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Psychedelics have the potential to treat chronic conditions such as post-traumatic stress disorder (PTSD), depression, obsessive-compulsive disorder (OCD), fibromyalgia, and various behavioral health conditions, yet psychedelics are not like traditional pharmaceuticals. The mode of administration often involves a psychotherapy component, necessitating a closer patient-physician relationship and making risk management crucial. In this post, we delve into the critical legal factors that researchers and practitioners must consider before embarking on psychedelic clinical trials. From the intricacies of Food and Drug Administration (FDA) approval for Investigational New Drug (IND) applications to the imperative Drug Enforcement Administration (DEA) registration, site selection criteria, harnessing digital health technologies, and the ongoing and essential nature of informed consent, each factor plays a pivotal role in ensuring the ethical, legal, and safe exploration of psychedelics in the clinical realm. Let’s unravel these legal considerations that pave the way for responsible and groundbreaking advancements in psychedelic medicine.

Amid the growing interest in psychedelic-assisted psychotherapy, especially with substances like MDMA, psilocybin, and ketamine, it becomes imperative to navigate the intricate landscape of legal considerations associated with this burgeoning field. While the therapeutic benefits are promising, each substance brings along its own set of risks, responsibilities, and legal complexities for providers. In this context, the establishment of ketamine clinics demands a comprehensive understanding of the legal framework. Five major legal areas should be examined when considering opening a ketamine clinic, ensuring compliance, and fostering a secure and ethically sound environment. These considerations span corporate formation, physician-psychotherapist agreements, the development of employee handbooks, insurance coverage, and the crucial distinction between independent contractors and employees. Let’s delve into these key legal facets that make for responsible and legally compliant practices within the realm of psychedelic medicine.

The Department of Justice (DOJ) recently announced a $155 million settlement agreement with an electronic health records (EHR) vendor, eClinicalWorks (ECW), to settle False Claims Act allegations against the company initially brought by a whistleblower/qui tam relator.  The whistleblower was a software technician for the City of New York City who was implementing ECW software in a prison healthcare system.  The DOJ subsequently intervened and filed suit.  The May 31, 2017 announcement is the first of its kind, holding an EHR vendor accountable for claims made about their certifications.

Provider clients of ECW relied on the assertions made by ECW that their EHR software met the criteria of the Office of the National Coordinator of Health Information Technology (ONC) certification program.  Based on ECW’s software and the assertion of EHR certification, providers believed they had achieved “meaningful use” and received incentive payments under the Medicare and Medicaid EHR Incentive Programs.