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Driving Tomorrow’s Advances in the Health Care and Life Sciences Ecosystems

�鶹��ý is primed to strategically advise health care and life sciences companies through every step of their journey and all stages of their lifecycle. Companies in this space require experience and resources to navigate rapidly accelerating digital technologies and shifting regulatory and IP environments that complicate the development of new tests, treatments, and business models. We provide business and legal solutions so you remain competitive in a constantly evolving market.

Our more than 200 dedicated health care and life sciences attorneys in 25 offices across the country help our clients grow, empowering their business strategies and operating models to position them for success today and in the future. We recognize that speed matters in this evolving space where new legal challenges emerge daily. �鶹��ý excels at marshaling rapid-response teams to address clients’ needs quickly. Whether reacting to a data breach or facing a government investigation, we organize teams swiftly from offices across the United States to create tailored solutions that address your most pressing issues.

�鶹��ý is the preeminent law firm for telemedicine and digital health, health care providers and payors, academic medical centers, entrepreneurs, pharmaceutical and biotechnology firms, laboratories, clinical research organizations, behavioral health and home health providers, and investors in the industry. We offer the full scope of legal services and provide turnkey solutions that bring to the table deep knowledge and experience in all facets of transactions, regulatory and compliance, data intelligence, IP, privacy and cybersecurity, and licensing and collaborating agreements. With deep regulatory experience coupled with a national transaction backbone, �鶹��ý delivers a one-stop solution for companies and investors. We have decades of in-house experience at health care providers and vendors, pharmaceutical and biotechnology firms, as well as key state and federal government agencies. Our lawyers have been deeply immersed in these industries, acquiring substantial technical and scientific knowledge through graduate degrees and ongoing training that enables us to provide forward-looking, practical solutions.

Table of Contents

1. Is Your Digital Health Product or Service Subject to FDA Regulations?
2. Psychedelic Drugs – Easing the Regulatory Hurdles for Development
3. Growing Scrutiny to Private Equity in Health Care
4. 2023 M&A Outlook
5. Priorities of the 118^th Congress and the Biden Administration
6. Medicare Remote Therapeutic Monitoring: Top FAQs for 2023
7. CMS Finalizes Changes for Telehealth Services for 2023
8. Another Extension of Telehealth Relief for HDHP/HSA Plans
9. Acute Hospital Care at Home: Omnibus Bill Extends Flexibility Period to December 31, 2024
10. The BioPharma Patent Cliff: 2023 and Beyond
11. Considerations When Conducting Decentralized Clinical Trials
12. Framing FDA Regulatory Compliance and Patenting Strategy for Artificial (AI)-Based Software as a Medical Device (SaMD)