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).
Telehealth’s state-by-state regulatory patchwork means that healthcare providers must navigate a variety of regulations that govern which types of care can be provided by virtual means, and even what modalities can be used in different care settings. McDermott’s recent 50-state survey explores the standard and requirements that physicians and nurse practitioners must follow when prescribing non-controlled substances or ordering tests via a telemedicine encounter. Key issues addressed in the survey include:
- In what states are asynchronous solutions permitted?
- What are state rules governing prescriptions when a physician-patient relationship does not exist prior to the telehealth encounter?
- What are state rules on prescribing via audio-visual encounters or audio-only encounters?
- Under what state regulations can a questionnaire be sufficient to create a physician-patient or advance practice registered nurse-patient relationship?
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.
- Privacy considerations beyond the Health Insurance Portability and Accountability Act of 1996, including Federal Trade Commission requirements;
- How to prepare for the Health Breach Notification Rule;
- The ins and outs of advertising telehealth, including claims, endorsements and social media;
- Strategies for engaging with users in the digital environment; and
- Increased fraud enforcement.
The German federal cabinet recently approved the draft law on the digital modernization of healthcare and nursing care. The draft has been criticized for not taking into account lessons learned from the implementation of the 2019 digital health applications (DiGAs) law.
In this International News article, McDermott Will & Emery partner Dr. Stephan Rau and McDermott alumna Dr. Karolin Hiller provide insight into the planned German regulations on DiGAs and digital care applications (DiPAs).
The challenges of the past year have underscored the importance of life sciences to a dramatic degree. With countries worldwide now distributing vaccines that were developed in record time, COVID-19 has also made plain the value of investing in technological and scientific solutions that can reshape the world and improve health outcomes.
The pandemic has particularly accelerated investments in the digital health space, as a significant share of everyday life has migrated to computer screens by necessity. So what does this mean for the sector going forward?
Writing for MPO Magazine, McDermott partner Steve Bernstein shares five themes to watch in the digital health sector, including what life sciences developers and investors should know about the current deal-making landscape.
The 100% Consolidated Omnibus Budget Reconciliation Act (COBRA) subsidy in the $1.9 trillion American Rescue Plan Act (ARPA) means that more than two million laid off Americans will have the option to extend their workplace healthcare insurance for free—temporarily.
In a recent article for Forbes, McDermott partner Judith Wethall outlines what the COBRA subsidy potentially means for employers.
Imagine if you were playing on a baseball team and the opposing players argue that you are violating the rules of soccer. That’s what it’s like when private parties and the Department of Labor (DOL) challenge Employee Stock Ownership Plan (ESOP) valuations. Plaintiffs play a very different valuation ballgame, which confounds experts who go up against them in a dispute involving allegations that an ESOP paid more than “fair market value” for stock of the sponsor company. In a recent webinar, McDermott attorney Richard Pearl discussed valuation concepts and some fundamental issues under the Employee Retirement Income Security Act.
Lisa Schmitz Mazur discusses what states are doing to make telehealth more available, the changing Medicare reimbursement landscape and compliance considerations for providers implementing telehealth during this time.
The demand for healthcare innovation is driving collaboration between formerly disparate healthcare companies and bringing in new players, such as technology companies and start-ups, into an already complex space. As companies build partnerships and pool resources—particularly healthcare data—data ownership presents numerous challenges that need to be addressed throughout the lifecycle of the collaboration. In this episode of the Of Digital Interest, podcast McDermott partners Jiayan Chen and Jennifer S. Geetter explore:
- Key concerns for companies executing data-driven collaborations
- Consumer expectations surrounding data use, data privacy and their impact on digital health collaborations
- The role of HIPAA and federal and state regulators in regulating data use
- Common questions about secondary use and identifiable and de-identified data
- Commercialization strategies and “green flags” for identifying the right collaboration partner
As the telemedicine regulatory and reimbursement environment becomes more cohesive and providers and patients alike embrace technology, opportunities for telemedicine collaborations are likely to grow. Like any collaboration, finding the right partner is crucial for success, particularly at the highly scrutinized intersection of healthcare and technology. This post explores the factors to address when evaluating service providers and vendors for your next telemedicine collaboration.