A Medical Device Daily

The Department of Health and Human Services reported its support of a new proposed regulation of Patient Safety Organizations (PSOs), a measure set to improve the quality of healthcare.

PSOs are private entities recognized by the HHS Secretary to collect and analyze patient safety events reported by healthcare providers. They are new and separate from all currently existing entities addressing healthcare quality.

The creation of PSOs has been called for by the Institute of Medicine (IOM; Washington) to improve the quality and safety of healthcare in several ways. PSOs would allow the voluntary reporting of patient safety events without fear of tort liability. In addition, they are intended to encourage clinicians and healthcare organizations to voluntarily share data on patient safety events more freely and consistently.

Under the proposal, PSOs can collect, aggregate and analyze data and provide feedback to help clinicians and healthcare organizations improve health care quality.

PSOs “will help make healthcare safer for all Americans,” HHS Secretary Mike Leavitt said. “By making it easier for patient safety events to be reported and the lessons learned from them to be shared more broadly, patients will ultimately receive safer healthcare.”

The authority to list, or formally recognize, PSOs was established by the Patient Safety and Quality Improvement Act of 2005. While the statute makes patient safety event reporting privileged and confidential, it does not relieve clinicians or health care organizations from meeting reporting requirements under federal, state or local laws. However, the statute and the proposed regulation address an important barrier that currently exists — the fear of legal liability or sanctions that can result from discussing and analyzing patient safety events.

The proposed regulation describes how an organization may become a PSO and explains how clinicians will be able to report patient safety events confidentially, the limited ways in which these data will be shared with others engaging in patient safety work while remaining privileged and confidential and how clinicians will receive feedback on ways to improve patient safety. Strong confidentiality provisions are the key to voluntary reporting, and breaches of these confidentiality provisions may result in the imposition of civil monetary penalties.

HHS’ Agency for Healthcare Research and Quality will administer the rules for listing qualified PSOs. The HHS Office for Civil Rights (OCR) will be responsible for enforcing the confidentiality provisions of the act. In addition, the department plans to issue guidance soon that would allow entities to be listed as PSOs, consistent with the statute, prior to publication of the final rule.

After collecting and analyzing sufficient non-identifiable data, AHRQ will publish information on national and regional statistics, including trends and patterns of patient safety events. This information will be published in AHRQ’s annual National Healthcare Quality Report.

Members of the public are invited to comment on the proposed regulation until April 14, with their feedback used to shape the final regulation. In addition, AHRQ and OCR are planning to host an audio conference on Feb. 29, 2 p.m.-3 p.m., EST, to provide details and answer questions about the regulations.

PTO objects to senate patent reform bill

The Bush administration in a six-page “views” letter to Sen. Patrick J. Leahy, chairman of the Senate Judiciary Committee, outlined its objections to a patent reform bill awaiting Senate approval. At issue is Section 4 of the bill, known as S. 1145, which addresses the right of the inventor to obtain damages.

“The requirements in Section 4 of the bill, as currently drafted, would likely lead to less than adequate compensation for many patent holders and could promote infringement,” argued Nathaniel Wienecke, assistant secretary for legislative and intergovernmental affairs for the Department of Commerce. “The administration does not believe it advisable to create a statutory directive to courts that requires them to rigidly apply, in all cases, only one of the several broadly accepted factors now evaluated by the courts,” he wrote in the Bush administration’s letter to Leahy.

Unless Section 4 is significantly revised, Wienecke insisted, “the resulting harm to a reasonably well-functioning U.S. intellectual property system would outweigh all the bill’s useful reforms.”

He said the administration supports legislation to improve the patent system, but that the current version of S. 1145 “does not do that,” said Jon Dudas, under secretary of commerce for intellectual property at the U.S. Patent and Trademark Office. “In some ways, it undermines innovation, particularly in the damages provision,” he asserted during a Feb. 5 briefing.

The patent reform bill, which was passed by the House in a 220-175 vote in September, threatens the existence of biotech firms, universities and small inventors, Dudas said.

Section 4 of S. 1145 limits the discretion of the federal courts in determining how damages are calculated to compensate a patent holder for patent infringement, Wienecke explained.

“The administration believes that such a dramatic change from current jurisprudence may have the unintended consequence of reducing the rewards of innovation and encouraging patent infringement,” he said. “The U.S. patent system must preserve the incentive to innovate and continue to offer innovators the opportunity to be adequately compensated and recover their investments.”