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.
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
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.
Sidley was honored as the Data – Security “Firm of the Year” at the 2019 Who’s Who Legal Awards. Click here for more information on our Privacy and Cybersecurity practice.
Sidley has consolidated its materials and resources on the CCPA, including an amendment tracker, on the new Sidley CCPA Monitor.
Explore the law and Sidley insights, available now.
William Long, partner and global co-leader of Sidley’s Privacy and Cybersecurity practice, has been working on global data privacy and information security matters for a number of years. In particular, William advises international clients on a wide variety of General Data Protection Regulation (Regulation (EU) 2016/679) (‘GDPR’), data protection, cybersecurity and financial services issues.
DataGuidance by OneTrust spoke with William about data protection issues in the financial services sector, and in particular about approaching compliance with the GDPR, sector-specific challenges, issues around Big Data, and cybersecurity.
Terms and conditions generally specify the rules governing the use of a website or mobile application. Since every website is different, custom-drafted terms and conditions are necessary to protect a particular business. Well-crafted terms and conditions might address issues such as payment, taxes, refunds, gift certificates, accounts, disclaimers, user behavior on your site, warranties and limitations on liability.
We held our 5th Annual Privacy and Cybersecurity Roundtable on May 1, in Washington, D.C. The event featured the Chair of the European Data Protection Board Andrea Jelinek and FTC Commissioner Noah Phillips. Other government speakers represented the White House, UK’s Information Commissioner’s Office, and staff members from the U.S. Senate and House of Representatives. Other distinguished panelists included Cam Kerry of Brookings and Jane Horvath from Apple. The speakers addressed privacy and cybersecurity enforcement in the U.S. and EU, Brexit, Online Harms and the prospects for federal privacy legislation. The insightful program was followed by a competition between the sausage-making (and brewing) achievements of leading privacy jurisdictions such as Brussels, California, Washington, D.C. and China (representing a privacy continuum!). Sidley also commemorated “20 Years of CyberLaw at Sidley” – two decades since the founding of today’s Privacy and Cybersecurity practice. We look forward to continuing to thrive and serve our clients. We hope to see you at next year’s Privacy and Cybersecurity Roundtable.
The updated 2019 Chambers Global Practice Guide for Data Protection & Cybersecurity is available, covering important developments across the globe and bringing expert legal commentary for businesses particularly involved in the life sciences sector.
On January 25, 2019, the European Commission published a statement to mark Data Protection Day (January 28, 2019) which, this year, comes eight months after the entry into force of the General Data Protection Regulation (“GDPR”) on May 25, 2018.
The statement indicates that the European Commission considers the GDPR to have had a positive effect, in particular because European citizens are now more conscious of the importance of data protection and of their rights. The European Commission also notes that the Data Protection Authorities (“DPAs”) are enforcing the new rules and better coordinating their actions in the European Data Protection Board. (more…)