Mintz Advises Digital Health Company in Chronic Care Management Space
Key Facts
- The client developed a digital care management platform for diabetes patients
- As the client expanded its products and services, Mintz advised on the complex state and federal regulatory landscape and key contracts
- Mintz provides ongoing legal support as the company continues to add new product offerings, expand its commercial channels, and improve user experience and outcomes
The Situation
Mintz was initially engaged to provide legal support for the client’s health plan and employer customer agreements. As the client developed innovative digital health solutions in the musculoskeletal and behavioral health areas, the client turned to us to update its enterprise-wide data privacy and security program, advise on complex FDA rules, and negotiate a strategic collaboration agreement.
The Approach
Mintz attorneys with deep state privacy law and HIPAA experience updated the company’s privacy policies and its HIPAA Business Associate Agreements. Our authority on FDA laws and regulations analyzed the company’s AI-driven platform against the FDA’s clinical decision support software guidance documents. Our corporate attorneys drafted and negotiated a multiyear co-promotion, development collaboration, and license agreement with a strategic partner.
The Outcome
Mintz continues to provide sophisticated health regulatory and data privacy support to the company, which has become a leader in the digital therapeutics market.
