March 24 Webcast: “Beyond Product Launch: Navigating FDA Post-Market Requirements for mHealth and Health IT”

Tomorrow, March 24, Arnold and Porter will be hosting a webcast entitled “Beyond Product Launch: Navigating FDA Post-Market Requirements for mHealth and Health IT.”

Click here to RSVP to this event.

This is the first presentation in Arnold and Porter’s five part 2015 Health IT Webcast series. This presentation focuses on a mobile apps. 

Arnold and Porter states:

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 will address 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.

Speakers:

Vernessa Pollard, Partner, Arnold & Porter LLP, Washington, DC

Philip Desjardins, Counsel, Arnold & Porter LLP, Washington, DC

When: Tuesday, March 24, 2015, 9:00 a.m. (PT), 12:00 p.m. (ET)

This presentation is the first of Arnold and Porter’s 2015 Health IT Webcast series, which include:

• 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?