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Vital Signs: Digital Health Law Update | Spring 2024

Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on recent developments in the U.S. Food and Drug Administration's ("FDA") regulatory...more

FDA Proposes Updated Guidance Concerning Cybersecurity of Medical Devices

The U.S. Food and Drug Administration ("FDA") has proposed updated guidance, intended to assist individuals in meeting the cybersecurity requirements for FDA medical device submissions....more

California Proposes CCPA Amendments to Further Protect Children's Privacy

Proposed amendments to the California Consumer Privacy Act would require businesses to obtain opt-in consent prior to collecting, selling, sharing, using, or disclosing a minor's personal information....more

HHS Enters Into First-Ever Ransomware Resolution Agreement and Corrective Action Plan

The U.S. Department of Health and Human Services ("HHS") Office of Civil Rights ("OCR") has entered into its first settlement of potential Health Insurance Portability and Accountability Act ("HIPAA") violations arising out...more

New York Governor Proposes Stringent Cybersecurity Regulations for Hospitals

New York is the first state to propose cybersecurity requirements for all hospitals operating in the state to address patient safety and other cybersecurity related issues....more

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