On 26 June 2024, Hogan Lovells, in collaboration with Buen Crypto, hosted an event to discuss imminent implications for firms who will be subject to the Markets in Crypto Asset Regulation (MiCA) due to come into force from 30...more
The European Union Cloud Services Scheme (“EUCS”) is a certification framework for cloud services introduced under the EU Cybersecurity Act. Currently still under consultation, the EUCS, once finalised, will be implemented by...more
On 28 November 2022, the European Council adopted the Digital Operational Resilience Act (“DORA”), concluding the final step in the EU legislative approval process and on 16 January 2023 DORA entered into force. DORA will be...more
The outlook for 2023 looks uncertain, following another tumultuous year. The collapse of a number of large cryptocurrency exchanges has shone another spotlight on the digital asset market. The financial system’s resilience...more
On 8 June 2022, HM Treasury published its policy statement, outlining a proposal to regulate third parties to financial services and financial market infrastructure firms (“Firms”). This proposal comes shortly after the EU,...more
On 11 May 2022, the European Council announced in a press release, that it had reached a provisional agreement with the European Parliament on DORA, a piece of legislation designed to strengthen the operational resilience of...more
The European Central Bank (ECB) has just kicked off an “investigation phase” to explore different options for the digital Euro. This phase of detailed consideration for a European version of a Central Bank Digital Currency...more
In recent years, operational resilience has come under the spotlight of financial regulators globally, leading to a proliferation of new regulation. The sheer number of publications on this topic can be confusing for...more
3/25/2021
/ Capital Requirements ,
Cloud Computing ,
EIOPA ,
EU ,
European Securities and Markets Authority (ESMA) ,
Financial Services Industry ,
Information and Communication Technology (ICT) ,
MiFID II ,
Payment Services Directive ,
Regulatory Agenda ,
Solvency II ,
UK Brexit
The European Commission has published a proposed Regulation on digital operational resilience within the financial services sector in the EU. This will replace and harmonise existing guidance in relation to ICT and security...more
10/20/2020
/ Cyber Threats ,
Digital Currency ,
EIOPA ,
ENISA ,
EU ,
European Banking Authority (EBA) ,
European Commission ,
European Securities and Markets Authority (ESMA) ,
Financial Services Industry ,
Legislative Agendas ,
Risk Management ,
Third-Party Risk
An advisory committee to EU institutions has issued an opinion on blockchain and the EU single market, advising the European Commission on potential next steps, including launching a "comprehensive" blockchain initiative,...more
3/5/2020
/ Anti-Corruption ,
Blockchain ,
Competition ,
Cross-Border ,
Cryptocurrency ,
Data Protection ,
Distributed Ledger Technology (DLT) ,
EU ,
EU Single Market ,
European Commission ,
General Data Protection Regulation (GDPR) ,
Initial Coin Offering (ICOs) ,
Regulatory Oversight ,
Smart Contracts ,
Tax Avoidance ,
Tax Evasion
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
A data lake is an infrastructure that permits different data sets from within a group to be combined and analysed together.
To analyse a data lake under GDPR, it is helpful to think of a data lake in two phases, which we...more
8/9/2018
/ Data Collection ,
Data Controller ,
Data Management ,
Data Privacy ,
Data Processors ,
Data Protection ,
Data Security ,
EU ,
EU Data Protection Laws ,
General Data Protection Regulation (GDPR) ,
Personal Data ,
Popular ,
Privacy Policy ,
Risk Mitigation
“Getting to Data Nirvana” is our four-step approach to help you integrate your legal, regulatory and compliance work streams into your organisation’s overall data strategy.
...more
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
Three European regulators have warned investors about the risks associated with dealing with virtual currencies, saying they are unsuitable “for most purposes, including investment and retirement planning”....more
2/14/2018
/ Bitcoin ,
Cryptocurrency ,
Digital Currency ,
EU ,
European Banking Authority (EBA) ,
European Securities and Markets Authority (ESMA) ,
Initial Coin Offering (ICOs) ,
International Regulatory Standards ,
Token Sales ,
Unregistered Securities ,
Virtual Currency