The Center for Telehealth and e-Health Law’s (CTeL) Executive Telehealth Fall Summit

FDA partners Elizabeth M. Bierman and Michele Lee Buenafe will present at The Center for Telehealth and e-Health Law’s (CTeL’s) Executive Telehealth Fall Summit.

Are You a Medical Device Manufacturer Without Knowing It?
Thursday, November 17, 2016
2:15–3:00 pm

Medical devices are subject to US Food and Drug Administration (FDA) approval, and failure to have a device approved can swiftly result in sanctions and interruption of your business practice. If your organization has a telehealth technology that includes a peripheral device or other device that engages patients and you license, provide, or sell that technology to parties outside your healthcare system, practice, or hospital, you may be at risk for FDA sanctions.

FDA uses a unique lens to determine if an organization is operating as a medical device manufacturer. Learn what FDA is focusing its sights on and the metrics that it uses to identify organizations that operate as medical device manufacturers subject to FDA oversight.

Participants: Elizabeth M. Bierman and Michele Lee Buenafe

Telehealth Speed Dating with Experts
Thursday, November 17, 2016
3:15–4:00 pm

These break-out sessions offer attendees the opportunity to consult one-on-one with industry experts. Bring your telehealth questions and conundrums in these six areas:

• Cybersecurity
• FDA
• Medical malpractice
• Reimbursement
• Risk management and insurance
• Telemedicine basics

Participants: Michele Buenafe will cover FDA issues during these one-on-one consultations.