The California Attorney General’s Office (AG) unsurprisingly takes an expansive view of how the development, sale, and use of artificial intelligence technology (AI) in healthcare could lead to potential violations of existing California laws. In a recent legal advisory the AG highlights specific areas healthcare organizations should focus on as they develop, train, improve, and deploy AI in connection with patients, plan members, and their data.

In particular, the advisory identifies AI risk hot spots that may trigger certain state consumer protection, anti-discrimination, and privacy/autonomy laws, as described further below.Continue Reading California AG Explains How Laws May Apply to AI in Healthcare

The U.S. Department of Health and Human Services (“HHS”), through its Office for Civil Rights (“OCR”), recently issued a “Dear Colleague” letter, Ensuring Nondiscrimination Through the Use of Artificial Intelligence (“AI”) and Other Emerging Technologies, which emphasizes the importance of fairness and equity in AI use in patient care decision support tools (e.g., clinical algorithms and predictive analytics) in connection with certain health programs and activities. While not the law, HHS continues to provide its views about using AI in health care.  See our prior post about another HHS publication that organizations can use as guidance. Specifically, the letter emphasizes the importance of complying with the federal nondiscrimination requirements of Section 1557 of the Affordable Care Act (“Section 1557”).

OCR’s letter confirms that it will enforce Section 1557’s nondiscrimination protections to the use of AI (effective from July 5, 2024) and it will require organizations that participate in certain regulated programs and activities to identify and mitigate risks of unlawful discrimination when using AI (effective on May 1, 2025). We highlight OCR’s guidance on these two enforcement objectives related to Section 1557 below.Continue Reading HHS Recent Guidance on AI Use in Health Care

The Department of Health and Human Services (HHS) released a final rule today governing federal protections for health care workers exercising their right to nondiscrimination on the basis of conscience objections.

The rule, entitled, Safeguarding the Rights of Conscience as Protected by Federal Statutes, is scheduled to be published in the Federal Register on Thursday, January 11 and will take effect on March 11, 2024. The rule effectively repeals the majority of a Trump-era rule that was blocked by federal court orders before it even went into effect.

The new rule reinstates provisions of an Obama-era rule that placed the Office for Civil Rights (OCR), the HHS office that handles nondiscrimination enforcement, in charge of coordinating complaints for violations of the conscience protections of various federal laws. The rule also implements a voluntary notice provision that establishes an industry best practice to alert employees to their rights under the laws.Continue Reading HHS Repeals Most of 2019 Health Care Conscience Protection Rule

In December 2022, the New York City Council introduced the Secure Jobs Act. The Act attempts to redefine the long-established system of at-will employment by requiring New York City employers to provide “just cause” before firing an employee. The Act builds on December 2020 legislation that imposed similar restrictions within the fast food industry

As the health care industry as a whole comes to grips with the fallout from the U.S. Supreme Court’s decision to overturn Roe v. Wade in Dobbs v. Jackson Women’s Health, here at Reed Smith we have formed a Reproductive Health Working Group to bring expertise from the across our many specialty areas to help our clients to prepare for the post-Dobbs reality.

To that end, we have generated a series of “unanswered questions” client updates to reflect the issues that a Roe reversal may have for the health care industry. Earlier posts on this blog have shared the parts of that series that focused on pharmacieshealth care providers, and fertility practices, and employee benefit plans.

The Working Group has put together two new updates to branch into the employment and privacy areas.Continue Reading Unanswered Questions on Privacy and Employment from Supreme Court Overturn of Roe v. Wade

By October 16, 2016, all health programs and activities receiving federal financial assistance from the Department of Health and Human Services (HHS), those administered by HHS, and Health Insurance Marketplaces (Covered Entities), must be in compliance with the final pieces of the final rule issued by the Office for Civil Rights (OCR) issued May 18

The Department of Health and Human Services (HHS) has published a final rule implementing Section 1557 of the Affordable Care Act (ACA), which prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in any health program or activity that receives financial assistance from or is administered by HHS or