Health Law Advisor

On May 17, 2016, FDA issued Draft Guidance for Industry on Use of Electronic Health Record Data in Clinical Investigations ("Draft Guidance").  This Draft Guidance builds on prior FDA guidance on Computerized Systems Used in Clinical Investigations and Electronic Source Data in Clinical Investigations, and provides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 Electronic Health Record ("EHR") data to clinical investigators, research institutions and sponsors of clinical research on drugs, biologics, medical devices and combination products conducted under an ...

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 prescribing drugs, and explicitly outlaws prescribing on “the internet” without a prior examination.  These restrictions vary from state to state, but many share certain ...

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 Act.  Although the Online Pharmacy Act is primarily intended to put an end to illegitimate pharmacies and the fraudulent sale of drugs online, as the American Telemedicine Association, HealthLeaders