This policy brief summarizes current U.S. regulatory considerations for ensuring patient safety and health care quality of genetic/genomic test information for precision medicine in the era of artificial intelligence/machine learning (AI/ML). The critical role of innovative and efficient laboratory developed tests (LDTs) in providing accurate diagnostic genetic/genomic information for U.S. patient- and family-centered healthcare decision-making is significant. However, many LDTs are not fully vetted for sufficient analytic and clinical validity via current FDA and CMS regulatory oversight pathways. The U.S. Centers for Disease Control and Prevention\'s Policy Analytical Framework Tool was used to identify the issue, perform a high-level policy analysis, and develop overview recommendations for a bipartisan healthcare policy reform strategy acceptable to diverse precision and systems medicine stakeholders.

BACKGROUND: It is essential that electronic data collection (EDC) systems are both compliant with regulations and the principles of Good Clinical Practice (GCP) to allow for the timely and accurate reporting of data including safety data. For clinical trials of investigational medicinal products (CTIMPs), investigators must immediately report to the sponsor any serious adverse event (SAE) that occurs in a site for which they are responsible. It is therefore expected that sponsors provide systems for timely review and reporting should a SAE be classified as a suspected unexpected serious adverse reaction (SUSAR). Challenges arise when data related to adverse events (AEs) needs to be re-entered for SAEs; this can be prone to error and may delay reporting. Additionally, recognising what has changed from an initial SAE report when an investigator responds to queries raised can cause errors.
METHODS: A multi-disciplinary working group came together from a UK academic clinical trials unit (CTU) to establish if an electronic system could be created in the unit\'s open-source EDC system-REDCap, to manage SAEs in an efficient way.
RESULTS: A module has been created in REDCap to facilitate electronic SAE reporting: enabling an AE form to automatically trigger an SAE form for any AE which is also a SAE, prepopulating relevant fields of the SAE form, reducing the risk of delay and error when entering data into the SAE form. The system has also been developed with an embedded code to allow for instant visual recognition of any data updated following reporting to allow the sponsor to immediately review and resolve SAEs in a timely manner, complying with UK regulatory reporting. This functionality \'The eSAE Project\' is now an active project for all of our new trials where data collection is undertaken using the REDCap system.
CONCLUSIONS: The eSAE Project coded into REDCap offers a unique way of populating SAE forms with information already entered in the initial AE forms as applicable, coupled with highlighting any updates during the lifetime of the SAE for sponsors to identify any new information that needs to be reassessed to process and report the SAE.

Despite incineration is an important emission source of toxic pollutants, such as heavy metals and polychlorinated dibenzo-p-dioxins and dibenzofurans (PCDD/Fs), it is still one of the most widely used methods for the management of municipal solid waste. The current paper summarizes the results of a 20-year follow-up study of the emissions of PCDD/Fs by a municipal solid waste incinerator (MSWI) in Sant Adrià de Besòs (Catalonia, Spain). Samples of ambient air, soils and herbage were periodically collected near the facility and the content of PCDD/Fs was analyzed. In the last (2017) survey, mean levels in soil were 3.60 ng WHO-TEQ/kg (range: 0.40-10.6), being considerably higher than the mean concentrations of PCDD/Fs in soil samples collected near other MSWIs in Catalonia. Moreover, air PCDD/F concentrations were even higher than those found in a previous (2014) survey, as they increased from 0.026 to 0.044 pg WHO-TEQ/m3. Ultimately, the PCDD/F exposure would be associated to a cancer risk (2.5 × 10-6) for the population living in the surrounding area. Globally, this information indicates that the MSWI of Sant Adrià de Besòs could have had a negative impact on the environment and potentially on public health, being an example of a possible inappropriate management for years. The application of Best Available Techniques to minimize the emission of PCDD/Fs and other chemicals is critical.

The provision of dental sleep medicine (DSM) has caused the rapid growth and expansion of an industry that includes health care providers, manufacturers, and retailers. Sleep is used as a vital sign by health care providers to screen and test for sleep disorders and to prevent future health issues, disease, and catastrophic events. Professional services and devices continue to be developed to enhance and foster better sleep hygiene and environment and to encourage improved sleep by building a comprehensive portfolio of sleep solutions, including DSM. However, the provision of DSM requires compliance with applicable state and federal regulations.

UNASSIGNED: The open-source software offered by the Observational Health Data Science and Informatics (OHDSI) collective, including the OMOP-CDM, serves as a major backbone for many real-world evidence networks and distributed health data analytics platforms. While container technology has significantly simplified deployments from a technical perspective, regulatory compliance can remain a major hurdle for the setup and operation of such platforms. In this paper, we present OHDSI-Compliance, a comprehensive set of document templates designed to streamline the data protection and information security-related documentation and coordination efforts required to establish OHDSI installations.
UNASSIGNED: To decide on a set of relevant document templates, we first analyzed the legal requirements and associated guidelines with a focus on the General Data Protection Regulation (GDPR). Moreover, we analyzed the software architecture of a typical OHDSI stack and related its components to the different general types of concepts and documentation identified. Then, we created those documents for a prototypical OHDSI installation, based on the so-called Broadsea package, following relevant guidelines from Germany. Finally, we generalized the documents by introducing placeholders and options at places where individual institution-specific content will be needed.
UNASSIGNED: We present four documents: (1) a record of processing activities, (2) an information security concept, (3) an authorization concept, as well as (4) an operational concept covering the technical details of maintaining the stack. The documents are publicly available under a permissive license.
UNASSIGNED: To the best of our knowledge, there are no other publicly available sets of documents designed to simplify the compliance process for OHDSI deployments. While our documents provide a comprehensive starting point, local specifics need to be added, and, due to the heterogeneity of legal requirements in different countries, further adoptions might be necessary.

