Digital Health
- Provide multidisciplinary legal support on a range of matters, including state data privacy laws, HIPAA, strategic contracting, and FDA compliance for a leading digital health company that offers its health plan and employer customers a user-centric digital therapeutics platform focusing on multi-chronic conditions.
- Provided legal and regulatory advice in connection with a consumer app software collecting information on symptoms, providing guidance on commercial agreements and new feature development.
- Advised on legal and regulatory issues surrounding the market launch of a software solution designed to gather patient data from peripheral devices and coordinate a communication and management platform with the user’s physician, including advising on licensing arrangements, clinical study agreements, and quality and supply agreements.
- Handled the telemedicine and corporate practice of medicine diligence work in connection with a client’s purchase of a nationwide teleradiology practice.
- Represented a client in connection with an Office for Civil Rights (OCR) HIPAA compliance letter requesting information on the client’s practices around tracking technologies. Our work included assisting the client with the submission of all responses and required documentation to OCR.
- Provided a reimbursement landscape assessment, specific to private insurance coverage policies, for a new medical device company. The assessment involved a coding analysis, a survey of coverage practices and categorization of such coverage policies into trends, and overall reimbursement landscape advice.
- Advised a client that offers a monitoring service to hospitals and physicians through a smartphone application on whether its provision of medical equipment (a scale and a blood pressure cuff) to pregnant women could implicate the beneficiary inducement prohibition in the federal civil monetary penalties law.
- Provided strategic advice to a clinical data analytics firm on compliance with evolving federal and state privacy and security requirements and simplifying transactions administratively while maximizing the utility data for its customers.
- Represented an international diagnostics and laboratory services company in a negotiation of an agreement with a health IT company in which the laboratory company will resell the health IT company’s Electronic Medical Record (EMR) solution to its clients.
- Advised an online behavioral health company on online contracting, licensing, distribution, and privacy and security matters.
- Negotiated an agreement with a health IT company on behalf of a large health care system, including licensing the IT company’s data warehouse product and purchasing implementation and maintenance services.
- Represented a large hospital system in connection with its telemedicine initiatives and related corporate structuring issues. Our work included setting up a physician organization and qualifying that organization to provide services in multiple states.
- Represented the State of Vermont in the negotiation of major systems integration, infrastructure, and cloud services contracts for the establishment and ongoing operation of the state health insurance exchange.
- Represented a large academic health system and affiliated medical school in connection with an investment in, and a beta test agreement with, a data analytics company.
Case Study
Mintz has advised a digital therapeutics company focused on the management of chronic conditions on complex state and federal regulatory landscape, key contracts, FDA rules, and privacy and data security issues.
Case Study
Mintz has provided strategic guidance to Folx Health, a digital company serving the LGBTQ+ community, on federal and state regulations, corporate practice issues and telehealth requirements, an internal restructuring, and day-to-day legal issues.
Case Study
Mintz advised a health care analytics software provider on its rights to health data and the compliance responsibilities of electronic health record (EHR) vendors under the National Coordinator for Health Information Technology (ONC)’s Information Blocking Rule.
Case Study
Mintz attorneys served as lead lawyers in the negotiation of a transaction for the procurement of a software as a service (SaaS) care management platform. The resulting arrangement greatly bolstered our client's bottom line.
Case Study
Mintz was lead counsel to Beth Israel Deaconess Medical Center in the sale of BIDMC’s hospital-built electronic health records platform to Athenahealth. Mintz also helped negotiate an agreement for BIDMC’s physician network to use the multiuse Athena’s platform.
Case Study
Mintz’s Health Law attorneys advised telehealth technology company American Well on state regulatory issues related to developing a national medical group with 24 / 7 availability. The firm’s Corporate attorneys handled the technology licensing and contracts with partners.
Case Study
Mintz helped a digital health company develop corrective actions following a manufacturing inspection related to its Class 1 medical device. After the FDA deemed the company’s health tracking mobile application a regulated device, Mintz submitted an advocacy position paper to the agency.