European Commission Provides Important Guidance on Qualification and Classification of Software Under New Medical Devices Regulations

The European Commission’s Medical Devices Coordination Group (MDCG) has published a much-anticipated guidance on the qualification and classification of software devices as medical devices (MDSW)1  under the new Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulations (IVDR) (the Guidance, available here). The Guidance seeks to provide clarification to medical software manufacturers with respect to (i) when software is considered a device (qualification) and (ii) what risk category the device falls into (classification).

Under the currently applicable rules, supported by guidance set out in MEDDEV 2.1/6,2 most software devices are classified as low risk. However, the new classification rules set out in the MDR, in particular Rule 11, significantly change the classification of MDSW, with many software devices to be generally considered medium- or even high-risk devices.

Here we examine which areas have been clarified by the Guidance and which topics remain open to interpretation.

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The Final Countdown: What You Need to Know About the CCPA and its Draft Regulations Before January 1

Companies doing business in California or with Californians must be ready to comply with the California Consumer Privacy Act (CCPA) by January 1, 2020 – less than three months away. However, as businesses were putting the finishing touches on their compliance efforts, the California legislature amended the law and the Attorney General proposed a round of very significant regulatory requirements. Now businesses find themselves making last-minute adjustments as the deadline approaches.

Please join us for a discussion that highlights the key takeaways from the recent CCPA amendments and proposed regulations, identifies the steps companies should be taking to meet these new obligations, and provides benchmarks for how companies are addressing key issues surrounding the CCPA.

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Observations from Albania: the 41st Annual International Conference of Data Protection and Privacy Commissioners (October 23-24, 2019)

UK ICO Commissioner Liz Denham, who serves as Conference Chair, welcomed attendees at the public session and provided a brief summary of what transpired at the Commissioners’ closed door sessions. She noted that “privacy” has gone “mainstream.” People around the world expect more information about how their data is used. She stressed the importance of future international collaboration and regulatory cooperation to develop shared strategies and tactics “to protect people from big companies.”

Commissioner Denham also highlighted the increased focus on the role of data protection as a relevant consideration in competition analysis by international regulators. She noted that the International Privacy Commissioners’ Conference, and the ongoing assembly of global regulators, resolved to be more transparent in the future with respect to the regulated community and other interested parties. Finally, she hinted that a new name for the group would be announced before the 2019 conference concludes.

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Blockchain 2019: Smart Contracts

Please join us for the fourth in a series of programs focused on 2019 blockchain developments. This webinar will discuss legal, regulatory and other considerations for smart contracts. Lawyers from Sidley’s blockchain, investment funds and global finance practices will discuss:

  • The blockchain technology behind smart contracts
  • The legal validity of smart contracts under state law
  • Court decisions and industry initiatives addressing obligations embedded in smart contracts
  • Practical considerations for smart contract implementation in transactions

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Women in Privacy

Women in Privacy™ or WIP™ invites you to join our networking event featuring a roundtable discussion of the latest data protection and privacy hot topics followed by a drinks reception.

The Women in Privacy networking group is for data protection and privacy professionals and aims to provide a platform for high-level discussion of data protection and privacy law developments, to facilitate and strengthen networking among women privacy professionals, and to mentor and promote the advancement of women in the field.

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CCPA In-Depth Series: Draft Attorney General Regulations on Verification, Children’s Privacy and Non-Discrimination

This post is the third in a three part series taking a deep dive into the five key articles of the Attorney General’s CCPA draft regulations: Article 2 on Notice to Consumers; Article 3 on Business Practices for Handling Consumer Requests; Article 4 on Verification of Requests; Article 5 on Special Rules Regarding Minors; and Article 6 on Non-Discrimination. Today we look at verification, children’s privacy and the non-discrimination provisions. Visit the CCPA Monitor for a collection of all our CCPA insights.

INTRO AND BACKGROUND. In the summer of 2018, the California Legislature drafted and passed the California Consumer Privacy Act (CCPA) in record time. Facing a procedural deadline for a ballot initiative, the Legislature acted with dispatch, as it did not want to add to the State Constitution, with its super-majority amendment requirements, many of the provisions that ultimately found their way into the CCPA. This abbreviated legislative process produced a bill with numerous gaps and anomalies, however. Businesses, consumer advocates, and privacy watchers have thus been eagerly waiting for over a year for the Attorney General to propose the regulations the CCPA requires him to promulgate.

On October 10, 2019, this wait finally ended. As laid out below, the nature and breadth of the Attorney General’s proposed regulations explain why they took so long to produce. Put simply, the proposed regulations are significant and will have substantial implications on businesses’ ongoing efforts to comply with the CCPA with less than three months left to go before the effective date. Indeed, even if they do not resolve all of the Law’s many ambiguities, they do provide helpful implementation guidance – along with surprising new requirements, some of which may questionably extend beyond the CCPA itself.

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CCPA In-Depth Series: Draft Attorney General Regulations on Consumer Requests

This post is the second in a three part series taking a deep dive into the five key articles of the Attorney General’s CCPA draft regulations:  Article 2 on Notice to Consumers; Article 3 on Business Practices for Handling Consumer Requests; Article 4 on Verification of Requests; Article 5 on Special Rules Regarding Minors; and Article 6 on Non-Discrimination.  Today we look at consumer requests.  Check back daily for the next installment, or visit the CCPA Monitor for a collection of all our CCPA insights.

Intro and Background.  In the summer of 2018, the California Legislature drafted and passed the California Consumer Privacy Act (CCPA) in record time.  Facing a procedural deadline for a ballot initiative, the Legislature acted with dispatch, as it did not want to add to the State Constitution, with its super-majority amendment requirements, many of the provisions that ultimately found their way into the CCPA.  This abbreviated legislative process produced a bill with numerous gaps and anomalies, however.  Businesses, consumer advocates, and privacy watchers have thus been eagerly waiting for over a year for the Attorney General to propose the regulations the CCPA requires him to promulgate.

On October 10, 2019, this wait finally ended.  As laid out below, the nature and breadth of the Attorney General’s proposed regulations explain why they took so long to produce.  Put simply, the proposed regulations are significant and will have substantial implications on businesses’ ongoing efforts to comply with the CCPA with less than three months left to go before the effective date.  Indeed, even if they do not resolve all of the Law’s many ambiguities, they do provide helpful implementation guidance – along with surprising new requirements, some of which may questionably extend beyond the CCPA itself.

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