Beyond Product Launch: Navigating FDA Post-Market Requirements for mHealth and Health IT

^{mHealth and Emerging Technologies: Changing Healthcare Delivery}

Providing an In-Depth Look at the Regulatory Landscape: A Webcast Series

Mobile Health and Health IT are revolutionizing the healthcare industry. From Electronic Health Records (EHRs) that provide real-time coordination of patient care to mobile applications and Clinical Decision Support (CDS) tools that track patient symptoms and adherence to treatment regimens, healthcare technology is rapidly changing established healthcare delivery models. The convergence of new technology and established legal principles requires practical and innovative approaches to addressing legal and regulatory issues, including medical device regulation, coverage and reimbursement, healthcare compliance, advertising and promotion, privacy and data security, and litigation and risk management. These issues affect everyone across the care continuum from patients, providers, and payers to developers and regulatory and compliance personnel. The mHealth and Emerging Technologies Group at Arnold & Porter combines diverse subject-matter experience, deep industry knowledge, and innovative thinking to help our clients navigate the complex legal and regulatory issues in this thriving and constantly evolving industry.

We invite you to join us for our 2015 Health IT Webcast series. Through a series of informative programs described below, our team will share insights and best practices on issues ranging from FDA and healthcare compliance to litigation and compliance risk management.

• Beyond Product Launch: Navigating FDA Post-Market Requirements for mHealth and Health IT
• Connecting Through mHealth Solutions: Fraud & Abuse Implications for Patient, Physician, ACO, Hospital and Industry Partner Engagement Models
• Is Medicare Ready for the mHealth and Emerging Technologies Revolution?
• Staying Ahead of the Curve: Managing Advertising, Privacy and Security Issues for Consumer-Directed Mobile Apps and Health IT
• Managing Litigation and Compliance Risks: Are mHealth and Health IT the New Frontier for Products Liability and Enforcement?

Beyond Product Launch: Navigating FDA Post-Market Requirements for mHealth and Health IT

FDA has removed pre-market clearance and other medical device requirements for many mobile apps and Health IT tools, but the agency is encouraging developers of both regulated and unregulated mHealth and Health IT solutions to adopt device quality system principles. With FDA and other stakeholders focusing on quality, interoperability, data integrity and data transfer issues, developers must adopt quality and regulatory management processes that are scalable and appropriate to address the fast-paced and ever-evolving product development life-cycle for software and Health IT. This webcast addresses implementation of FDA post-market quality and safety requirements and recommendations for mHealth and Health IT solutions including topics such as labeling, cGMP/QSR and complaint handling, and adverse event reporting.