As recognized leaders in pioneering healthcare and life sciences ventures (including in telemedicine, genomics, biologic products, medical devices, behavioral health, cannabis, and psychedelics), Nelson Hardiman has been closely linked to many of the most well-known innovative ventures in healthcare and life science. On multiple occasions, we have become known as the “go-to” firm for advice that can be hard to find.
Thanks to our expertise in both FDA and state practice-of-medicine legal issues, our advice has been critical to the launch of many telemedicine and next generation health technology ventures. We have learned to work well with early stage companies and to be effective navigators of the journey from start-up to mature company or acquisition target. Informed by our unique depth of experience in the health tech niche, our seasoned attorneys bring unique and hard-earned insights into the pathway to liquidity events in healthcare and life sciences industries. Deeply immersed in the transformation and the future of U.S. healthcare, we are uniquely positioned to advise start-up healthcare ventures on their business and regulatory needs.
The complex federal and state regulations that govern healthcare business operations make it essential to “kick the tires” on any new healthcare business launch. We apply our in-depth legal knowledge and experience to assess the regulatory issues inherent in new ventures, from corporate practice of medicine (CPOM), privacy and data security (HIPAA), and Stark/Anti-Kickback concerns to compliance with telemedicine regulations. We blend a track record of successful start-ups with a focus on opportunities driven by healthcare transformation to provide problem-solving legal counsel and strategic support to healthcare entrepreneurs. Clients depend on Nelson Hardiman to tackle their business and regulatory risks head-on and turn their visions into realities.
Our Work Includes:
- Digital Health Advised digital health company on compliance and risk management strategy in servicing Medicare beneficiaries and contracting with Medicare and in-network healthcare providers.
- Home Sleep Diagnostic Business Defended neurofeedback device manufacturer in FDA investigation and response to warning letter.
- Male Medical Clinics Advised on FDA and related regulatory issues for a group of clinics focusing on erectile dysfunction.
- Telehealth Worked with the leadership and physicians of a leading telehealth company to develop the regulatory pathway to a model that represents the future of digital health.
- Telehealth Advised a telehealth company regarding regulatory and operational issues for providing telemedicine services across state lines.
- Telehealth Advised national telehealth provider on multi-state licensing, compliance, reimbursement, patient privacy, and standard of care issues.
- Telemedicine Advised a start-up telemedicine venture focusing on customized nutritional assessments and weight loss.
- Teleradiology Software Provider Advised national teleradiology provider on compliance program for corporate practice of medicine issues in all “corporate practice” states.
- Weight Loss Clinics Counseled a chain of weight loss clinics on business plan development, providing expertise on telemedicine, corporate practice of medicine, scope of practice, fee splitting, anti-kickback, and other healthcare regulatory issues.