Digital Health

Protection of IT intellectual property is in Lee & Hayes’ DNA.  Unlike most IP firms, we have the FDA expertise needed to help clients answer the critical question: “Are we a medical device?”  Lee & Hayes’ attorneys provide insight on the intellectual property, FDA, business, and financial considerations facing organizations who are developing and/or selling digital health systems or apps. We help our clients identify and protect their assets, ensure regulatory compliance, create licenses and collaborative agreements, finance growth and expansion, and enforce their rights through litigation and other means of dispute resolution.  A unique capability of Lee & Hayes is strategic integration of our IP and FDA counseling.

We have experience advising:

• Leading vendors of hospital information software on the FDA regulatory status of their systems
• Developers of mobile apps in the wellness and/or medical space on regulatory compliance
• Major medical device manufacturers regarding international data governance policies, launching international informatics businesses as well as the data handling, security, and compliance issues related to their products and services
• Leading global pharmaceutical organizations in the development of digital media governance programs

Knowledgeable about both physiology and information technology, our attorneys have worked on technologies including digital health and medical records, networked medical devices, encryption, wearables, AI and use of Big Data as clinical decision support software, bioinformatics, and genetic analysis.  Our FDA and regulatory practice helps clients strategically position their software as consumer devices or medical devices, assists medical device clients comply with applicable FDA requirements and advises clients on compliance with HIPAA. Whatever your needs, Lee & Hayes is unique in offering our digital health IT clients both intellectual property and FDA/regulatory advice and strategic counseling.