Anna Rudawski (US)

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US Supreme Court expands digital privacy rights in Carpenter v. United States

By Jeewon Kim Serrato (US), Anna Rudawski (US) and Alexis Wilpon (US) on June 27, 2018 Posted in Dispute resolution and litigation

On June 22, 2018, the US Supreme Court issued a 5-4 decision in Carpenter v. United States, holding that the federal government needs a warrant to access cellphone location records. In the decision, the Court agreed that there should be a higher standard for accessing location records due to their intrusive nature.… Continue reading

Working party publishes draft of GDPR guidelines for Article 49 (export derogations)

By David Kessler (US) and Anna Rudawski (US) on March 5, 2018 Posted in Compliance and risk management

On February 12, 2018, the Article 29 Working Party (WP29) published guidance regarding Article 49 of the General Data Protection Regulation (GDPR) for public comment. The deadline for submitting comments on the draft is March 26, 2018, and responses should be emailed to JUST-ARTICLE29WP-SEC@ec.europa.eu. Like the current EU Data Protection Directive, the GDPR prohibits the … Continue reading

WP29 brings Binding Corporate Rules in line with the GDPR

By Lara White (UK) and Anna Rudawski (US) on February 28, 2018 Posted in Regulatory response

On February 6, 2018, the Article 29 Working Party (WP29) adopted updated guidelines on Binding Corporate Rules (“BCRs“), which replace the previous WP29 working documents 153 and 195 on BCRs and Processor BCRs.… Continue reading

“But the emails” – companies’ SEC filings reflect ransomware risks

By Anna Rudawski (US) on September 11, 2017 Posted in Compliance and risk management, Data breach

The Equifax breach will likely devour the entire breach news cycle in the near term, given the size of the incident and that it gets to the essence of the company’s business of maintaining some of the most sensitive consumer information. Still, in what for the moment might seem like a more pedestrian risk, companies … Continue reading

US Senators introduce IoT cybersecurity bill

By Anna Rudawski (US) on August 3, 2017 Posted in Compliance and risk management, Regulatory response, Vendor management and transactions

On August 1, 2017, US Senators unveiled a bipartisan bill to mandate baseline cybersecurity requirements for internet connected devices purchased by the federal government. Recent attacks demonstrate that connected devices, which make up the Internet of Things (“IoT”), can paralyze websites, networks, and even components of critical infrastructure. The draft bill, introduced by a bipartisan … Continue reading

US Coast Guard Releases Draft Cybersecurity Guidelines

By Anna Rudawski (US) on July 26, 2017 Posted in Compliance and risk management, Regulatory response

On July 11, 2017, the US Coast Guard (USCG) and the Department of Homeland Security (DHS) proposed new cybersecurity draft guidelines for Maritime Transportation Security Act (MTSA) regulated facilities. The guidelines follow the White House’s May 2017 Executive Order to strengthen the cybersecurity of critical infrastructure. The draft guidelines are open for public comment until … Continue reading

US Government Contractors Now Required to Train Employees on Privacy

By Anna Rudawski (US) on February 23, 2017 Posted in Compliance and risk management, Regulatory response

Effective January 19, 2017, an update to the Federal Acquisition Regulation (FAR) will require certain contractors that provide services to the federal government to train their employees on privacy. New contracts into which the federal government enters with contractors will include privacy training requirements. In addition, the rule requires contractors to flow down privacy training … Continue reading

FDA issues final guidance on postmarket medical device cybersecurity

By Anna Rudawski (US) on January 5, 2017 Posted in Compliance and risk management, Regulatory response

On December 28, 2016, the U.S. Food and Drug Administration (FDA) released final guidance on the management of cybersecurity vulnerabilities for marketed and distributed medical devices. The guidance establishes a risk-based approach for the reporting of medical device cybersecurity vulnerabilities to the FDA.… Continue reading

US Commission on Enhancing National Cybersecurity: Action Plan for the President-Elect

By Anna Rudawski (US) on December 14, 2016 Posted in Compliance and risk management, Regulatory response

The US Commission on Enhancing National Cybersecurity, a nonpartisan group established by President Obama in early 2016, released its final report on December 1, 2016. The report provides an in-depth view of cybersecurity challenges facing the digital economy, and provides a roadmap for addressing those challenges. For some issues, the Commission recommends that the next … Continue reading

EMA Issues Guidance on Anonymization in Clinical Trials

By Anna Rudawski (US) on November 14, 2016 Posted in Compliance and risk management, Regulatory response

The European Medicines Agency (EMA) issued guidance on the implementation of its Policy 0070 on the publication of clinical data for medicines, including with respect to anonymization of clinical reports for publication. (As background, please see our previous briefing on the EMA’s new approach to transparency of clinical studies here.) As of October 2016, all … Continue reading

HHS Update: Looking Toward Audits and Increased Enforcement

By Anna Rudawski (US) and Mark Faccenda (US) on September 8, 2016 Posted in Compliance and risk management, Regulatory response, Vendor management and transactions

The Department of Health and Human Services and its Office of Civil Rights (OCR) are capping off a very active 2016. In the last 6 months, the OCR has released a new audit protocol, announced new rounds of HIPAA audits, and stepped up enforcement. The flurry of activity comes after a prolonged period of anticipation in … Continue reading

Your Money or Your PHI: New Guidance on Ransomware

By Mark Faccenda (US) and Anna Rudawski (US) on July 14, 2016 Posted in Compliance and risk management, Data breach, Regulatory response

On June 12, 2016, the HHS Office of Civil Rights (OCR) released guidance, entitled “FACT SHEET: Ransomware and HIPAA,” in response to the rising number of ransomware attacks perpetrated against healthcare entities. The guidance addresses Health Insurance Portability and Accountability Act (HIPAA) issues that may arise when medical records containing Protected Health Information (PHI) are compromised … Continue reading