Digital Health

Our leading privacy & data security practice regularly advises clients on HIPAA and other privacy laws governing the use and handling of sensitive personal and health information. Additionally, our data breach response team advises clients on internal investigations and helps them establish and test audit and incident responses before a breach occurs.

We are well positioned to help you comply with the rapidly evolving laws, regulations and oversight governing the U.S. and global digital health market. Our FDA regulatory team has extensive experience in all relevant areas, including FDA classification of software as a medical device, device clearance and approval, FDA Quality System Regulation, adverse event reporting, and device labeling. In addition, our FTC regulatory team has extensive experience counseling companies on FTC data privacy issues and handling FTC investigations.

We have also worked closely with both vendors and users to design, develop, license, implement and operate health IT systems that securely and effectively integrate patient health information into a centralized network.

Establishing an intellectual property strategy and obtaining valid patent protection can be challenging for digital health companies. As a result, digital health companies typically rely on a combination of patent, copyright, trade secret and contract rights to protect their businesses. Our attorneys have vast experience helping clients develop and implement a practical protection strategy for the various intellectual property rights on which their businesses depend. Additionally, our IP litigators have a record of courtroom success in a variety of patent infringement, trademark and false advertising cases.

Remaining competitive in the digital health market often requires collaboration, which presents challenges relating to the rapidly changing technological landscape. We are deeply experienced in all aspects of licensing and collaborations relevant to digital health vendors and users, including co-promotion, marketing and distribution agreements, strategic alliances, outsourcing, supply and manufacturing agreements, and joint ventures.

The mix of health care, life sciences and technology companies involved makes investing in the digital health market particularly complex. Our longstanding leadership in M&A and private equity, wide-ranging transactional experience, and long track record in capital markets and private financings give us a thorough understanding of the issues facing digital health investors and companies alike.

Regulators and third parties are increasingly focused on making sure that digital health enterprises have the proper corporate governance safeguards to protect the integrity of the business and its data. We routinely advise companies on critical compliance and governance issues, including the development of structures that promote regular, accountable over- sight and proper employee training.