Medical Device Legal News with Sam Bernstein: Episode 11
On February 13, 2024, the US Food and Drug Administration (FDA) issued draft guidance entitled Use of Data Monitoring Committees in Clinical Trials (Draft Guidance). It provides sponsors and others involved in clinical trial...more
The Israeli Privacy Protection Authority recently published a draft directive regarding boards of directors’ role in fulfilling obligations pursuant to the Privacy Protection (Data Security) Regulations. The directive states...more
On 18 August 2023, the UK’s Information Commissioner’s Office (“ICO”) published draft guidance on biometric recognition (the “Draft Guidance”) for public consultation. The Draft Guidance explains how data protection law...more
The California Privacy Protection Agency (CPPA) recently published two new sets of draft regulations addressing a range of cutting-edge data protection issues. Although the CPPA has not officially started the formal...more
The California Privacy Protection Agency (CPPA) recently published two new sets of draft regulations addressing a range of cutting-edge data protection issues. Although the Agency has not officially started the formal...more
FTC Settles with Experian for Alleged Customer Spamming - On August 14, 2023, the Federal Trade Commission (“FTC”) announced a proposed settlement involving Experian Consumer Services (“Experian”). A federal court entered...more
Following the introduction of the Age-Appropriate Design Code (the Code) on 2 September 2021, companies have questioned whether the Code applies to their online service. A recent consultation by the ICO seeks to clarify when...more
The updated guidelines (05/2021) from the European Data Protection Board (“EDPB”) issued on 14 February 2023 (the “New Guidelines”) look at the interplay of two fundamental, protective mechanisms contained in the EU GDPR....more
US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more
It has been a bustling fall for the California Privacy Protection Agency (CPPA or Agency). In the spirit of the upcoming holiday season, the Agency gifted us not one but two rounds of proposed modifications to the regulations...more
The California Privacy Protection Agency (CPPA) recently released the draft proposed CCPA Regulations and draft initial statement of reasons. Importantly, these are draft regulations that are likely to be subject to extensive...more
The EDPB sets out relevant steps and factors that EU supervisory authorities should consider when calculating administrative fines under the GDPR. On 16 May 2022, the European Data Protection Board (EDPB) adopted draft...more
The U.S. Food and Drug Administration (FDA) issued updated draft guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” which aims to help industry take a more...more
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
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
On January 28, 2022, the European Data Protection Board (“EDPB”) published draft regulatory guidelines (“draft guidance”) on the right of data subjects to have access to their personal data under the EU General Data...more
On November 19 the European Data Protection Board (EDPB) published draft guidelines on the interplay between Article 3 of the GDPR (which establishes the GDPR’s territorial scope), and the GDPR’s international transfer...more
In 2016, European companies doing business in the US were able to breathe a sigh of relief. The European Commission deemed the Privacy Shield to be an adequate privacy protection. For the next half a decade, this shield, as...more
In this month's edition, we examine the European Commission's Digital Services Act and its potential regulatory impact, the National Institute of Standards and Technology's draft guidance on internet-of-things devices'...more
US companies and other organizations whose activities involve the use of personal information from Europe were unsettled by the EU Court of Justice’s July 2020 Schrems II decision that cast doubt on the lawfulness of...more
NIST recently released the final public draft of SP 800-172, Enhanced Security Requirements for Protecting Controlled Unclassified Information: A Supplement to NIST Special Publication 800-171 (formerly Draft NIST SP...more
On February 7, 2020, the European Data Protection Board (EDPB) published draft guidelines on the processing of personal data in the context of connected vehicles and mobility related applications. If adopted in their current...more
On February 19, 2020, the Information Commissioner’s Office (ICO), the data protection regulator in the United Kingdom, launched a consultation on its draft guidance on the artificial intelligence (AI) auditing framework. ...more
The European Data Protection Board has published draft guidelines for public comment on the data protection aspects of connected vehicles. Key takeaways: The Relevant Players- Non exhaustive list of stakeholders: vehicle...more
In 2019, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below: 1) PMPRB: Amendments to Regulations will come into force July 1, 2020, court...more