Distance Learning

An Update on FDA Regulation of Telemedicine - On Demand Recording

Recorded On: 03/21/2017

Time: 90 minutes
Session Format: On Demand Recording

This webinar is designed to provide the big picture overview of what gets regulated and what does not with regard to telehealth under the Federal Food Drug and Cosmetic Act, including the mobile medical app guidance. In particular, the webinar will focus on the importance of intended use. The webinar also will provide a deep dive into the December 2017 draft guidance documents on Clinical and Patient Decision Support Software, as well as Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act.  That pair of guidance’s was released for comment to address FDA's overall approach to important categories of software including CDS, wellness and the software used for data collection and storage. In addition, the webinar will provide an overview of practical issues involved in FDA regulation of telemedicine, including a discussion of the FDA's current pilot program on precertification, the agency's approach to quality and compliance, MDR reporting and international developments at the IMDRF.

Level of Difficulty: Intermediate

Intermediate-level programs generally offer focused discussions regarding common legal issues pertaining to the program topic. Intermediate programs include legal updates and changes in the law. Speakers will assume the audience has a working knowledge of this specialty of health law, and there will be limited review of the fundamentals. This program is designed to provide a targeted, comprehensive analysis of the subject matter for those practicing law in this specialty for three to seven years and/or those whose practice is periodically focused in the covered subject area.

  • AHLA Member: $145
  • Non-AHLA Member: $275

Sponsoring AHLA Group:

  • Hospitals and Health Systems Practice Group

Co-sponsoring AHLA Groups:

  • Fraud & Abuse Practice Group
  • Health Information & Technology 
  • In-House Council Practice Group
  • Medical Staff Credentialing and Peer Review Practice Group
  • Physician Organizations Practice Group
  • Payers, Plans and Managed Care Practice Group
  • Regulation, Accreditation and Payment Practice Group
  • Tax & Finance Practice Group
  • Enterprise Risk and Management Task Force Practice Group
  • Children’s Hospital Affinity Group Practice Group

On-Demand+CLE Webinars

On-Demand+CLE webinars are eligible for Continuing Legal Education (CLE) credit and are approved in every state with mandatory CLE requirements for attorneys unless otherwise specified. Please refer to the Distance Learning CLE State Chart for details regarding specific state guidelines.

On-Demand Webinars

Offerings designated as “On-Demand" differ from those designated as “On-Demand+CLE" in that they are CLE-ineligible. However, CLE credit may be obtained by applying directly to the attorney's state accrediting body, but approval is not guaranteed and is at the discretion of said accrediting body and subject to its rules and regulations. Please refer to the Distance Learning CLE State for details regarding specific state guidelines.

Other, Non-CLE Credits

AHLA On-Demand+CLE webinars are only approved for CLE credits unless otherwise stated. To obtain other credit types (Continuing Professional Education, Compliance Certification Board, Nursing Home Administrator, etc.) participants may apply directly their desired licensing body, but approval is not guaranteed and is at the discretion of said licensing body and subject to its rules and regulations.

For additional information about Distance Learning-related credits, please email the Practice Groups staff at pgs@healthlawyers.org.

It is recommended that you use a high speed/broadband internet connect (Wifi is not recommended), a PC with Windows and Internet Explorer 11 or higher. If you are using a Mac, please use the Safari web browser.