On October 18, 2018, FDA issued a long-awaited draft revision to its existing guidance “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices”(premarket cybersecurity guidance). This coincided with release of the FDA-supported incident preparedness and response playbook, the announcement of two new Information Sharing Analysis Organizations (ISAOs), and FDA’s recent news release discussing the agency’s enhanced cybersecurity partnership with the U.S. Department of Homeland Security (DHS) earlier this month. FDA’s recent flurry of activity focuses on providing additional clarity about when to interact with FDA, what information would be useful in submissions, and what level of documentation is expected. Cybersecurity clearly is a high priority issue for FDA and the agency is working hard to bring together stakeholders and provide the best information it can so that all entities that are involved in managing the multifaceted and evolving area of cybersecurity have the best and most current information to manage the risks of a cybersecurity intrusion.
Data protection authorities set out guidelines for the application of the new EU General Data Protection Regulation. The European Data Protection Board is the joint coordination body of the EU data protection authorities. The EDPB provides guidance on the application of the EU Data Protection Regulation. With the GDPR having come into force, the EDPB thus replaces the Art. 29 Data Protection Working Party which was established under the EU Data Protection Directive and other previously applicable data protection laws.
Hot on the heels of the European Commission’s official review of the functioning of the EU-U.S. Privacy Shield framework, the Article 29 Working Party of EU data protection regulators has issued its own report on the matter. The summary of findings by the Working Party, which draws from both written submissions and oral contributions, begins by commending U.S. authorities for their efforts in establishing a procedural framework to support the operation of Privacy Shield but quickly shifts to the Working Party’s concerns. Should the concerns not be addressed by the time of the second joint review, the Working Party notes that its members will “take appropriate action,” including bringing a Privacy Shield adequacy decision to national courts for reference to the Court of Justice of the European Union for a preliminary ruling.
No one could accuse the EU Article 29 Working Party of not delivering as promised. Following its recently held December plenary meeting, the WP29 has released three separate guidelines with their interpretation of some key aspects of the General Data Protection Regulation, namely: data portability, data protection officers, and lead supervisory authorities. At the same time, the WP29 has confirmed its role as the “EU centralised body” for handling individual complaints under the Privacy Shield and the re-establishment of its enforcement subgroup in charge of coordinating cross-border enforcement actions. We explore the three guidelines in this post.
If you’ve ever opened your washing machine to find white socks turned a pale shade of pink, you can relate to the sentiment of Buzzfeed UK’s piece “14 Laundry Fails We’ve All Experienced.” Humorous and empathetic, the piece mimicked Buzzfeed’s editorial tone and style, but also subtly promoted the message of a commercial advertiser—in this case, Dylon, a color dye manufacturer. And in what may be a sign of things to come in the US, the piece drew the attention of the U.K.’s advertising regulator, the Advertising Standards Authority, which cited Buzzfeed for failing to make the piece “obviously identifiable” as commercial content, a violation of the U.K.’s Committee on Advertising Practices Code.
Drawing on the increasing use of wireless, Internet- and network-connected medical devices, the Food and Drug Administration issued a draft guidance document for comment on June 14, 2013, proposing that manufacturers of medical devices that contain software, firmware, or programmable logic, address cybersecurity risks in premarket submissions. The draft guidance represents the Agency’s most direct and recent effort to address the potential risks of compromised medical device functionality due to intentional or unintentional cyber-attacks. In conjunction with the draft guidance, FDA issued a safety communication on its website addressing not only medical device manufacturers, but hospitals, medical device user facilities, and health care IT and procurement staff, recommending that these facilities also take steps to ensure that safeguards are place to reduce the risks of medical device failures resulting from cybersecurity breaches, and report such failures.
On November 26, the U.S. Department of Health and Human Services’ Office for Civil Rights released guidance on methods for de-identification of protected health information in keeping with the HIPAA Privacy Rule (as required under the HITECH Act). The guidance answers questions related to each of the permissible de-identification methods – the expert determination […]
The Hong Kong Privacy Commissioner for Personal Data recently issued a guidance note entitled “Guidance on Collection of Fingerprint Data” to provide guidance to data users on how to comply with the Personal Data (Privacy) Ordinance when collecting fingerprint data. The Guidance Note elaborates on a guidance note published by the Commissioner in 2007 in light of the Commissioner’s views adopted in relation to numerous enquiries and investigations relating to the collection of fingerprint data since the 2007 Guidance Note was issued.
Following up on a public workshop held earlier this year, today the Federal Trade Commission (FTC) issued a set of truth-in-advertising and privacy guidelines for mobile device application (app) developers. Titled “Marketing Your Mobile App: Get it Right From the Start,” the guidelines provide an overview of key issues for all app developers to consider.
Organisations in Hong Kong are required under the Personal Data (Privacy) Ordinance to erase personal data when the data is no longer required for the purpose for which it was collected.
The Hong Kong Privacy Commissioner for Personal Data recently has published a Guidance Note, entitled “Guidance on Personal Data Erasure and Anonymisation,” which is relevant to compliance under the Ordinance.
On October 31st, Hogan Lovells will present a complimentary webinar exploring the impact of the SEC cybersecurity risk Disclosure Guidance, featuring senior lawyers in the Hogan Lovells Capital Markets and Privacy and Information Management practices, as well as a managing director of Stroz Friedberg LLC, a technology firm assisting clients with digital risks. This blog entry invites readers to register for the webinar.
A financial services industry group recently released guidance on managing the risks associated with using social media such as Facebook and Twitter. The guidance, titled “Social Media Risks and Mitigation,” was released this week by BITS, a division of the Financial Services Roundtable, which represents 100 of the largest financial services companies. The guidance includes tips on managing numerous concerns specific to financial institutions, which are increasingly using social media in their marketing and customer relationship activities.
The UK’s data protection authority, the ICO, has issued a code of practice for online privacy. Although only advisory in nature, the code contains excellent information on what are viewed as “best practices” in the protection of personal privacy online. It should be of particular interest to businesses engaged in behavioural advertising, online sales and cloud computing. This blog entry summarizes and links to the code.