- On 26 March 2025, the European Health Data Space (EHDS) Regulation entered into force. The regulation establishes a comprehensive framework for health-data sharing and access in the EU, with the dual aim of supporting the...more
6/26/2025
/ Compliance ,
Data Privacy ,
Data Security ,
Data-Sharing ,
Electronic Protected Health Information (ePHI) ,
EU ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Intellectual Property Protection ,
Life Sciences ,
Noncompliance ,
Personal Data ,
Regulatory Agenda ,
Regulatory Requirements ,
Shareholders
Executive Summary -
The EU Data Act, whose requirements apply from 12 September 2025, establishes new rights for businesses and consumers to access data they generated using “connected devices,” limiting the exclusive...more
6/24/2025
/ Cloud Computing ,
Competition ,
Contract Terms ,
DATA Act ,
Data Privacy ,
Data Protection ,
Data-Sharing ,
Enforcement ,
EU ,
General Data Protection Regulation (GDPR) ,
New Legislation ,
Regulatory Requirements ,
UK
The EU’s Digital Operational Resilience Act (DORA) becomes binding on 17 January 2025. As the compliance deadline approaches, EU financial regulators (ESAs) have issued a flurry of statements on the act, including:
- An...more
1/6/2025
/ Cybersecurity ,
Digital Operational Resilience Act (DORA) ,
EIOPA ,
Enforcement ,
EU ,
European Banking Authority (EBA) ,
European Supervisory Authorities (ESAs) ,
Financial Institutions ,
Financial Services Industry ,
Information and Communication Technology (ICT) ,
Investment Management ,
Policies and Procedures ,
Risk Management
The deadline for EU countries to transpose the expanded cybersecurity directive, NIS 2, into national law is 17 October 2024, but the implementation status varies significantly from country to country. Some of the member...more
10/14/2024
/ Corporate Governance ,
Cybersecurity ,
Data Privacy ,
Data Protection ,
Data Security ,
Deadlines ,
EU ,
National Security ,
Popular ,
Risk Management ,
Technology Sector
Valuable insights into the measures European regulators expect businesses to take to protect data privacy can be found in a report from the European Data Protection Board (EDPB) summarizing decisions under the EU’s General...more
4/15/2024
/ Data Breach ,
Data Controller ,
Data Protection ,
Data Security ,
Enforcement ,
EU ,
European Court of Justice (ECJ) ,
European Data Protection Board (EDPB) ,
Firewalls ,
General Data Protection Regulation (GDPR) ,
Passwords ,
Professional Regulators
Both the EU and Germany are taking significant steps to accelerate digitalization in the health sector and facilitate the exchange and use of health data for research and innovation purposes.
They aim to improve...more
4/4/2024
/ Analytics ,
Artificial Intelligence ,
Cybersecurity ,
Data Protection ,
Data-Sharing ,
Digital Health ,
EU ,
Germany ,
Healthcare ,
Life Sciences ,
Machine Learning ,
Pharmaceutical Industry ,
Popular ,
Privacy Laws ,
Research and Development
On January 31, 2024, the European Commission (EC) adopted the first of a series of initiatives to harmonize cybersecurity certification across the EU: the European Cybersecurity Scheme on Common Criteria (EUCC).
While EUCC...more