HHS: Providers can’t use Patient Safety Act to prevent patient access to data

New guidance from HHS’s Office of Civil Rights and the Agency for Healthcare Research and Quality clarified that providers can’t use the Patient Safety Act to stop patients who believed they were harmed from obtaining records about their care.

The 22-page document addressed providers that “may be attempting to misuse the Patient Safety Act protections to avoid their external obligations,” work around federal and state regulations, and withhold individual records that could be used to sue providers.

The guidance included two examples of the way the law has been misinterpreted. First, some providers have been improperly maintaining required records as reports for a patient safety evaluation system (PSES), and claiming those records must be kept confidential. Second, the guidance accused some providers of making duplicate copies of patient records, which should remain accessible, placing them in safety reports and then destroying the originals.

“The Patient Safety Act was not intended to give providers such methods to evade their regulatory obligations,” the guidance said.

The document specifically warned against destroying records, advising providers to exercise “extreme caution” and taking the stance that destroying original documents on which a patient safety work product is based doesn’t absolve the provider from regulatory consequences.

""
John Gregory, Senior Writer

John joined TriMed in 2016, focusing on healthcare policy and regulation. After graduating from Columbia College Chicago, he worked at FM News Chicago and Rivet News Radio, and worked on the state government and politics beat for the Illinois Radio Network. Outside of work, you may find him adding to his never-ending graphic novel collection.

Around the web

“Now more than ever, we must recognize that our country’s leadership in groundbreaking medical research spurs scientific innovation, improves public health and creates new innovations that save and improve lives nationwide,” Joseph C. Wu, MD, PhD, explained in a statement. 

The technology used to diagnose, treat and manage cardiovascular disease is always evolving, keeping FDA officials quite busy. But have the agency's standards been slipping in recent years? A cardiologist with Cedars-Sinai Medical Center explored that very question.

No devices need to be returned at this time. However, the FDA warned, using these heart pumps without reviewing the updated instructions could result in "serious injury or death.”