With telehealth surging around the globe due to the COVID-19 pandemic, the UK National Health Services has released guidance that provides a set of good practice principles for third-party partners to follow....more
2/5/2021
/ Coronavirus/COVID-19 ,
Data Protection ,
Electronic Protected Health Information (ePHI) ,
General Data Protection Regulation (GDPR) ,
Health Care Providers ,
Infectious Diseases ,
Life Sciences ,
Patient Access ,
Personal Data ,
Regulatory Agenda ,
Telehealth ,
Telemedicine ,
UK
In response to delayed EU shipments of certain COVID-19 vaccines to the European Union, the European Commission (Commission) passed on 29 January 2021 Regulation 2021/111 (Export Authorization Regulation) which is in force...more
Welcome to the August 2020 issue of our Life Sciences International Review. This issue covers new developments within Asia, Europe, and the United States in intellectual property, regulatory, pricing, and international trade,...more
8/24/2020
/ Asia ,
Coronavirus/COVID-19 ,
Digital Health ,
EU ,
Food and Drug Administration (FDA) ,
Force Majeure Clause ,
Foreign Direct Investment ,
Fraud ,
Life Sciences ,
Medical Devices ,
Over The Counter Drugs (OTC) ,
Patent Terms ,
Pharmaceutical Industry ,
Prescription Drugs
From disrupting the supply of medical devices to affecting how they are regulated and sold in the United Kingdom (UK), Brexit could carry significant implications for UK healthcare and trade....more
EU – REGULATORY -
Brexit, Notified Bodies, and Medical Devices -
The House of Commons Library published a briefing paper on June 12 on the UK’s product standards and safety marking compliance in light of Brexit. In the...more
8/20/2019
/ Anti-Kickback Statute ,
Asia ,
China ,
Competition ,
Data Privacy ,
Drug Pricing ,
EU ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Life Sciences ,
Medical Devices ,
Patents ,
Pharmaceutical Industry ,
UK Brexit
Welcome to the third issue of our European Life Sciences Review that covers some of the most critical developments in the pharmaceutical and medical technology sectors in the last month and is produced by our life sciences...more
7/16/2016
/ Anti-Competitive ,
Anti-Corruption ,
Clinical Trials ,
Data Protection ,
EU ,
EU-US Privacy Shield ,
General Data Protection Regulation (GDPR) ,
Life Sciences ,
Medical Devices ,
Mobile Health Apps ,
Off-Label Promotion ,
Pharmaceutical Industry ,
TTIP ,
UK ,
UK Brexit ,
UK Competition and Markets Authority (CMA)
Welcome to the second issue of our EU life sciences alerter that covers some of the most critical developments in the pharmaceutical and medical technology sectors in the last month and is produced by our life sciences...more
Welcome to the first issue of our EU Life Sciences Review . It is produced by our life sciences lawyers in London, Brussels, Frankfurt, Moscow, and Paris and covers some of the most critical developments in the pharmaceutical...more
2/2/2016
/ Biotechnology ,
EU ,
European Commission ,
European Court of Justice (ECJ) ,
European Food Safety Authority (EFSA) ,
General Data Protection Regulation (GDPR) ,
Hazardous Waste ,
Life Sciences ,
Orphan Drugs ,
Personalized Medicine ,
The Patent Box ,
UK ,
Unitary Patent ,
US-EU Safe Harbor Framework
With the recent ruling that the Safe Harbor programme is invalid under European law, life sciences companies will need to review their strategies when exporting patient data to the United States....more
10/12/2015
/ Binding Corporate Rules ,
Data Privacy ,
Data Protection Authority ,
Data Security ,
EU ,
EU Data Protection Laws ,
European Commission ,
European Court of Justice (ECJ) ,
Health Information Technologies ,
Informed Consent ,
International Data Transfers ,
Life Sciences ,
Medical Devices ,
Personal Data ,
Pharmaceutical Industry ,
PHI ,
Prior Express Consent ,
SCC ,
Schrems I & Schrems II ,
Third-Party ,
Umbrella Agreement ,
US-EU Safe Harbor Framework
The European Medicines Agency moves to increase EU clinical trial transparency.
The last five years have seen a sea change in the attitude of EU authorities regarding the disclosure of clinical trial results, moving from...more
8/5/2015
/ Clinical Trials ,
Confidential Information ,
Data Privacy ,
Data Protection ,
Data-Sharing ,
EU ,
Medical Research ,
New Regulations ,
Personally Identifiable Information ,
PHRMA ,
Transparency