We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, we present a timely discussion about increasing litigation and...more
12/16/2024
/ Artificial Intelligence ,
Breach Notification Rule ,
Center for Drug Evaluation and Research (CDER) ,
Clinical Trials ,
Data Breach ,
Data Protection ,
Digital Health ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Information Technology ,
Life Sciences ,
Pharmaceutical Industry ,
PHI ,
Prescription Drugs ,
Telehealth ,
Telemedicine
New York recently passed new cybersecurity regulations for hospitals licensed in New York to enhance patient safety and cybersecurity....more
11/7/2024
/ Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Protection ,
Data Security ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Facilities ,
Hospitals ,
Information Technology ,
New Legislation ,
New York ,
Personally Identifiable Information ,
PHI ,
Regulatory Reform
On June 20, 2024, a U.S. federal district court held, in a suit brought by Jones Day, that the Department of Health and Human Services ("HHS") had misapplied the Health Insurance Portability and Accountability Act ("HIPAA")...more
8/2/2024
/ Confidential Information ,
Covered Entities ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
Medical Records ,
New Guidance ,
PHI
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
7/22/2024
/ Algorithms ,
Artificial Intelligence ,
Cybersecurity ,
Data Protection ,
Department of Justice (DOJ) ,
Digital Health ,
Food and Drug Administration (FDA) ,
General Data Protection Regulation (GDPR) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Innovative Technology ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Personal Data ,
Pharmacies ,
Popular ,
Telemedicine
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
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on HHS' recent final rule on the confidentiality of substance use disorder patient...more
3/20/2024
/ Consent ,
Data Privacy ,
Data Security ,
DEA ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Life Sciences ,
Medical Devices ,
OCR ,
Personal Information ,
Popular ,
Risk Management ,
Telehealth
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
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
12/6/2023
/ Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Protection ,
Data Security ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Violations ,
Hospitals ,
Life Sciences ,
OCR ,
Ransomware
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
12/1/2023
/ Chief Information Security Officer (CISO) ,
Cyber Threats ,
Cybersecurity ,
Data Protection ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Facilities ,
Hospitals ,
New York ,
NYDFS ,
Patient Privacy Rights ,
Popular ,
Proposed Regulation ,
Regulatory Agenda ,
Regulatory Reform
In a large-scale push, the Federal Trade Commission advises companies advertising their health- and wellness-related products against making unsubstantiated product claims....more