Earlier this week, the Food and Drug Administration (FDA) issued
a proposed rule amending its regulations on the acceptance of data
from clinical studies on medical devices. The proposed rule
requires that clinical studies outside the United States as support
for any device-related application or submission –
investigational device exemption (IDE), premarket notification
(510(k)), premarket approval (PMA), product development protocol
(PDP), or humanitarian device exemption (HDE) – have been
conducted in accordance with good clinical practices (GCP).
The proposed rule also requires GCPs to have been followed in
clinical studies conducted inside the US for FDA to accept the data
in support of an IDE or 510(k). For purposes of the proposed rule,
GCPs include "a standard for the design, conduct, performance,
monitoring, auditing, recording, analysis, and reporting of
clinical trials in a way that provides assurance that the data and
reported results are credible and accurate and that the rights,
safety, and well-being of trial subjects are protected." GCPs
further include "review and approval (or provision of a
favorable opinion) by an independent ethics committee (IEC) before
initiating a study, continuing review of an ongoing study by an
IEC, and obtaining and documenting the freely given informed
consent of the subject ... before initiating a study." An
institutional review board (IRB) qualifies as an IEC.
FDA offered four general reasons in support of the proposed
rule: (1) to update its standards for accepting data from clinical
studies on medical devices conducted outside the US; (2) to ensure
the quality and integrity of data; (3) to standardize protections
for human subjects; and, (4) to clarify the requirements for FDA
acceptance of data from clinical studies in support of IDEs and
Recent enforcement actions by the Department of Health and Human Services, Office of Civil Rights underscore a continued focus on compliance with the Health Insurance Portability and Accountability Act and its implementing regulations, particularly the Security Rule.
Last Sunday’s New York Times article by Anemona Hartocollis on the illegality of posting baby pictures in a doctor’s office made me wonder if anyone I know could pick my kids’ faces out of a line up of cute newborn photos posted on the wall of a doctor’s office.
In the world of healthcare policy and law, we usually discuss issues impacting providers, but don’t often report about the training and infrastructure behind what allows our healthcare system to treat patients in our facilities.
CMS's long-awaited fingerprint-based background check screening process is underway for certain "high-risk" providers and suppliers participating in federal health care programs (specifically, Medicare, Medicaid, and the Children’s Health Insurance Program).