National Telehealth Takedown Highlights Opportunity for Providers to Enhance Compliance Efforts

The US Department of Justice and the US Department of Health and Human Services Office of Inspector General recently announced a significant healthcare fraud takedown involving $4.5 billion in allegedly false and fraudulent claims involving telehealth. The allegations involved telehealth executives paying healthcare providers to order unnecessary items and services, as well as payments from durable medical equipment companies, laboratories and pharmacies for those orders. While the alleged conduct is not representative of the legitimate and crucial telehealth services offered by the vast majority of healthcare providers, the government’s continued focus on telehealth arrangements, combined with the ongoing expansion of coverage for telehealth services, provides an important opportunity for healthcare providers to evaluate their telehealth service offerings and arrangements and to further enhance their related compliance activities. In Depth On September 30,...

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CCPA Amendment Update: California Governor Approves CCPA Amendment with Exceptions for HIPAA De-Identified Information and Other Health Data

On September 25, 2020, Governor Gavin Newsom signed into law California AB 713, which amends the California Consumer Privacy Act (CCPA) to create expanded exceptions for: HIPAA business associates; information that has been de-identified in accordance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA); and information collected, used or disclosed in certain human subjects research. AB 713 reflects an intense lobbying effort by medical technology, pharmaceutical, and other health and life sciences industry stakeholders. AB 713 became effective immediately following Governor Newsom’s signature, as the bill included an urgency clause calling for immediate action to mitigate the CCPA’s potential negative impact on health-related research. AB 713 eases some of the CCPA compliance challenges experienced by the health care and life sciences industries by more closely aligning the CCPA with HIPAA and other laws governing human subjects...

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Double Trouble for Data Transfers Post-Brexit and Post-Schrems II?

On 16 July 2020, Europe’s highest court, the CJEU, ruled in Data Protection Commissioner v. Facebook Ireland Limited, Maximillian Schrems that individuals in Europe had insufficient redress against US bulk interception rules when their personal data was transferred to the United States under the US Department of Commerce “Privacy Shield” mechanism. This ruling followed a long running campaign by the activist, Max Schrems, who’s prior case to the CJEU invalidated the predecessor to the Privacy Shield, the Safe Harbor. It is a general tenet of European data protection law that, when personal data is exported from the European Union, any further processing must be to European standards unless the local data protection laws are considered “adequate” by the European Commission. Self-certification under the US Privacy Shield mechanism was a popular method for providing adequate data protection amongst US based service providers which had European customers and...

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After the Curve Podcast: Focus on Digital Health

COVID-19 has demanded a rapid shift in the world of telehealth and digital health, resulting in a global embracing of a telehealth and digital health system that is not yet fully developed. On this episode of the McDermott Health podcast, our digital health partners have joined to discuss the future of telehealth and use of digital tools to speed up care delivery and to improve outcomes in the wake of COVID-19, as well as the vital role of data readiness in reshaping the healthcare system. McDermott’s Chief Marketing Officer Leslie Tullio is joined by partners Stephen Bernstein and Lisa Mazur to examine current trends and potential changes to both telehealth as well as the broader digital health landscape, including: The most impactful regulatory telehealth changes that have resulted from COVID-19 A look beyond telehealth to a paradigm shift in the broader digital health landscape The impact that a more refined data exchange pathway could have on treatment...

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Data Protection During and After the Pandemic: Consolidate, Update and Innovate

Having adapted products, processes, services, facilities and IT systems in response to Coronavirus (COVID-19), businesses should now refocus on their legal and business fundamentals as they move towards returning to the office. Compliance policies should be updated, Brexit contingency plans reinvigorated, and upcoming legal and regulatory changes anticipated. While taking these steps, businesses should bear in mind a number of key data protection and IT/cybersecurity fundamentals, and take the opportunities afforded by the return to work period to kick-start new initiatives. Click here to read the full article, and many more in our latest International News: Focus on Global Privacy and Cybersecurity.  

