On May 30, 2024, the FTC published amendments to its Health Breach Notification Rule (“HBNR” or “Rule”) in the Federal Register, memorializing the Rule’s expanded scope that now explicitly includes direct-to-consumer health...more
Adding to the growing trend of policymakers interested in regulating health and wellness data, last week U.S. Senator Bill Cassidy requested stakeholder feedback to help identify solutions to modernize HIPAA and ensure all...more
9/12/2023
/ Biometric Information ,
Consumer Privacy Rights ,
Cybersecurity ,
Data Collection ,
Data Privacy ,
Data Protection ,
Department of Health and Human Services (HHS) ,
Health Information Technologies ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Patient Privacy Rights ,
Personally Identifiable Information ,
Privacy Laws ,
Regulatory Agenda
This week the U.S. Department of Health and Human Services, the agency responsible for HIPAA enforcement, announced the formation of three new divisions within the Office for Civil Rights (“OCR”). The new divisions –...more
Health companies cannot use online tracking technologies like other consumer organizations. This refrain, repeated frequently by regulators, litigants and the media in recent months, may now have found its clearest voice in...more
The Federal Trade Commission (FTC) recently has signaled its intent to inject new life into a longstanding but rarely triggered rule governing health breach notifications for non-HIPAA-covered health records. Specifically,...more
2/28/2022
/ Breach Notification Rule ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Protection ,
Data Security ,
Digital Health ,
Federal Trade Commission (FTC) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Popular
A new Policy Statement from the US Federal Trade Commission places companies that offer consumer-facing health apps and connected health and wellness devices on notice that they may be covered by a Health Breach Notification...more
10/6/2021
/ American Recovery and Reinvestment Act ,
Application Programming Interface (APIs) ,
Breach Notification Rule ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Federal Trade Commission (FTC) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Mobile Health Apps ,
Policy Statement ,
Popular
Consent is newly defined by the California Privacy Rights Act (CPRA). While this new definition of consent—which highlights specific, informed, and freely-given actions—closely aligns with the European Union’s General Data...more
4/23/2021
/ California Privacy Rights Act (CPRA) ,
Consumer Privacy Rights ,
Cybersecurity ,
Data Management ,
Data Privacy ,
Data Protection ,
General Data Protection Regulation (GDPR) ,
Information Governance ,
Personal Data ,
Popular ,
Prior Express Consent
Companies in the life sciences and health care industry, like most companies, navigated unparalleled challenges in 2020. But unlike other industries, they had to do so while simultaneously facing the biggest challenge of all...more
On June 1, The California Attorney General (CA AG) submitted the final text of the CCPA regulations to the California Office of Administrative Law (OAL) for approval. ...more
6/2/2020
/ California Consumer Privacy Act (CCPA) ,
Consumer Privacy Rights ,
Cybersecurity ,
Data Collection ,
Data Management ,
Data Privacy ,
Data Protection ,
Information Governance ,
Personal Data ,
Personally Identifiable Information ,
Rulemaking Process ,
State and Local Government ,
State Attorneys General
On March 11, The California Attorney General (CA AG) released a second set of modifications to the proposed regulations implementing the California Consumer Privacy Act (CCPA)....more
3/13/2020
/ California Consumer Privacy Act (CCPA) ,
Consumer Privacy Rights ,
Cybersecurity ,
Data Collection ,
Data Management ,
Data Privacy ,
Data Protection ,
Digital Service Providers ,
Information Governance ,
Opt-Outs ,
Personal Data ,
Personally Identifiable Information ,
Privacy Laws ,
Regulatory Agenda ,
Regulatory Requirements ,
Right to Delete ,
Rulemaking Process ,
State and Local Government ,
State Attorneys General
We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more
2/26/2020
/ 3D Printing ,
AIDS ,
Analytics ,
Artificial Intelligence ,
Biosimilars ,
Biotechnology ,
Blockchain ,
California Consumer Privacy Act (CCPA) ,
Cyber Threats ,
Cybersecurity ,
Data Breach ,
Department of Defense (DOD) ,
Digital Health ,
Drug Distribution ,
Drug Pricing ,
EU ,
Federal Funding ,
Food and Drug Administration (FDA) ,
General Data Protection Regulation (GDPR) ,
Health Technology ,
HIV ,
Incident Response Plans ,
Intellectual Property Protection ,
Life Sciences ,
Medical Device Data System ,
Medical Devices ,
Medical Software ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
PHI ,
Prescription Drugs ,
Procurement Guidelines ,
Regulatory Standards ,
Research and Development ,
Right to Try ,
Robotics ,
Supply Chain ,
Telehealth
On October 17, 2019, the Hogan Lovells Privacy and Cybersecurity team discussed key elements of the California Attorney General’s proposed regulations implementing certain provisions of the California Consumer Privacy Act...more
11/5/2019
/ California Consumer Privacy Act (CCPA) ,
Consumer Privacy Rights ,
Cybersecurity ,
Data Collection ,
Data Deletion ,
Data Management ,
Data Privacy ,
Data Protection ,
Information Governance ,
Opt-In ,
Opt-Outs ,
Personal Data ,
Personally Identifiable Information ,
Privacy Laws ,
Proposed Regulation ,
Regulatory Agenda ,
Right to Delete ,
Rulemaking Process ,
State and Local Government
On October 10, California Attorney General Xavier Becerra (CA AG) released proposed regulations to implement certain provisions of the California Consumer Privacy Act (CCPA). The CA AG also released a Notice of Proposed...more
10/14/2019
/ California Consumer Privacy Act (CCPA) ,
Consumer Privacy Rights ,
COPPA ,
Cybersecurity ,
Data Collection ,
Data Privacy ,
Data Protection ,
Information Sharing ,
Non-Discrimination Rules ,
NPRM ,
Personal Data ,
Personally Identifiable Information ,
Privacy Laws ,
Proposed Regulation ,
Regulatory Agenda ,
Rulemaking Process ,
State and Local Government ,
State Attorneys General
This is the sixth installment in Hogan Lovells’ series on the California Consumer Privacy Act.
The California Consumer Privacy Act of 2018 (CCPA) adds another set of privacy requirements for health and life sciences...more
10/8/2018
/ California Consumer Privacy Act (CCPA) ,
Clinical Trials ,
CMIA ,
Consumer Privacy Rights ,
Cybersecurity ,
Data Collection ,
Data Privacy ,
Data Protection ,
Exemptions ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
Nonprofits ,
Personally Identifiable Information ,
Privacy Laws
Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical...more
4/4/2018
/ 3D Printing ,
Acquisitions ,
Artificial Intelligence ,
Biologics ,
Biosimilars ,
Biotechnology ,
Blockchain ,
Cyber Attacks ,
Cybersecurity ,
Data Breach ,
Digital Health ,
Distributed Ledger Technology (DLT) ,
Drug Pricing ,
Emerging Markets ,
EU ,
General Data Protection Regulation (GDPR) ,
Generic Drugs ,
Innovation ,
Life Sciences ,
Medical Reimbursement ,
Mergers ,
Over The Counter Derivatives (OTC) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Private Equity ,
Regulatory Oversight ,
Supply Chain ,
Transfer Pricing ,
UK Brexit ,
Yates Memorandum