Recent enforcement actions, audit activity, proposed rulemakings, and guidance issued by the U.S. Department of Health and Human Services (“HHS”), Office for Civil Rights (“OCR”) highlight the agency’s focus on health data...more
1/17/2025
/ Artificial Intelligence ,
Audits ,
Compliance ,
Cyber Attacks ,
Cybersecurity ,
Data Privacy ,
Data Security ,
Enforcement Actions ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OCR ,
Ransomware ,
Risk Management
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...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
Momentum is growing for a federal privacy law in the United States. A bipartisan group of House and Senate leaders have released a discussion draft of a baseline consumer data protection legislation. The American Data...more
The US Department of Health Human Services (HHS) is seeking public comments about the appropriate role of “recognized security practices” in enforcement of the HIPAA Security Rule. Congress, through an amendment to the HITECH...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
There has been a significant development in the ongoing debate regarding the scope of the authority of the Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) to issue penalties under the Health...more
As the world focuses its efforts on the right strategy to beat the coronavirus and make normal life safe again, businesses are devising and implementing a variety of measures to deal with the COVID-19 crisis which rely on the...more
5/21/2020
/ Clinical Trials ,
Cloud Computing ,
Consumer Privacy Rights ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Collection ,
Data Privacy ,
Data Protection ,
Data Security ,
Employee Privacy Rights ,
Personally Identifiable Information ,
Screening Procedures
The world is on a mission: beating the coronavirus and making normal life safe again. This is a scientific and medical challenge like no other, but our collective hope is that a viable solution will be found. In parallel,...more
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
Regulators, industry experts, and researchers provided insight into health privacy and security enforcement trends, emerging threats, and new tools at a recent conference focused on the Health Insurance Portability and...more
10/22/2019
/ Cyber Attacks ,
Cybersecurity ,
Cybersecurity Framework ,
Data Breach ,
Department of Health and Human Services (HHS) ,
Electronic Medical Records ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Breach ,
Information Technology ,
NIST ,
OCR ,
Personally Identifiable Information ,
PHI ,
Right of Access ,
Risk Assessment
Regulators provided key insights into enforcement trends and potential changes to HIPAA regulations at the 11th Annual “Safeguarding Health Information: Building Assurance Through HIPAA Security” conference in October...more
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
“The number one issue on the minds of many CEOs and boards is cyberattacks and data breaches,” said Hogan Lovells partner Marcy Wilder. In this hoganlovells.com interview, Wilder discusses three key things health sector...more
8/7/2017
/ Cyber Attacks ,
Cybersecurity ,
Data Breach ,
Data Protection ,
Hackers ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Breach ,
Information Technology ,
Personally Identifiable Information ,
Ransomware ,
Risk Management
Major companies, health care organizations and government agencies are facing a wave of cyberattacks involving ransomware that takes control of computers and denies access until a ransom is paid. These attacks are occurring...more