We help you navigate and understand the associated legal risks and requirements as you develop, use and invest in new health care technologies.
Digital health technologies are creating opportunities for new players to “disrupt” the industry, identify new methods to create efficiencies, engage stakeholders and provide new opportunities for patients to actively participate in their health management. With these novel innovations and opportunities come myriad risks and legal concerns that health care providers and digital health vendors must understand and address.
Identifying and unraveling barriers is one of the things we do best. We apply our deep industry and regulatory knowledge, acting as translators between the digital health innovator or health care provider and regulators, ensuring that our clients’ new technologies can be integrated into mainstream health care delivery while protecting patient well-being and privacy.
We counsel on critical regulatory and operational issues related to:
- Federal and state licensure and regulatory approval
- Corporate practice of medicine
- Informed consent issues
- Reimbursement issues
- Privacy and security issues
- Fraud and abuse
- IP and licensing issues
- Naming and advertising
- Competitive pricing and discounts
We work with
- Health care service providers
- Technology platform providers
- Medical device manufacturers
- Biotech companies
- Venture capital and private equity firms