An Update on FDA Regulation of Telemedicine
Time: 2:00-3:30 PM Eastern (90 minutes)
Session Format: Live Webinar
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 The webinar also will provide a deep dive into the December 2017 draft guidance documents on Clinical and Patient Decision Support Software, as well as Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st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.
- Member of Sponsoring Practice Group(s) (see "Sponsor(s)" tab for details): $99
- Government, Academician, Public Interest, or Solo Practitioner AHLA Member: $75
- Student, Paralegal, or Retired AHLA Member: $50
- Other AHLA Member: $150
- Non-AHLA Member: $325
- AHLA Member Listen with a Colleague Option (see "Listen with a Colleague" tab for details): $75
- AHLA Non-Member Listen with a Colleague Option (see "Listen with a Colleague" tab for details): $95
Sponsoring AHLA Group:
- Health Information & Technology
Co-sponsoring AHLA Groups:
- Fraud & Abuse Practice Group
- Hospitals and Health Systems Practice Group
- 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
- Children’s Hospital Affinity Group
Live webinars are eligible for Continuing Legal Education (CLE) credit. Please refer to the Distance Learning CLE State Chart for details regarding specific state guidelines.
- For attorneys licensed in states in which live distance learning programs are approved and AHLA possesses approved provider/sponsor status: AHLA webinars are pre-approved for CLE credit. Certificates of completion are made available immediately following the webinar upon completion of the course evaluation. Those states are: Indiana, Louisiana, New Jersey, New York, Pennsylvania, and Virginia.
- For attorneys licensed in states in which live distance learning programs are approved and AHLA does not possess approved provider/sponsor status: participants are able to apply directly to their state accrediting body for approval for and accreditation of AHLA-sponsored webinars. The application and agenda are available for download during the live event and any time thereafter; certificates of completion are made available immediately following the webinar upon completion of the course evaluation.
- In states in which live distance learning programs are not approved, it is still possible to obtain CLE credit by applying directly to the state's accrediting body for “self-study" credit where applicable.
Other, Non-CLE Credits
AHLA webinars are only presumptively 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 email@example.com.
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It is recommended that you use a high speed/broadband internet connect (Wifi is not recommended), a PC with Windows and Internet Explorer 9.0 or higher. If you are using a Mac, please use the Safari web browser.
The “Listen with a Colleague" option allows multiple registrants from the same organization and location to participate in the webinar at a discounted rate. It may ONLY be used if at least one person from your organization and location has registered at the regular/full webinar registration rate. Please note that those who register under the reduced “Listen with a Colleague" rate must access the webinar from the same location and computer as the full-priced registrant they are registered under.
The “Listen with a Colleague" option is continuing legal education (CLE) credit-eligible. In order to obtain a certificate of completion for submission to a state CLE accrediting body, those registered under this option must obtain the attendance verification code—which will be displayed at a random time during the webinar—and enter that code under “Verification Code for Live Webinar" section of the webinar description webpage. Please note that each registrant must submit a complete evaluation from their individual accounts to obtain a certificate of completion.
If you have any questions about this registration option, please contact customer support.