HHS Publishes Final Rule on Patient Access to Their Lab results
and Human Services (HHS) has issued a final rule that requires laboratories to
give patients access to their lab results. A
few years ago Health and Human Services Secretary Kathleen Sebelius reaffirmed
the Obama Administration commitment to patient-centered care.
part of that initiative, she indicated, had to include a re-assessment of the
whole idea of who owns the patient’s information.
had always believed that the patient could have access to their medical
records, but even in that context, providers maintained that certain notes
could still be withheld from the patient as not a material or essential part of the record. HIPAA (the Health Insurance Portability and
Accountability Act of 1996) laid out very specific restrictions on the
handling, storage, protection, and sharing or disclosing of patient information.
In addition many states severely restricted the release of laboratory results.
In most states, lab results can only be released to the ordering provider with very few exceptions.
new final rule by HHS says that patients own their results and have the right to receive access to their
lab results. In other words, laboratories must establish a clear process for
providing patients with their results if and when patients request such results.
CLIA’88 and HIPAA had to be amended to allow this expanded access. Patients may
still continue to receive results from their provider, of course. But under the new
mandate, laboratories must give requested results (including an electronic
copy) to the patient and/or the patient’s designated representative. Requested
results must be provided within 30 days.
Final Rule goes into effect April 5, with all covered entities mandated to
comply by October 2 of this year.
final rule is available at www.federalregister.gov
will your lab comply with this new mandate?