A Message About HIPAA Compliance for Reporters
to FDA MedWatch
You can continue to make
adverse event reports under the Health Insurance Portability
and Accountability Act (HIPAA) Privacy Rule. The HIPAA Privacy Rule is not intended to disrupt
or discourage adverse event reporting in any way. In fact,
the Privacy Rule specifically permits covered entities (such
as pharmacists, physicians or hospitals) to report adverse
events and other information related to the quality, effectiveness
and safety of FDA-regulated products both to the manufacturers
and directly to FDA.
"The HIPAA Privacy Rule recognizes the
legitimate need for public health authorities and others
responsible for ensuring public health and safety to have
access to protected health information to carry out their
public health mission. The Rule also recognizes that public
health reports made by covered entities are an important
means of identifying threats to the health and safety of
the public at large, as well as individuals. Accordingly,
the Rule permits covered entities to disclose protected
health information without authorization for specified
public health purposes."
(From OCR
Guidance Explaining Significant Aspects of the Privacy Rule - DISCLOSURES FOR
PUBLIC HEALTH ACTIVITIES, page 28. See also 45
CFR 164.512(b)(1)(i) and (iii))
In order to keep effective drugs and devices available on
the market for use by you and your patients, FDA relies on
the voluntary reporting of serious adverse events or product
problems that you suspect are associated with a drug or medical
device you have used, prescribed or dispensed. FDA uses these
data to maintain our safety surveillance of all FDA-regulated
products. Your report may be the critical action that prompts
a modification in use or design of the product, improves
the understanding of the safety profile of the drug or device
and leads to increased patient safety.
You should bear in mind that the Privacy Rule requires that
you make a reasonable effort to submit the minimum protected
health information necessary to achieve the purpose of your
report. See 45 CFR 164.502(b) and 164.514(d).
Related Links
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Full
Text of the Privacy Rule
(see section 164.512 [Uses and disclosures for which
an authorization or opportunity to agree or object
is not required])
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