President Biden’s July 9, 2021, Executive Order—which seeks to increase competition throughout the American economy—takes aim at prescription drug prices. In this article, published in Law360, McDermott partner Emily Jane Cook says Biden’s focus on drug prices is unsurprising given the “significant public interest and frustration” with drug costs.
The seismic, virtually overnight transformation of healthcare delivery as a result of the pandemic has flung open doors to innovation, as a diverse cross-section of digital health and life sciences stakeholders mobilize crisis resources; adjust operations for enhanced screening, sanitization and social distancing measures; harness telehealth capabilities to deliver healthcare remotely; and identify opportunities for smarter, better healthcare going forward.
Writing for The US-Israel Legal Review, partners from McDermott’s Health practice highlight the challenges and opportunities that digital health and life sciences operators and investors should consider as the industry charts a course through the post-pandemic changed healthcare landscape.
On December 16, 2020, the Equal Employment Opportunity Commission (EEOC) issued its first direct guidance for employers regarding COVID-19 vaccines approved or authorized by the Food and Drug Administration (FDA). Important takeaways from the guidance, as well as FAQs from the EEOC, are discussed in the attached link.
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.
The US Departments of Labor, Health and Human Services, and Treasury issued a second set of answers to frequently asked questions. The tri-agency FAQs (Part 43) clarify important health and welfare provisions under the Families First Coronavirus Response Act (FFCRA), which became law on March 18, 2020, and the Coronavirus Aid, Relief, and Economic Security (CARES) Act, enacted on March 27, 2020. Both laws addressed Coronavirus (COVID-19) testing and prevention coverage, as well as expansion of telehealth service availability.
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.
Digital health companies face a complicated regulatory landscape. While the opportunities for innovation and dynamic partnerships are abundant, so are the potential compliance pitfalls. In 2018 and in 2019, several digital health companies faced intense scrutiny—not only from regulatory agencies, but also in some cases from their own investors. While the regulatory framework for digital technology in healthcare and life sciences will continue to evolve, digital health enterprises can take key steps now to mitigate risk, ensure compliance and position themselves for success. We offer three tips for tackling risk in digital health.
Throughout 2017, the health care and life sciences industries experienced a widespread proliferation of digital health innovation that presents challenges to traditional notions of health care delivery and payment as well as product research, development and commercialization for both long-standing and new stakeholders. At the same time, lawmakers and regulators made meaningful progress toward modernizing the existing legal framework in a way that will both adequately protect patients and consumers and support and encourage continued innovation, but their efforts have not kept pace with what has become the light speed of innovation. As a result, some obstacles, misalignment and ambiguity remain.
We are pleased to bring you this review of key developments that shaped digital health in 2017, along with planning considerations and predictions for the digital health frontier in the year ahead.
Jennifer Geetter and Dale Van Demark wrote this bylined article on how companies must manage and govern their use of digital healthcare information assets. “Organizations will need to design and implement digital governance structures that … include additional components and organizational stakeholders, in order to meet the business and strategic demands of the digital health revolution,” the authors wrote.
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