but chose as a matter of enforcement discretion not to regulate LDTs.  Over time, the Agency chipped away slowly at LDT enforcement discretion, carving out certain kinds of tests (e.g., direct-to-consumer LDTs) and thus making them subject to regulation, but by and large did not take broad steps to regulate LDTs.

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Recent FDA Enforcement Action Colors Regulatory Landscape for Delta-8 THC Products

Much like the ambiguous landscape involving cannabidiol (CBD) products on the consumer market, an influx of delta-8 THC containing products for consumption has highlighted a recurrent regulatory issue surrounding the legality of hemp derived products at the federal level. The Agricultural Improvement Act of 2018 (the “2018 Farm Bill”), which, among other things, offered a federal definition of hemp and removed it from the list of Schedule I controlled substances, specifically carved out hemp derived products with less than 0.3% delta-9-tetrahydocannabinol (THC) on a dry weight basis, thereby allowing products that meet this definition to flood the consumer markets.

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Hacking Healthcare: Cyberattack Contingency Planning and Response

Establishing and maintaining effective systems to protect sensitive personal data and confidential business information from outside interference while also assuring that privacy interests are protected is among an organization’s highest priorities. Our security and privacy team at Epstein Becker & Green has written extensively about the guidance and best practices issued by federal and state regulatory and enforcement agencies. Execution, monitoring and continually updating these preventive practices define an organization’s first line of defense. But what happens in the event that an organization actually suffers a breach? Is there guidance that might be available, particularly to healthcare organizations, to deal with continuity and disaster planning (BC/DR) directed towards assuring resilience and recovery in the event of a potentially-disastrous cyberattack?

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Where is the Tipping Point – Comprehensive State Privacy Law Update

Connecticut becomes the fifth state to pass a comprehensive privacy law. Are you prepared for state privacy law compliance required in 2023?

Despite a shifting privacy landscape and passage of the EU’s General Data Protection Regulation (GDPR) in 2016, the United States has lagged in adopting a comprehensive Federal privacy law. Nevertheless, over the past few years, particular states have prioritized consumer privacy to address growing concern regarding the unfettered and largely unregulated collection, use and disclosure of consumer personal information.[1] Following the watershed moment created through passage of the California Consumer Privacy Act (CCPA) of 2018, an increasing number of states have followed suit to pass comprehensive privacy laws. Yet, the question remains regarding how many states must pass similar laws before the Federal government takes on the charge of passing a comprehensive privacy law.

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FTC Enforcement Highlights the Importance of Preserving Privacy in AI Development: How to Avoid AI Model Destruction

The success of an artificial intelligence (AI) algorithm depends in large part upon trust, yet many AI technologies function as opaque ‘black boxes.’ Indeed, some are intentionally designed that way. This charts a mistaken course.

Trust in AI is engendered through transparency, reliability and explainability. In order to achieve those ends, an AI application must be trained on data of sufficient variety, volume and verifiability. Given the criticality of these factors, it is unsurprising that regulatory and enforcement agencies afford particular attention to whether personally-identifiable information (“PII”) has been collected and employed appropriately in the development of AI. Thus, as a threshold matter, when AI training requires PII (or even data derived from PII), organizations need to address whether such data have been obtained and utilized in a permissible, transparent and compliant manner.

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