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Brazil’s LGPD Takes Effect—With Early Enforcement

Brazil represents over half of all IT spend in Latin America, has the largest regional market for software outsourcing, employs a sizable IT workforce, manufactures consumer goods (including commercial airplanes and cars) and has an active consumer market of social media operated by global data aggregators. At a time when data privacy is becoming increasingly important to consumers, it seems only fitting that Brazil would adopt comprehensive privacy legislation to protect data privacy rights. The General Data Protection Law, the first law of its kind in Brazil, is now in effect, and we are already seeing enforcement. Streamlining the legal framework on data protection, the law sets forth a number of requirements addressing legal bases for processing, individual rights, governance and accountability and data transfers. Access the article.

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The Uncertain “State” of US Data Protection Law: California Leads the Way

The California Consumer Privacy Act of 2018 (CCPA), which took effect this year, introduced a complicated data protection framework for the personal information of California residents, imposing a variety of new obligations on affected businesses. Although the interpretation of many of the CCPA’s provisions remains unsettled—and proposed regulations are still pending— the CCPA’s original architects have already advanced another proposed law, the California Privacy Rights Act (CPRA), which will be decided in a statewide referendum this November. If enacted, the CPRA would substantially amend the CCPA, granting consumers additional rights and imposing further liability on businesses. Whether or not it passes, the proposed CPRA highlights the fluid state of the US legal environment for data protection, which has left businesses around the world struggling to account for the uncertain risks and compliance costs posed by these developments. It did not have to be...

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Privacy Considerations for COVID-19 Digital Contact Tracing

Generally, contact tracing refers to an effort by public health officials to identify individuals with whom a patient who has tested positive for an infectious disease has been in close proximity. Public health officials will inform these individuals that they were exposed to a contagious patient and encourage them to monitor their symptoms and quarantine for a period of time. In response to COVID-19, governments around the world have explored using digital contact tracing, by which smartphone users download an application (app) to enable public health officials to track infected individuals’ contacts. In addition, private sector companies are exploring how digital technologies can be used for contact tracing on employees as they reenter the workplace. Click here to read the full article, and many more in our latest International News: Focus on Global Privacy and Cybersecurity.

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Uber Criminal Complaint Raises the Stakes for Breach Response

On August 20, 2020, a criminal complaint was filed charging Joseph Sullivan, Uber's former chief security officer, with obstruction of justice and misprision of a felony in connection with an alleged attempted cover-up of a 2016 data breach. These are serious charges for which Mr. Sullivan has the presumption of innocence. At the time of the 2016 data breach, Uber was being investigated by the US Federal Trade Commission (FTC) in connection with a prior data breach that occurred in 2014. According to the complaint, the hackers behind the 2016 breach stole a database containing the personal information of about 57 million Uber users and drivers. The hackers contacted Uber to inform the company of the attack and demanded payment in return for their silence. According to the complaint, Uber's response was to attempt to recast the breach as a legitimate event under Uber's "bug bounty" program and pay a bounty. An affidavit submitted with the complaint portrays a...

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The Toughest Problem Set: Navigating Regulatory and Operational Challenges on University Campuses

When the academic year ended in the spring of 2020, many US university students assumed that a return to campus would be straightforward this fall. However, it is now clear—at least in the near term—that a return to the old “normal” will not be possible. Some universities have concluded that their best course of action is to offer only distanced learning for the time being. Other universities, however, are welcoming students back onto campus, and into residence and dining halls, classrooms, labs and libraries. Each of those universities is developing its own approach to retain the benefits of on-campus student life while reducing risk to the greatest extent possible; nevertheless, some have had to adjust their plans to pivot to remote learning when faced with clusters of positive cases on campus. One thing is clear: The fall semester will be a real-time, national learning laboratory. Because widespread, rapid testing remains unavailable in many locations,...

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