| research
(Florida)
Florida statutes
contain some provisions which are very supportive of the practice
of research. In particular, FL Stat 405.01 allows the release
of medical information to "certain study groups"
for research purposes:
"Any person,
hospital, assisted living facility, hospice, sanatorium,
nursing or rest home or other organization may provide information,
interviews, reports, statements, memoranda, or other data
relating to the condition and treatment of any person to
research groups, governmental health agencies, medical associations
and societies, and in-hospital medical staff committees,
to be used in the course of any study for the purpose of
reducing morbidity or mortality."
This statute further
provides immunity from "liability of any kind" for
release of such information, or for publication of findings
and conclusions based on it. (405.01)
"Research
groups, governmental health agencies, organized medical associations
and societies, and in-hospital medical staff committees"
receiving such information must use or publish the material
"only for the purpose of advancing medical research or
medical education in the interest of reducing morbidity or
mortality." Summaries for general publication are also
expressly permitted. (405.02)
The identities
of persons whose condition or treatment has been studied must
be kept confidential. Identifiable research information in
the hands of public agencies is exempt from public records
disclosure provisions. (405.03)
Such
provisions are, however, difficult to reconcile with limitations
in other statutes on medical
records owners. In general, such owners may not furnish
a patient's medical
records to, or discuss the medical condition of a patient
with, any person other than the patient or the patient's legal
representative, or other health care practitioners and providers
involved in the care or treatment of the patient, except upon
written authorization
of the patient. (456.057)
Research uses are
permitted by the latter statutes, but only:
- "[f]or
statistical and scientific research, provided the information
is abstracted in such a way as to protect the identity of
the patient"; or
- "provided
written permission is received from the patient or the patient's
legal representative." (456.057)
(Note that the
statutes offer neither a definition of nor procedures for
"abstracting" data similar to HIPAA's specifications
for de-identified
information or a limited
data set.)
Strictly speaking,
these latter limitations on records owners do not apply to
hospitals and ambulatory surgical centers, which are regulated
separately (by chapter 395). While the section of the Florida
statutes applicable to such facilities generally lists similar
restrictions on use and disclosure of medical records absent
"consent," it does not mention research. (See the
list at 395.3025)
Nothing in the
statutory language implies that a class of providers or facilities
should be subject to dramatically different requirements as
regards use and disclosure of medical records. So the failure
to mention research uses in the context of hospitals and ASCs
is somewhat puzzling. However, the broad disclosure exemptions
elsewhere (viz., in chapter 405 above) suggest few limits
from state law.
Given the state's
rather schizophrenic positions, federal law -- viz., the Common
Rule, FDA regulations, and now HIPAA -- would seem to be the
best guide for limitations on information uses and disclosures
for research purposes.
Note, however,
that Florida statutes extend extra confidentiality protections
to certain kinds of health data -- e.g., related to genetic
information, HIV/AIDS,
mental health and
substance abuse.
Since these are "stricter" than HIPAA's provisions,
they would not be preempted.
See also:
Last modified:
15-May-2005
[RC]
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