News & Analysis as of

Technology Draft Guidance

A&O Shearman

EDPB publishes draft Guidelines on personal data in blockchain and a report on AI privacy risks & mitigations in large language...

A&O Shearman on

On April 14 2025, the European Data Protection Board (EDPB) announced the outcomes of its plenary session that took place on April 8 2025, during which the EDPB adopted draft Guidelines on processing of personal data through...more

Goodwin

Designating a Platform Technology: FDA’s Long-Awaited Draft Guidance

Goodwin on

In newly released Draft Guidance from the U.S. Food and Drug Administration (FDA) entitled, Platform Technology Designation Program for Drug Development, the FDA addresses its new designation program for platform...more

Sheppard Mullin Richter & Hampton LLP

The March on Pharmaceutical Patents?

December 7, 2023, President Biden announced new actions to promote competition in health care and to lower prescription drug costs. Of particular note is a newly unveiled framework for deciding whether the Government may...more

Vinson & Elkins LLP

Pivotal Year for Deep-sea Mining

Vinson & Elkins LLP on

Sixty years after the discovery of polymetallic nodules and thirty years after the establishment of the International Seabed Authority (“ISA”), deep-sea mining could be licensed as early as July 2023. The ISA is expected to...more

Latham & Watkins LLP

Privacy Enhancing Technologies - A Panacea for Data Protection Compliance?

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The Information Commissioner’s Office published draft guidance on privacy enhancing technologies that can be used to comply with privacy-by-design requirements. On 7 September 2022, the Information Commissioner’s Office...more

White & Case LLP

EDPB issues guidelines on right of access under Art. 15 GDPR

White & Case LLP on

On January 18, 2022, the European Data Protection Board (the "EDPB") issued the Guidelines 01/2022 on data subject rights - Right of access (the "Draft Guidelines"), laying out its interpretation of Article 15 GDPR on the...more

Bass, Berry & Sims PLC

New FDA Draft Guidance on Use of Digital Health Technologies in Clinical Trials

Bass, Berry & Sims PLC on

On December 23, 2021, the United States Food and Drug Administration (FDA) announced the availability of a draft guidance for industry, investigators, and other stakeholders entitled “Digital Health Technologies for Remote...more

ArentFox Schiff

US State Department Seeks Feedback on Amorphous Human Rights Due Diligence for US Exporters of ‘Surveillance’ Items

ArentFox Schiff on

The US State Department is soliciting feedback on its draft “US Government Guidance for the Export of Hardware, Software, and Technology with Surveillance Capabilities and/or Parts/Know-How,” issued September 4, 2019 (Draft...more

Saul Ewing LLP

FDA Releases Draft Guidance To Help Determine Substantial Equivalence for a Device that Has Different Technological...

Saul Ewing LLP on

In a new Draft Guidance entitled, Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics, (the “Draft Guidance”) released on...more

Searcy Denney Scarola Barnhart & Shipley

FDA Issues Draft Guidance on 510(k)

The FDA issued a new draft guidance on July 15th which further explains how the FDA currently fails to protect consumers of medical devices and pharmaceutical drugs. It is important to remember that these sort of FDA-issued...more

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