News & Analysis as of

Research and Development Data Protection

Skadden, Arps, Slate, Meagher & Flom LLP

EU and Germany Lay Groundwork for the Use of Medical Data for Research and AI Training

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

Health Care Compliance Association (HCCA)

As AI-Assisted Research Advances, Experts Share Worries, Oversight Strategies; Collaboration Urged

At Cornell University, institutional review board (IRB) members meet with the chief information security officer and a liaison to the general counsel’s office. Their regular attendance has been “really critical,” said IRB...more

Akin Gump Strauss Hauer & Feld LLP

Senate Majority Leader Schumer Continues Push for AI Framework

On Wednesday, June 21, 2023, Senate Majority Leader Chuck Schumer (D-NY) unveiled the five policy objectives underpinning his ongoing work on a legislative framework to regulate Artificial Intelligence (AI)—the Security,...more

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights - V 4, Issue 5, May 2023

Cyber Resilience Programs Falling Short on Preparing Workers for a Crisis- “At two-thirds of organizations, there is a fear that almost all employees, 95%, will not understand how to recover following a cyberattack.” ...more

Bradley Arant Boult Cummings LLP

Accountable AI Systems through Risk Management:  NIST Creates Inaugural Framework with Principles and Playbook

On January 26, 2023, the U.S. National Institute of Standards and Technology (NIST) released the Artificial Intelligence (AI) Risk Management Framework (AI Risk Management Framework 1.0), a voluntary guidance document for...more

A&O Shearman

UK – DCMS publishes an updated Digital Strategy

A&O Shearman on

On 13 June 2022, the UK’s Department of Digital, Culture, Media and Sport (DCMS) published its 2022 Digital Strategy (the Strategy)....more

Hogan Lovells

Pharmacovigilance in Spain: Takeaways from the new code of conduct (Part 2)

Hogan Lovells on

Some weeks ago, we described the highlights of the new "Code of Conduct on the processing of personal data in the field of clinical trials and other clinical research as well as pharmacovigilance" (CoC) and the impact on data...more

Hogan Lovells

Clinical trials in Spain: Takeaways from the new code of conduct (Part 1)

Hogan Lovells on

Last week we raised our hands to inform you about the Spanish Data Protection Authority’s approval of the "Code of Conduct on the processing of personal data in the field of clinical trials and other clinical research as well...more

Hogan Lovells

ICO consults on new guidance for conducting scientific research under the UK GDPR

Hogan Lovells on

Research and development, innovation, product and service improvement, AI design and deployment...these are key commercial drivers for the successful modern business. They also underpin technological, medicinal, and other...more

Alston & Bird

Major Overhaul of EU Clinical Trial Rules Kicks In on 31 January 2022

Alston & Bird on

On 31 January 2022, the EU Clinical Trial Regulation (CTR) will come into application, almost 8 years after its adoption by the European Parliament and the Council of the EU. The CTR will radically change the regulatory...more

Pillsbury Winthrop Shaw Pittman LLP

Trump vs. Biden: Technology and the Internet

In this election cycle, technology and internet policy is a persistent factor across multiple issue areas. With implications for national security, economic equality, infrastructure and market regulation, the next...more

Oberheiden P.C.

Theft of U.S. Companies’ IP Assets and Other National Security Issues Involving Foreign Governments and Foreign-Controlled...

Oberheiden P.C. on

Federal authorities have recently described the threat of economic espionage from foreign entities as one of the greatest threats to the economic vitality of the United States, and this has led to an increase in...more

Troutman Pepper

New Cyber Threat Warnings And Guidance Issued For Health Care Entities Conducting COVID-19 Research

Troutman Pepper on

On May 21, the Federal Bureau of Investigation’s (FBI’s) Cyber Division released an FBI Flash warning recipients that nation-state cyber actors are targeting domestic universities, research institutes and private companies...more

Morgan Lewis

Germany Approves New Forms for Patient Consents

Morgan Lewis on

New patient consent forms in Germany cover the use of patient care data and clinical and biomedical research. German Data Protection Commission DSK has approved a revised version of forms that the so-called Medical...more

Pillsbury Winthrop Shaw Pittman LLP

Changes to Small Business Innovation Research Data Rights

Small businesses should prepare for new data rights provisions appearing in Small Business Innovation Research (SBIR) contracts. The Department of Defense (DoD) class deviation addressing SBIR contracts will cause...more

Akin Gump Strauss Hauer & Feld LLP

U.S. Chamber’s AI Principles Latest Industry Effort to Push Policy

As Congress and the Administration continue to advance federal initiatives related to artificial intelligence (AI), private stakeholders also continue to make their voices heard. On September 23, 2019, the U.S. Chamber of...more

Akin Gump Strauss Hauer & Feld LLP

Policymakers Focusing in on Artificial Intelligence

Following a series of recent events involving policymakers from Trump’s Administration and Capitol Hill, artificial intelligence (AI) was the second hottest topic in D.C. These events, described in detail below, demonstrated...more

Smart & Biggar

Certificate of Supplementary Protection Regime: First Anniversary Update

Smart & Biggar on

September 21, 2018 marked the first anniversary of the certificate of supplementary protection (CSP) regime. CSPs, which provide an additional patent-like protection term, are intended to partly compensate innovators for the...more

Proskauer - Blockchain and the Law

Colorado Senate Bill Proposes Utilizing Blockchain Technology to Improve State Government’s Operations and Cybersecurity

The Colorado Senate is considering a bill to utilize blockchain or other distributed ledger technology for a variety of purposes, including to improve the state government’s operations and cybersecurity. Senate Bill 18-086...more

Searcy Denney Scarola Barnhart & Shipley

Hacking Gains New Heights with Threat to Big Pharma

Cyber attacks have broken free from their initial molds of carting off with consumer credit card numbers or stealing someone’s identity. The act of digitally digging into cyberspace has hit the U.S. Department of Health &...more

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