On May 17, 2016, FDA issued Draft Guidance for Industry on Use of Electronic Health Record Data in Clinical Investigations (“Draft Guidance”). This Draft Guidance builds on prior FDA guidance on Computerized Systems Used in Clinical Investigations and Electronic Source Data in Clinical Investigations, and provides information on FDA’s expectations for the use of
drugs
Prescription Drug Laws Create Challenges for Telehealth
By Ross Friedberg on
While tremendous strides continue to be made in the growth and adoption of telehealth services, significant legal obstacles remain. Among these obstacles are state drug prescribing laws. In many states, physicians cannot lawfully prescribe drugs during a telehealth encounter, except in very limited circumstances. For example, California requires that physicians perform a “physical exam” before …
Proposed Drug Safety Bill Could Have Implications for Telemedicine Prescribing
By Ross Friedberg on
There is a proposal moving through Congress that has some interesting implications for telemedicine. Sen. Diane Feinstein (D-CA) and Rep. Bill Cassidy (R-LA) have proposed an amendment to the Online Pharmacy Safety Act that would impose additional restrictions on when and under what circumstances practitioners can prescribe medication under the Federal Food, Drug, and Cosmetic…