Cutting Edge Issues in Health Care Technology/mHealth

Chicago Intellectual Property Partner Ira Kalina co-presented Cutting Edge Issues in Health Care Technology/mHealth with Vanessa T. Pollard from Arnold & Porter LLP. Topics covered included:

• The use of mobile technology has become an indispensable part of healthcare in the 21st century. From cloud-based health records to mobile apps that display MRIs on a smart phone, manufacturers and developers are creating innovative solutions that leverage the portability of mobile platforms and software to provide greater access and more efficient delivery of medical care and health information
• These present new legal and regulatory challenges for developers, manufacturers, patients, providers and regulators
• Recently, FDA and other regulators proposed a risk-based regulatory strategy for Health IT to promote innovation, protect patient safety, and avoid regulatory duplication
• For entities developing, licensing, marketing or using healthcare apps or other forms of Health IT, it is important to:
  • Identify the types of Health IT devices subject to regulation
  • Identify practical regulatory and compliance issues that may impact business objectives
  • Understand FDA requirements for development, marketing, safety and quality of medical devices and Health IT
  • Develop a compliance infrastructure to identify and manage potential compliance risks in an increasingly competitive market