The United States Consumer Product Safety Commission (CPSC) is requesting digital patient data from hospitals as part of its efforts to track consumer product-related injuries. By the end of the year, CPSC hopes that more than 100 hospitals will provide the requested records to the Kansas-based government contractor Konza Health, which was awarded a $15.9 million contract last year to support the National Electronic Injury Surveillance System (NEISS) Remodel project.

NEISS has been in operation for more than 5 decades, and its primary purpose is to collect data on consumer product-related injuries in the United States. NEISS is an important public health research tool; however, data collection is labor-intensive and involves a manual review and coding of medical records from around 70 of the nation’s 5,000+ hospital emergency departments. Currently, 14 states do not have any participating hospitals, which limits the geographic reach of the system and has reduced CPSC’s ability to identify rare and emerging product hazards.

Under the planned NEISS Remodel (NEISS-R) project, coverage will be expanded to all 50 states to ensure data is collected from currently underrepresented and non-represented states. The plan involves automating data collection by leveraging modem technology and the country’s electronic health record infrastructure. In so doing, CPSC said it will be able to identify rare and emerging hazards much more rapidly than the legacy system allows.

NEISS-R will see data exchanged through a federally designated Qualified Health Information Network (QHIN), which CPSC claims “is supported by contractual privacy requirements and standardized security safeguards.” The data collected will be limited, as will data retention, to the minimum necessary information to support CPSC’s statutory mission, and will support de-identification before the data reaches CPSC. CPSC says the project will result in a more timely, more accurate, and more cost-effective system, which will better protect American families.

Under the current system, emergency department nurses are required to review patient charts, manually identify consumer-related accidents, and enter that information into a national database. Under the new system, data collection would be automated, and it would be the responsibility of Konza Health, a TEFCA QHIN, to strip out identifying information prior to data transfers to CPSC.

According to the letters sent by Konza Health to hospitals, “Using accident-related diagnosis codes, Konza Health will identify patients that may have experienced a consumer product-related accident. For identified accidents, Konza Health will gather additional patient clinical information and provide it to CPSC for follow-up.” The letters request meetings with the selected hospitals to establish connectivity methods to allow secure data exchange for the project.

The NEISS-R project has sparked privacy fears, as under the manual system, nurses were instructed not to provide identifiable information such as patient names, addresses, or birth dates; however, the automated system would involve sending identifiable patient data Konza Health. While it is claimed that the data provided to CPSC will be unchanged from the information it has obtained for the past five decades, far broader access to patient data is sought.

KFF Health News reports that, based on emails shared by hospitals and interviews with people involved or familiar with the discussions between the hospitals and Konza Health, the data requested falls well outside of the CPSC’s consumer product safety mission. “In a stark departure from its product-focused mission, the agency’s goal is to obtain millions of Americans’ medical records from emergency room visits for most injuries, from a broken bone to a childhood vaccine reaction or even a suicide attempt,” explained KFF Health News. “A CPSC official also insisted in the emails that the institutions provide all ER patients’ identifiable information — such as names, addresses, diagnoses, and other personal details — to the contractor, Konza Health, for analysis.” According to communications between Konza Health and technology officials at one hospital, ER data is requested for more than 10,000 conditions, including injuries totally unrelated to consumer products.

CPSC and Konza Health have faced resistance from some hospitals over the mandatory provision of the data, and have suggested that refusing to provide the required data could be viewed as information blocking, potentially leading to significant penalties; however, the information being sought raises HIPAA concerns. Under HIPAA, hospitals are permitted, but not required, to submit data to CPSC for public health purposes, but any disclosure should be limited to the minimum necessary information to achieve the purpose for the disclosure. Since CPSC is collecting data to fulfil its consumer product safety mission, any data disclosed should be limited to that purpose. Should CPSC require more data than it has previously collected, further rulemaking would be necessary.

Participating hospitals could find themselves between a rock and a hard place – potential fines for information blocking if they do not agree to provide the requested data and potential HIPAA fines if they do. However, under the current information blocking regulations, there is a privacy exception, the purpose of which is to ensure that health information is not required to be disclosed in a way that is prohibited under state or federal privacy laws, and under the HIPAA minimum necessary standard, disclosures should be restricted to information required for CPSC’s public health activities, which concern consumer product safety.

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