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Oct 29, 2024 | 
jdsupra.com | Melissa Bianchi |Alyssa Golay |Jessica Robinson Hanna
AB 3030 requires health facilities, clinics, physician’s offices, or offices of a group practice to present prominent disclosures about their use of generative AI to generate written or verbal patient communications pertaining to patient clinical information, effective January 1, 2025. Depending on the specific form of the communication, the “use of generative AI” disclaimer must be provided either at the beginning of the communication or throughout the communication.
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Oct 28, 2024 | 
hoganlovells.com | Marcy Wilder |Melissa Bianchi |Alyssa Golay |Jessica Robinson Hanna
News
Recent actions by state and federal lawmakers are trending toward increased regulation and oversight of uses of AI in health care. From patient communications to medical necessity determinations and more, legislators and regulators are focused and willing to act on the use of AI in the health care industry. Several of the flurry of AI-related laws signed by California Governor Newsom on September 28, 2024, will impact health care companies.
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Oct 28, 2024 | 
lexology.com | Marcy Wilder |Melissa Bianchi |Alyssa Golay |Jessica Robinson Hanna
Recent actions by state and federal lawmakers are trending toward increased regulation and oversight of uses of AI in health care. From patient communications to medical necessity determinations and more, legislators and regulators are focused and willing to act on the use of AI in the health care industry. Several of the flurry of AI-related laws signed by California Governor Newsom on September 28, 2024, will impact health care companies.
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May 8, 2024 | 
jdsupra.com | Ken Choe |Alyssa Golay |James Huang
In 2022, OCR and CMS issued a Notice of Proposed Rulemaking (NPRM) to reinterpret Section 1557 of the ACA, which prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in, among other things, a health program or activity for which any part receives federal financial assistance.
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Apr 4, 2024 | 
jdsupra.com | Melissa Bianchi |Alyssa Golay |Ashley Grey
Since 1995, FDA has received 300 submissions for drugs and biological products with AI components and more than 700 submissions for AI-enabled devices, according to FDA Commissioner Robert Califf, MD, in a recent FDA Voices article. These submissions involve integrating AI in various contexts, including drug discovery and repurposing, enhancing clinical trial design elements, dose optimization, endpoint/biomarker assessment, and postmarket surveillance.
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Apr 2, 2024 | 
lexology.com | Melissa Bianchi |Blake Wilson |Alyssa Golay |Ashley Grey
The Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), and Office of Combination Products (OCP) recently published a joint discussion paper on artificial intelligence (AI) and medical products that aims to provide greater transparency on how FDA’s medical product Centers are collaborating to safeguard public health, while at the same time fostering...
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Mar 12, 2024 | 
jdsupra.com | Alyssa Golay |Marcy Wilder
In September, Senator Cassidy issued a request to help identify solutions to modernize HIPAA and ensure all U.S. health data is properly safeguarded. On February 21, his office released a report “outlining ways to improve privacy protections for Americans’ crucial health data” based on feedback from trade associations, hospitals, electronic health record vendors, health technology companies, and think tanks.
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Jan 19, 2024 | 
jdsupra.com | Mark Brennan |Alyssa Golay |Paige Papandrea
Regulators and legislators are increasingly pursuing additional privacy and other protections for sensitive data, including consumer health data. Since Washington’s passage of its My Health My Data Act on April 27, 2023, Nevada also passed a consumer health data privacy law, and Connecticut amended its consumer data privacy act to impose similar transparency requirements and restrictions on the use and disclosure of consumer health data.
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Jan 18, 2024 | 
lexology.com | Mark Brennan |Marcy Wilder |Alyssa Golay
Adding to the growing list of heightened privacy and data protection requirements imposed on consumer health data and other categories of sensitive personal data, the Washington Attorney General recently updated its guidance on Washington’s My Health My Data Act’s notice requirements, explicitly requiring a standalone consumer health data privacy policy with its own link on websites and mobile apps.
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Sep 12, 2023 | 
jdsupra.com | Melissa Bianchi |Alyssa Golay |Marcy Wilder
General privacy considerations (What is health data? What entities should be accountable for handling health data?) Health information under HIPAA (Should Congress update or expand HIPAA?) Collection and sharing of health data (When should consent be required?
