2024 was a transformative year for the products law landscape, marked by sweeping regulatory shifts, emerging trends, and heightened compliance challenges. These developments are reshaping industries worldwide and will...more
In the EU, the AI Act has been approved, carrying significant implications for medical device, technology, and pharmaceutical firms. In the US, there is no comprehensive federal AI legislation, but at least 45 states have...more
Artificial intelligence (AI) is transforming the health care landscape, from diagnostics to drug development and clinical trials. As AI technologies rapidly evolve, global regulators face the complex task of regulating AI to...more
With the initiative “Adapting liability rules to the digital age and circular economy” this summer, the EU has taken another step towards a revision of the Product Liability Directive 85/374/EEC (the “Directive”). Since...more
In recent years, AI has become a buzzword in life sciences and health care as the technology has developed to create applications from drug discovery to diagnostics to therapeutics. Most recently, AI has been used in the...more
Life Sciences and Health Care Horizons virtual event series -
The fast pace of innovation in the life sciences and health care industry has reached an all-time high in 2020 as the industry grapples with the new reality of...more
11/17/2020
/ Artificial Intelligence ,
Coronavirus/COVID-19 ,
Diagnostic Tests ,
Digital Health ,
Health Care Providers ,
Health Technology ,
Infectious Diseases ,
Innovation ,
Life Sciences ,
Pharmaceutical Industry ,
Physicians ,
Research and Development ,
Webinars
In May 2020, the European Parliament’s Committee on Legal Affairs took the initiative and published a draft report with recommendations to the Commission on a civil liability regime for artificial intelligence (AI) (the Draft...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
We are excited to bring you the latest issue of our International Products Law Review with insights and updates on all aspects of products law. In this issue, we explore the trustworthiness of AI, a consumer whistleblowing...more
11/1/2019
/ Appeals ,
Artificial Intelligence ,
Class Action ,
Court of Justice of the European Union (CJEU) ,
Cybersecurity ,
EU ,
Evidentiary Standards ,
Global Market ,
Medical Devices ,
Punitive Damages ,
Regulatory Agenda ,
Restaurant Industry ,
Retail Market ,
UK ,
Whistleblowers
It's been a year since the European Commission published its Fifth Report on the application of the European Product Liability Directive (the "Directive") and set up expert panels to develop its thinking on next policy steps....more
6/4/2019
/ Algorithmic Trading ,
Artificial Intelligence ,
Blockchain ,
Connected Items ,
Disruptive Technology ,
Driverless Cars ,
EU ,
EU Directive ,
European Commission ,
Regulatory Oversight ,
Regulatory Standards ,
Strict Liability
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
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