Public Health Law Map - Beta 5 - Medical and Public Health Law Site

when they were designing research studies. This is necessary to determine what
information is available, what form it is in, and how the study must be designed to
retrieve the information. HIPAA continues this exception to the right of patients to
control access to their medical information for non- treatment purposes, but with
certain limitations. The access is limited to preparatory research, it cannot be a ruse
to do research on the PHI without satisfying IRB requirements. The information must
be necessary for the preparation. Most importantly, the information cannot be taken
from the covered entity. This includes copies of the information or excepts in the
researcher's notes. The researcher can only review the records but cannot extract data
from them. This exception applies to the HIPAA requirements on access to records,
unless the preparatory research meets one of the exemptions from the Common Rule,
it is still subject to IRB review.
I. Conclusions
HIPAA works from the premise that individuals should control their own personal
health information. HIPAA has significant exceptions to allow medical care to be
provided to the patient without unduly burdensome paperwork requirements. HIPAA
also have broad exceptions for research access to records, but these still make certain
types of research much more burdensome or impossible to do. As discussed in the
Public Health section, there are also significant exceptions to HIPAA for public health
investigations.
HIPAA does provide some useful additional protections for patient privacy and it gives
patients better control over their medical information. This comes at a significant cost
to hospitals and other medical care providers, as well to medical research. Given the
numerous exceptions to HIPAA, which privacy advocates argue really allow most of
the practices they are concerned about, it is not clear that HIPAA will be worth its cost.
Only time can answer that question.
XII. Medical Records
HIGHLIGHTS
Introduction
Improper medical records can subject medical care practitioners to civil and
criminal liability.
Medical records must meet federal standards for documentation.
Even informal medical encounters should be documented.
Patient confidentiality must be respected when releasing medical records.
Medical records must never be altered or fabricated.
Traditionally, there were two major legal issues in medical records management: how
would the medical record be used in possible medical malpractice litigation; and who
362