Technology is rapidly changing the way health care is delivered. From mobile medical applications that provide information on diseases and treatments to wearable devices that record patient data for use by a physician, the digital health revolution is now, and it reaches far beyond the tech startup community.
Pepper Hamilton LLP’s Digital Health Practice Group advises companies large and small on how health care IT affects them, whether they are a well-established tech company with multiple products or a major pharmaceutical company looking to launch its first app.
We examine our clients’ digital health products from multiple angles, including privacy, regulatory, IP and product liability risk, and we tackle questions about how information is collected, used, transmitted, stored and destroyed. This holistic approach ensures that new products take multiple perspectives into account to help establish compliance with relevant regulations, and that those considerations are incorporated into future products and apps.
Our work includes:
analyzing databases from U.S. and foreign jurisdictions containing molecular data, medical data, drug information and other content to determine rights for use in mobile apps
negotiating licenses with database providers for incorporating databases and their content into mobile apps
counseling on Food and Drug Administration (FDA) and other regulations and guidance on the use of scientific and medical databases and content for apps
negotiating supplier and service provider agreements with laboratories, logistics providers, social media marketing companies and e-commerce solutions providers
advising on the applicability of HIPAA, FDA, Federal Trade Commission and Federal Communications Commission privacy/security regulations and assessing risk, including with regard to geolocation, biometrics and children’s data
providing IP advice on hardware, software and data-related elements of developing mobile platforms and devices
counseling on post-market liability risks, corporate practice of medicine issues, and promotional roadmaps
negotiating and drafting joint development agreements involving the development of predictive analytic models using aggregated real-world and patient-collected data sets