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Articles by Sam Siegfried
NY Assembly Passes Restrictive Health Information Privacy Act
New York Assembly Passes Restrictive Health Information Privacy Act On January 22, 2025, the New York Assembly passed Senate Bill S929, known as the New York Health Information Privacy Act. If enacted, it will impose strict requirements on entities that handle health or wellness-related consumer data. Read more here.
New York Assembly Passes Restrictive Health Information Privacy Act
On January 22, 2025, the New York Assembly passed Senate Bill S929, known as the New York Health Information Privacy Act. If enacted, it will impose strict requirements on entities that handle health or wellness-related consumer data.
New York Passes Restrictive Health Information Privacy Act | JD Supra
On January 22, 2025, the New York Assembly passed Senate Bill S929, titled the New York Health Information Privacy Act (New York HIPA). The act is now on its way to Governor Kathy Hochul for her signature. If signed into law, New York HIPA will impose strict requirements on entities that handle health or wellness-related consumer data and shares a number of similarities with Washington state’s My Health My Data Act (MHMDA), another far-reaching consumer health data privacy law.
Updated Mandatory Disclosure Requirements For Colorado Mental Health Providers Go Into Effect
On August 1, 2024, Colorado legislation took effect amending the mandatory disclosures that mental health providers must make to their clients under state law. Providers of mental health services in Colorado should take note of the new legislation and review their existing patient disclosure notices to ensure compliance. Colorado law requires mental health providers to disclose certain information in writing during initial client contact.
Updated Mandatory Disclosure Requirements for Colorado Mental Health Providers Go into Effect
On August 1, 2024, Colorado legislation took effect amending the mandatory disclosures that mental health providers must make to their clients under state law. Providers of mental health services in Colorado should take note of the new legislation and review their existing patient disclosure notices to ensure compliance. Colorado law requires mental health providers to disclose certain information in writing during initial client contact.
Real-World Data Back in the Spotlight at FDA
On July 25, 2024, the US Food and Drug Administration (FDA) announced the release of a final version of its Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products Guidance.
How to Prepare for New State Health Privacy Laws
Key Takeaways | How to Prepare for New State Health Privacy Laws New state privacy laws regulating health data impose significant obligations and heightened litigation and regulatory risks. During this webinar, Elliot Golding and Sam Siegfried discussed how these laws apply, what they require, and practical tips to implement and operationalize compliance. Access key takeaways and webinar replay.
[Webinar] How to Prepare for New State Health Privacy Laws - March 12th, 3:00 pm - 4:00 pm EDT | JD Supra
New state privacy laws regulating health data impose significant obligations and heightened risks. In addition to existing laws in California, Colorado and other states, Washington State’s My Health My Data Act and Nevada’s Consumer Health Data Privacy Law take effect in March 2024 and will require new or updated privacy notices, enhanced consent and many other compliance steps.
Landmark Executive Order on AI: What Does It Mean for Healthcare?
On October 30, 2023, the White House released a long-awaited Executive Order (EO) on the “Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence.” The EO acknowledges the transformative potential of AI while highlighting many known risks of AI tools and systems. It directs a broad range of actions around new standards for AI that will impact many sectors, and it articulates eight guiding principles and priorities to govern the development and use of AI (outlined below).
FDA Issues Final Guidance on Informed Consent in Clinical Investigations | JD Supra
On August 15, 2023, the US Food and Drug Administration (FDA) finalized Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (final guidance). This document finalizes, with new examples and limited updates and modifications, the FDA’s draft guidance entitled Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors, issued on July 15, 2014.
FDA Issues Final Guidance on Informed Consent in Clinical Investigations
On August 15, 2023, the US Food and Drug Administration (FDA) finalized Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (final guidance). This document finalizes, with new examples and limited updates and modifications, the FDA’s draft guidance entitled Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors, issued on July 15, 2014.
Special Report - Decoding Genomic Data Security: Lessons from FTC’s Vitagene Enforcement and the NIST CSF Profile for Genomic Data | JD Supra
Remarkable progress in DNA and RNA sequencing have democratized the generation and analysis of genomic data across diverse industry sectors, including biopharmaceutical research, healthcare, consumer ancestry, law enforcement, agriculture and wellness testing. However, these advances have simultaneously escalated cybersecurity risks associated with the collection, processing, and maintenance of genomic data.
Decoding Genomic Data Security: Lessons from FTC’s Vitagene Enforcement and the NIST CSF Profile for Genomic Data
To view this article you need a PDF viewer such as Adobe Reader. If you can't read this PDF, you can view its text here. Go back to the PDF . USA August 15 2023 INTRODUCTION Remarkable progress in DNA and RNA sequencing have democratized the generation and analysis of genomic data across diverse industry sectors, including biopharmaceutical research, healthcare, consumer ancestry, law enforcement, agriculture and wellness testing.
FDA Issues Draft Guidance on Decentralized Clinical Trials for Drugs, Biological Products and Devices
Over the past few years, the life sciences and healthcare industries have experienced a notable increase in focus and interest in decentralized clinical trials (DCTs), in which some or all of the trial-related activities occur at locations other than traditional in-person clinical trial sites, along with the technologies and other offerings that typically support them.
Washington State Legislature Passes My Health My Data Act
The My Health My Data Act in Washington State (the Act) is expected to be signed into law by Governor Jay Inslee this year, after being passed by both the Washington Senate and House in different versions. Unlike recent state privacy laws, the Act specifically targets consumer health data that is not covered by the Health Insurance Portability and Accountability Act (HIPAA).
Washington Legislature Passes My Health My Data Act | JD Supra
April 14, 2023 Austin Mooney, David Saunders, Sam Siegfried, Alya Sulaiman McDermott Will & Emery + Follow x Following x Following - Unfollow Contact To embed, copy and paste the code into your website or blog: Washington State’s My Health My Data Act (the Act), which is working its way through the reconciliation process after the Washington Senate and House passed different versions of the Act, is ultimately expected to be signed into law by Governor Jay Inslee this year.
Washington Legislature Passes My Health My Data Act
Washington State’s My Health My Data Act (the Act), which is working its way through the reconciliation process after the Washington Senate and House passed different versions of the Act, is ultimately expected to be signed into law by Governor Jay Inslee this year. This privacy law differs from other recent state privacy legislation in that it is singularly focused on non-Health Insurance Portability and Accountability Act (HIPAA)-regulated consumer health data.
FDA issues draft predetermined change control plan for machine-learning-enabled device software functions
(April 26, 2023) - McDermott Will & Emery attorneys Vernessa T. Pollard, Anisa Mohanty, Alya Sulaiman and Sam Siegfried discuss the Food and Drug Administration's draft guidance on artificial intelligence and machine learning-enabled device software functions.
FTC Issues Policy Statement Expanding Interpretation of Health Breach Notification Rule’s Scope | JD Supra
On September 15, 2021, the Federal Trade Commission (FTC) voted 3–2 along party lines (with Republican commissioners dissenting) to issue a policy statement announcing an expansive interpretation of the FTC’s Health Breach Notification Rule, 16 CFR Part 318 (the Rule).
Temporary Relief for Debt Collectors: 11th Circuit Withholds Hunstein Mandate | JD Supra
On June 14, 2021, the US Court of Appeals for the 11th Circuit issued an order withholding issuance of the mandate for its April 21, 2021, holding in Hunstein v. Preferred Collection and Management Services, Inc.
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