On September 15, 2021, the Federal Trade Commission (FTC) voted 3–2 along party lines (with Republican commissioners dissenting) to issue a policy statement announcing an expansive interpretation of the FTC’s Health Breach Notification Rule, 16 CFR Part 318 (the Rule). According to the policy statement, the Rule applies to health apps and connected devices that are not subject to the Health Insurance Portability and Accountability Act (HIPAA) but are capable of drawing information from multiple sources—for example, through a combination of consumer inputs and application programming interfaces (APIs).
Telemedicine in the United States is facing an important crossroads. While telehealth services have demonstrated their value as an integral part of care delivery, federal and state waivers instituted during the COVID-19 pandemic are likely to expire soon. As lawmakers and agency officials consider updated or expanded digital health rules, regulators are expected to intensify their scrutiny of providers.
Can employers mandate some employees get the vaccine and not others? Is there an obligation to consider requiring a COVID-19 test before coming back to work? What are the potential workers’ compensation claims relating to possible adverse reactions to a vaccine? Should employers mandate vaccinations?
In this video, McDermott Will & Emery partner Amy C. Pimentel explains the significance of health data transfers from the European Union to the United States in a post-Schrems II world. The recent Schrems II ruling invalidated the EU-US Privacy Shield, holding that the US legal regime on access to personal data does not contain adequate limitations and safeguards. Pimentel and McDermott’s Romain Perray recently also wrote for McDermott’s International News about this topic.
On January 7, 2021, the Equal Employment Opportunity Commission (EEOC) issued proposed guidance regarding employer-sponsored wellness programs and the level of incentives employers may offer employees who participate in these programs in the form of two proposed rules. On January 20, 2021, the Biden administration ordered agencies to immediately withdraw most unpublished rules, including the EEOC proposed rules. Agencies may not issue any new regulations until they can be reviewed and approved by agency or department heads appointed or designated by President Biden.
On September 25, 2020, California Governor Gavin Newsom signed into law California AB 713, which amends the California Consumer Privacy Act (CCPA) to except from its requirements certain health information, including information that has been de-identified in accordance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The bill’s enactment 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 research. The new law also amends the CCPA to except all business associates to the extent that they maintain, use or disclose patient information in the same manner as protected health information under HIPAA.
Because widespread, rapid COVID-19 testing remains unavailable in many locations, universities have had to find innovative ways to implement testing, tracing and isolation protocols to reduce the risk of transmission among students, faculty and staff. There is no one perfect protocol—all universities are in unchartered waters. But there are a few key components university administrators may want to consider and address.
Employers are poised to collect health data from their workforces daily as they adopt temperature checks and other screening protocols to fight the coronavirus, triggering concerns about workers’ privacy and whether the practices will continue beyond the pandemic.
“The temperature checks give employees and customers the feeling of safety and the idea that the company is doing everything possible, even if the screenings don’t protect the workplace,” said Michael Sheehan, a partner with McDermott Will & Emery, in a recent Bloomberg Law article.
With rapid developments in local, state and federal guidance and law, the appropriate approach for each employer in relation to COVID-19 will vary depending on the nature of their work, the industries served and their location and size, among other considerations. This article outlines what employers need to know about employees experiencing symptoms and employee absences.
Telehealth is no longer just a nice-to-have, but instead a must-have for patients and healthcare professionals alike during the COVID-19 pandemic. Lisa Mazur, partner at McDermott Will & Emery specializing in the digital healthcare space, is quoted in a recent Forbes article about why telehealth is here to stay: “Telehealth was already experiencing significant momentum and growth prior to this public health emergency, and its continued trajectory has been solidified by the vital role it is playing in care delivery today.”
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