The National Institutes of Health has issued a request for information (RFI) on its Genomic Data Sharing (GDS) Policy to help ensure it keeps pace with the evolving genomic research landscape. The RFI will help inform...more
States continue to enact laws targeting the protection of genetic data with two important developments in California and Florida. California’s Genetic Information Privacy Act (“GIPA”), which came into effect on January 1,...more
This morning, the U.S. House passed drug pricing legislation as part of the Build Back Better Act (BBBA) (specifically the Rules Committee version available here and the manager’s amendments available here). In prelude to...more
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
The U.S. House of Representatives is considering dueling proposals related to drug pricing under Medicaid and Medicare, including the Republican-led H.R. 19, the “Lower Costs, More Cures Act of 2021” and a reintroduced...more
4/26/2021
/ Biden Administration ,
Critical Infrastructure Sectors ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Healthcare Reform ,
Legislative Agendas ,
Medicaid ,
Medicaid Drug Rebate Program ,
Medicare ,
Medicare Part D ,
Patient Access ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda
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 February 2, Hogan Lovells partners Melissa Bianchi, David Horowitz, and George Ingham presented a webinar to the Biotechnical Innovation Organization (BIO) on “What Biotech Employers Need to Know about COVID Vaccines and...more
2/16/2021
/ Biotechnology ,
Coronavirus/COVID-19 ,
Disability Discrimination ,
Employee Rights ,
Employer Liability Issues ,
Employment Policies ,
Health and Safety ,
Infectious Diseases ,
Life Sciences ,
Pharmaceutical Industry ,
Vaccinations ,
Workplace Safety
HIPAA Privacy Rule changes that have the potential to significantly impact patients, covered entities, and business associates were proposed by the Department of Health and Human Services (HHS) in a Notice of Proposed...more
On November 20, 2020, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) finalized its previously abandoned 2019 proposal to exclude certain rebates paid by drug manufacturers from the...more
11/25/2020
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Healthcare Reform ,
MCOs ,
Medicaid Drug Rebate Program ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
Safe Harbors ,
Stark Law
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 April 8, the U.S. Department of Health and Human Services’ (HHS) Office for Human Research Protections (OHRP) issued guidance discussing how HHS human subjects protection regulations....more
In response to the COVID-19 pandemic, the U.S. Congress, the Centers for Medicare and Medicaid Services (CMS), many state legislatures and state Medicaid programs, and private payers have implemented significant changes to...more
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
Washington State is already shaping up as a center of state privacy legislation for 2020.
Last year, SB 5376 (also known as the Washington Privacy Act, or WPA) gained significant traction in the legislature, passing the...more
1/14/2020
/ Biometric Information ,
California Consumer Privacy Act (CCPA) ,
Consumer Privacy Rights ,
Data Collection ,
Data Privacy ,
Data Protection ,
Facial Recognition Technology ,
General Data Protection Regulation (GDPR) ,
Legislative Agendas ,
Opt-Outs ,
Personal Data ,
Personally Identifiable Information ,
Portability ,
Proposed Legislation ,
Right to Delete ,
State and Local Government
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
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
3/18/2019
/ Artificial Intelligence ,
Asia ,
Biologics ,
Biotechnology ,
Data Breach ,
Digital Health ,
Information Technology ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Supply Chain
In a significant step towards implementing its American Patients First blueprint for lowering prescription drug prices and patient out-of-pocket costs, the Trump administration has proposed a series of changes to the...more
2/11/2019
/ Anti-Kickback Statute ,
Comment Period ,
Drug Pricing ,
Health Insurance ,
Incentives ,
Life Sciences ,
Managed Care Contracts ,
Medicaid ,
Medicare Part D ,
Out-of-Pocket Expenses ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Popular ,
Prescription Drugs ,
Rebates ,
Regulatory Agenda ,
Safe Harbors ,
Trump Administration
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
On May 11, 2018, President Trump and Department of Health and Human Services (HHS) Secretary Alex Azar delivered highly anticipated speeches regarding the administration's plan to reduce drug prices.
...more
5/15/2018
/ Biosimilars ,
Comment Period ,
Competition ,
Drug Pricing ,
Life Sciences ,
Medicare Part B ,
Medicare Part D ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Oversight ,
Section 340B ,
Trump Administration
On April 9, 2018, the Centers for Medicare & Medicaid Services (CMS) released the Benefit and Payment Parameters final rule for 2019 (2019 Payment Notice) applicable to qualified health plans (QHPs) offered on health...more
On April 2, 2018, the Centers for Medicare & Medicaid Services (CMS) released a final rule to revise regulations and clarify program requirements within the Medicare Advantage (MA) and the Prescription Drug Benefit (Part D)...more
4/9/2018
/ Biologics ,
Biosimilars ,
Cooperative Compliance Regime ,
Final Rules ,
Generic Drugs ,
Medicare Advantage ,
Medicare Part D ,
Pharmacies ,
Rebates ,
Regulatory Oversight ,
Star Ratings ,
Uniformity
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