Digital Health Transformation: A Practical Guide for Life Sciences Companies
In 2022, many if not most pharmaceutical, medical device, and other life sciences companies established strategies to innovate digital health technology complementary to their existing strategic focus. The digital transformation of the life sciences industry is still widely unfolding across the marketplace. In 2023 and beyond, the race is on to launch the next generation of digital health technologies to innovate the delivery of therapies to patients.
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EU Publishes New NIS2 Cyber Directive Imposing Liability and Obligations on Senior Management
On 17 January 2023, the new Network and Information Systems Security Directive (“NIS2 Directive”), which is aimed at establishing a minimum level of cybersecurity standards across the EU and is set to replace its predecessor (the NIS or “NIS1 Directive”), entered into force. The new NIS2 Directive aims to further harmonize and strengthen cybersecurity and resilience throughout the EU in response to a continued increase in digitization and rise in cyber (and in particular ransomware) threats – which is estimated to have reached a total cost of €5.5 trillion at the end of 2020 (double the figure of 2015) and continues to rise in the EU and globally notably due to ongoing geopolitical conflicts in Ukraine and Russia. (more…)
Preparing Your 2022 Form 10-K: A Summary of Recent Key Disclosure Developments, Priorities, and Trends
This Sidley Update highlights certain key disclosure considerations for preparing your annual report on Form 10-K for fiscal year 2022, including recent amendments to U.S. Securities and Exchange Commission (SEC) disclosure rules and other developments that impact 2022 Form 10-K filings, as well as certain significant disclosure trends and current areas of SEC focus for disclosures. As always, we invite you to contact us with any questions on these topics or any other SEC reporting and compliance matters.
Broker-Dealers and Investment Advisers Should Double-Check Their “Identity Theft” Programs: SEC Division of Examinations Issues Risk Alert on SEC’s Identity Theft Red Flags Rule, Regulation S-ID
On December 5, 2022, the Division of Examinations of the Securities and Exchange Commission (SEC) released a Risk Alert discussing its observations on Regulation S-ID (Reg. S-ID) from recent examinations of SEC-registered investment advisers and broker-dealers. Reg. S-ID, the SEC’s implementation of the identity theft red flags rule, requires SEC-regulated financial institutions and creditors to develop and implement an identity theft prevention program (Program) with written policies and procedures that are updated periodically. The requirements for the Program are outlined in the text of Reg. S-ID, and there are guidelines in Appendix A to assist firms in creating and maintaining a compliant Program. As Reg. S-ID applies to both SEC and Commodity Futures Trading Commission-regulated entities, financial institutions and creditors should consider their compliance programs accordingly.
Drizly FTC Order Introduces Significant Minimization, Deletion and Retention Requirements
On October 24, 2022, the Federal Trade Commission (“FTC”) issued an order (the “Order”) against the online alcohol marketplace, Drizly, and its CEO, James Cory Rellas, alleging security failures that resulted in a data breach exposing the personal information of approximately 2.5 million consumers. In reaching this conclusion, the FTC alleges that Drizly failed to implement reasonable safeguards to protect the personal information it collected and stored, such as, two-factor authentication for GitHub, access controls for personal data, sufficient written security policies, and appropriate employee training regarding security.
HHS Office for Civil Rights Releases Webinar on Recognized Security Practices: Provides Guidance on Mitigating Potential Violations of HIPAA
Pursuant to legislation passed in 2021, covered entities and business associates subject to HIPAA and facing potential regulatory enforcement may receive some credit lessening to reduce enforcement penalties if they had implemented Recognized Security Practices (RSPs) within the prior 12 months. However, what may constitute RSPs and how a covered entity or business associate can demonstrate implementation of RSPs to receive such credit had not been clear. Now, the Department of Health and Human Services is seeking to provide clarity. (more…)
Developments to Improve the Cybersecurity of Federal Government Agencies, Critical Infrastructure
Recently, several developments have been proposed or announced to help identify and mitigate cyber risk for United States critical infrastructure operators and software in an effort to further bolster the cybersecurity posture of the federal government. (more…)
U.S. Treasury Department Seeks Public Comment On Potential Federal Cyber Insurance Program
The U.S. Treasury Department is seeking public comment on the need and scope for a potential federal insurance response to catastrophic cyber incidents, akin to the one put in place for terrorism insurance after the attacks of September 11, 2001.
Uber Data Breach Results in Corporate Cooperation and Executive Conviction
On October 5, 2022, a federal jury in the Northern District of California convicted former Uber Chief Security Officer Joseph Sullivan of obstructing a federal proceeding and misprision of a felony for his role in deceiving management and the federal government to cover up a 2016 data breach that exposed personally identifiable information (“PII”) of approximately 57 million users, including approximately 600,000 drivers’ license numbers, of the ride-hailing service. Sullivan, a former federal prosecutor, appears to be the first corporate executive criminally prosecuted—let alone convicted—for his response to a data security incident perpetrated by criminals. Sullivan faces a maximum of five years in prison for the obstruction charge, and a maximum three years in prison for the misprision charge.
U.S. FERC Proposes Revisions to Cybersecurity Incentives for Utilities
On September 22, 2022, the Federal Energy Regulatory Commission (FERC) issued a Notice of Proposed Rulemaking (NOPR) regarding Incentives for Advanced Cybersecurity Investment, requesting comment on proposed revisions to regulations implementing the Federal Power Act (FPA). The revisions would provide incentive-based rate treatments for the transmission of electric energy in interstate commerce and the sale of electric energy at wholesale in interstate commerce by utilities for certain voluntary cybersecurity investments. The NOPR was issued in response to a Congressional mandate set forth in the Infrastructure Investment and Jobs Act of 2021, which directed FERC to establish cybersecurity incentives that would encourage investments by utilities in advanced cybersecurity technology and participation in cybersecurity threat information sharing programs. This NOPR replaces a prior cybersecurity incentives NOPR from December 2020.
