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

drug. The trial is a success and the drug company is applying to the FDA for a
license to market the drug. This permit, as described in the FDA section, requires
the FDA to review the clinical trial data to assure that the drug is safe and effective.
If your data has to be removed from the clinical database, it will could make the
necessary analysis impossible and keep the drug from being approved.
c) Preventing Unauthorized Release
A physician has a duty to ensure that information is released only to properly
authorized individuals. Assume, for example, that a patient has signed an
authorization to release information to an employer. The medical care practitioner
can legally release information to the employer, but he or she must ensure that the
person requesting the information is the one authorized to have it. This might
require that the information be sent to the personnel department rather than be
given to a caller on the telephone.
If someone presents an authorization that the patient has signed, the medical care
practitioner should endeavor to determine if the release is valid. If the release is
over a few months old or appears irregular, the medical care practitioner should
attempt to contact the patient before releasing the information. If the patient cannot
be located, the medical care practitioner should contact the person seeking the
information and try to verify the authenticity of the release. If the medical care
practitioner is still suspicious, he or she should request that the person seeking the
information have the patient contact the office. Medical care practitioners should
also be wary of subpoenas. In many states, these can be issued without supervision
by a judge, and they are very easy to forge. The medical care practitioner should
insist on a signed release from the patient, and should call the law office listed on
the subpoena to assure that the subpoena is valid. The best policy is to have the
office staff contact the patient and tell them about the subpoena before turning over
the records.
A physician has a right to charge a nominal fee for a copy of the patient’s medical
record. This fee should reflect the actual charge for copying the chart. If the patient
is indigent, the physician should provide the chart or an appropriate summary at no
cost. Under no circumstances should the physician attempt to hold the chart hostage
for an unpaid medical fee or to prevent the patient from seeking care elsewhere.
This is bad public relations and may cause the patient to sue to obtain the record.
4. When Can PHI Be Released without Authorization?
The major exception to the need for specific authorization for the release of PHI is
that medical care providers may release information to other providers and entities
who are participating in the patient's care, and to business that provide services for
those providers. Physicians do not need a specific authorization to share information
with specialty consultants they talk to, with labs performing medical testing, or with
a billing service who prepares the physicians' bills. These business that provide
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