Background

In light of the growing concern over cybersecurity and the increasing complexity of medical device supply chains, the Medical Device Coordination Group has released updated guidance on cybersecurity for medical devices (the Guidance). The Guidance is intended to supplement the essential requirements listed in Annex I of the Medical Devices Regulations (Regulations 745/2017 and

Vermont’s Security Breach Notice Act is noteworthy because it has the United States’ shortest deadline for providing preliminary notice of a “security breach” to the state’s attorney general. The deadline is 14 days from discovery of a security breach. Security incident response teams commonly consider the Vermont law early in the response process to determine whether an organization will be required to provide breach notifications to affected Vermont residents and the state attorney general. On July 1, 2020, the Vermont law will be expanded to cover more types of incidents, which may cause organizations to pay even more attention to the Vermont notice deadline. The amendments also provide instructions on how organizations should provide notice in the event that online account credentials are breached.
Continue Reading Amendments to Vermont’s Security Breach Notice Act to become effective July 1

On March 17, 2020, the federal government relaxed a number of telehealth-related regulatory requirements due to COVID-19. On April 3, 2020, California Governor Gavin Newsom issued Executive Order N-43-20 (the Order), which relaxes various telehealth reporting requirements, penalties, and enforcements otherwise imposed under state laws, including those associated with unauthorized access and disclosure of personal information through telehealth mediums.

As stated in the Order, which became effective immediately, telehealth services may help reduce the spread of COVID-19, and strict compliance with certain state telehealth requirements would otherwise “prevent, hinder, or delay appropriate actions to prevent and mitigate the effects of the COVID-19 pandemic.” The Order impacts certain health care facilities, health care providers, health care administrators, clinics, home health agencies, and  hospice providers, generally in instances where non-compliance occurs during the “good faith provision of telehealth services.”

Continue Reading California relaxes key telehealth regulatory requirements during COVID-19 emergency

As the U.S. economy and educational system adapt to work and life at home, it is important to remember that cybersecurity (and related privacy) risks remain and are evolving. Remembering to think through measures that are in place to protect personal information, proprietary information, confidential information, and information needed for ongoing operations can help businesses avoid and mitigate these risks. Appropriate protective measures are specific to changing circumstances, but fortunately, guidance and helpful resources have quickly emerged. We have set forth below some important considerations in assessing administrative, technical, and contractual cybersecurity safeguards in virtual business and educational settings.

New tools bring new vulnerabilities

Many entities whose employees are now working from home for the first time are implementing new, sometimes expensive, tools to help their employees collaborate and maintain business operations. These new tools include videoconferencing, file-sharing, and other communication platforms. Even if the employer does not provide the tools, employees may find and use their own.

There are good reasons for implementing these tools at the business level, including consistent-use practices in the entity’s system, a process for regular software patches and updates, and discounted pricing. When selecting and implementing these tools, or modifying the manner and extent by which these tools will be used, it can be easy to overlook or minimize better practices for use of third-party information technology services: reasonable and appropriate diligence, contractual protections, and ongoing oversight and validation.

In addition, it is important to remember that the cybersecurity posture of many (if not most) online tools can vary widely depending on how the tool is configured, maintained, and used. This means considering whether the right virtual-IT skill set has been engaged and applied, and helping ensure that users have the information they need to make better privacy and data security decisions. Addressing these issues effectively can be especially challenging as work and learning environments change radically.

Continue Reading U.S. cybersecurity – points to remember when business is not as usual

On January 6, 2020, the Director of the Federal Trade Commission’s (FTC’s) Bureau of Consumer Protection, Andrew Smith, published a blog post highlighting recent changes to the Commission’s enforcement orders relating to data security. Industry leaders, law practitioners, Congress, and even the courts have been critical of aspects of the Commission’s data security orders.  In the post, titled New and improved FTC data security orders: Better guidance for companies, better protection for consumers, Smith acknowledges that, upon arriving at the FTC, strengthening the FTC’s orders in data security matters was among Chairman Joseph J. Simons and his first priorities.  Smith’s blog post is a useful roadmap to help understand the practices the Commission requires of companies under its orders.  Lawyers often look to these orders to distill advice for clients in a challenging area where the public shaming of companies after data security incidents is rampant.

The FTC began working towards specific improved data security orders in 2019, and Smith cites seven different 2019 data security orders in an effort to lay out some of these improvements.  The improvements, he notes, resulted in part from a December 2018 FTC hearing addressing areas of improvement for data security orders, as well as a 2018 Eleventh Circuit Court of Appeals decision.

As a result, Smith highlights three major changes that “improve data security practices and provide greater deterrence” for companies and enhance enforceability.  These changes fall into the following three categories:

(1) The orders are more specific.

(2) The orders increase third-party assessor accountability.

(3) The orders elevate data security considerations to the C-Suite and Board level via executive certifications modeled after similar certifications in securities and other laws.

Continue Reading New key features of FTC data security orders highlighted by Consumer Protection Bureau Director

With the California Consumer Privacy Act (CCPA) coming into effect on January 1 and the announcement on 14 January from Google that it will be phasing out third party cookies within the next two years, it seems that 2020 will be a significant year for the adtech industry as industry players react with solutions and

According to a report issued last week, tens of thousands of cannabis dispensary customers’ personal data has been exposed following a data breach of a sales system that at least three (and likely more) cannabis dispensaries may have used to manage their sales to customers. Our recent client alert highlights the increasing threat that cyber