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
Remember how Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), dismissed the §510k "substantially equivalence" medical device clearance as non-preemptive because it was supposedly "focused on equivalence, not safety"? Id. at 493.
The US Food and Drug Administration (FDA) related portions of the 21st Century Cares Act, found in title III, establish a streamlined process for the exemption of certain Class I and II devices from the premarket notification requirement and allow for the establishment of revised regulatory standards for accessories to high-risk devices.
Hospitals are commonly named as defendants in medical malpractice lawsuits for claims arising from alleged injuries within their walls, but what is their exposure to liability for claims that arise from alleged sexual assaults by staff on their premises?
Eric Fader was quoted in a November 9 article, "Incoming Trump Administration May Mean Less Funding for HIPAA Audits," in Bloomberg BNA's Health Care Fraud Report. Eric said that the incoming Trump administration may eventually be forced to reduce funding for some healthcare initiatives to pay for other priorities, such as large tax cuts and increased spending on the military.
Title III of the 21st Century Cures Act includes portions of the FDA Device Accountability Act of 2015, Promoting Biomedical Research and Public Health for Patients Act, and FDA and NIH Workforce Authorities Modernization Act.
A February 2 article in Bloomberg BNA's Privacy Law Watch and other publications, "Hospital Hit With $3.2M Penalty for Ongoing Health Data Security Lapses," reported that Children's Medical Center of Dallas received a $3.2 million civil money penalty after years of noncompliance with HIPAA rules and after failing to request a hearing on the penalty.
The 21st Century Cures Act includes portions of the Helping Families in Mental Health Crisis Reform Act of 2016, which was approved by the US House of Representatives in July 2016, but not advanced by the Senate.
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