Using a narrative approach, this paper aims to determine the extent of Australian radiographers\' regulatory compliance to improve patient safety when performing appendicular X-ray and non-contrast brain computed tomography (CT) in the Emergency Department (ED).
A narrative review explored relevant literature and key regulatory policy. Ten documents were identified, three main themes were developed related to the radiographer roles in X-ray request justification, dose optimisation and preliminary image evaluation (PIE). Radiographers were equally aware of justification and optimisation pre and post the introduction of a Medical Code of Practice. The collective PIE accuracy of radiographers remained unaffected by changes in mode of PIE delivery and regulatory factors but varied based on the anatomical region.
While current Australian regulations mandate radiographer request justification, dose optimisation and PIE, the degree of compliance by Australian radiographers remains uncertain. Current literature provides evidence that radiographers can improve patient care and safety through justification, optimisation, and PIE delivery. Change in workplace practice, supported by key stakeholders including radiologists, is essential to integrate radiographers\' functions into routine ED clinical practice. Further research is required to audit radiographers\' regulatory compliance to improve patient safety.
Patient safety in ED can be improved with timely and accurate diagnosis provided by radiographers. Radiographers have a professional obligation to adhere to the capabilities and standards for safe medical radiation practice defined by Australian regulations. Therefore, radiographers must justify the X-ray request, optimise the radiation dose where appropriate and communicate urgent or unexpected findings to the referrer.

Physical contaminants in food, such as glass, metal, and plastic, can cause significant health risks and economic loss. This study explores these understudied physical hazards, aiming to provide comprehensive risk analysis and preventive solutions. Our research identified several key infiltration points in the food supply chain, including raw material sourcing and packaging stages. These hazards can be effectively mitigated by employing advanced technologies like metal detectors and optical sorting machines, along with stringent quality control measures. The findings offer valuable insights for stakeholders in the food industry, emphasizing the need for regulatory compliance and consumer education to ensure food safety.

In this study, direct analysis in real time high resolution mass spectrometry (DART-HRMS) was used to investigate the accurate characterisation of feed additive formulations containing coccidiostats or carotenoids. The study demonstrates the efficacy of DART-HRMS in identifying the active substances in these formulations and distinguishing between feed additives with the same active substance. The protocol for this method involves two simple steps that are extracting samples with organic solvents and measuring the extracts with DART-HRMS. The study also employs various statistical tools, including a factorial design approach, to optimise the DART-HRMS settings, and multivariate statistics, to establish classification models for feed additive formulations using nominal mass spectra. Our study demonstrates the potential of DART-HRMS in ensuring the correct identification of feed additives containing various coccidiostats or carotenoids and proposes this tool as an additional means for compliance checks with EU regulations.

Challenges with monitoring and detecting drug diversion in healthcare facilities continue to be a trending topic amid the opioid epidemic. This article aims to provide insight into the expansion of an academic medical center\'s drug diversion and controlled substances compliance program. The justification and structure of a multihospital, centralized program are discussed.
Establishing dedicated controlled substances compliance and drug diversion resources has become increasingly common as awareness of the widespread healthcare impact has grown. One academic medical center recognized the value in expanding from 2 dedicated full-time equivalents (FTEs) with a scope of one facility to multiple FTEs with a scope of 5 facilities. The expansion included considering current practices at each facility, establishing the centralized team\'s scope, gaining organizational support, recruiting a diverse team, and forming an effective committee structure.
There are multiple organizational benefits from establishing a centralized controlled substances compliance and drug diversion program, including standardization of processes, associated efficiencies, and effective risk mitigation by identifying inconsistent practices across the multifacility organization.

Emerging lead halide perovskite (LHP) photovoltaics are undergoing intense research and development due to their outstanding efficiency and potential for low manufacturing costs that render them competitive with existing photovoltaic (PV) technologies. While today\'s efforts are focused on stability and scalability of LHPs, the toxicity of lead (Pb) remains a major challenge to their large-scale commercialization. Here, we present a screening-level, EPA-compliant model of fate and transport of Pb leachate in groundwater, soil, and air, following hypothetical catastrophic breakage of LHP PV modules in conceptual utility-scale sites. We estimated exposure point concentrations of Pb in each medium and found that most of the Pb is sequestered in soil. Exposure point concentrations of Pb from the perovskite film fell well below EPA maximum permissible limits in groundwater and air even upon catastrophic release from PV modules at large scales. Background Pb levels in soil can influence soil regulatory compliance, but the highest observed concentrations of perovskite-derived Pb would not exceed EPA limits under our assumptions. Nonetheless, regulatory limits are not definitive thresholds of safety, and the potential for increased bioavailability of perovskite-derived Pb may warrant additional toxicity assessment to further characterize public health risks.