Assessment of the EU Member States' rules on health data in the light of GDPR

In the context of the Single Framework Contract Chafea/2018/Health/03 between the EUHealthSupport Consortium and the Consumers, Health and Food Executive Agency (Chafea), a study was conducted with the objective to examine and present the EU Member States’ rules governing the processing of health data in light of the GDPR, with the objective of highlighting possible differences and identifying elements that might affect the cross-border exchange of health data in the EU, and examining the potential for EU level action to support health data use and re-use. We distinguish between using health data for primary purposes (for treatment of the patient) and secondary purposes (for research, registries and management of the healthcare system). The study provides an evidence-based comparison of the state of play regarding health data governance within the EU. This will help to assess in what areas EU intervention might be needed and if so, through which types of measures, be it measures such as a Code of Conduct for data processing in the health area, which could be supported by an EU level implementing act or more direct legislative action, taking into account the particularities of the health systems in the Member States. The study uses a mixed-methods approach, consisting of the following elements: - Literature review to provide an overview of best practices, bottlenecks, policy options and possible solutions already identified in the literature. - Mapping legal and technical aspects of health data usage at national level to provide an overview of the differences among countries in legislation, regulation and governance models regarding processing health data. - In-depth case studies of national governance models for health data sharing. - Workshops held with MoH representatives, experts, stakeholder representatives and experts from national data protection offices. - Stakeholder Survey to cross validate and supplement the topics addressed and identified in the Member State legal and technical aspects mapping. The results of this study allow for a detailed assessment of possible elements at Member States/EU level that might affect the movement of health data across borders. It also identifies practices that could facilitate this exchange of data, as well as possible policy options for strategies in this area. Finally, we explored possibilities for sustainable governance structures for health data collection, processing and transfer, as well as measures empowering citizens to have more control of their own health data and to ensure portability and interoperability of these data

Dilemmas for the pathologist in the oncologic assessment of pancreatoduodenectomy specimens

A pancreatoduodenectomy specimen is complex, and there is much debate on how it is best approached by the pathologist. In this review, we provide an overview of topics relevant for current clinical practice in terms of gross dissection, and macro- and microscopic assessment of the pancreatoduodenectomy specimen with a suspicion of suspected pancreatic cancer. Tumor origin, tumor size, degree of differentiation, lymph node status, and resection margin status are universally accepted as prognostic for survival. However, different guidelines diverge on important issues, such as the diagnostic criteria for evaluating the completeness of resection. The macroscopic assessment of the site of origin in periampullary tumors and cystic lesions is influenced by the grossing method. Bi-sectioning of the head of the pancreas may offer an advantage in this respect, as this method allows for optimal visualization of the periampullary area. However, a head-to-head comparison of the assessment of clinically relevant parameters, using axial slicing versus bi-sectioning, is not available yet and the gold standard to compare both techniques prospectively might be subject of debate. Further studies are required to validate the various dissection protocols used for pancreatoduodenectomy specimens and their specific value in the assessment of pathological parameters relevant for prognosis

Axial slicing versus bivalving in the pathological examination of pancreatoduodenectomy specimens (APOLLO): a multicentre randomized controlled trial

Background: In pancreatoduodenectomy specimens, dissection method may affect the assessment of primary tumour origin (i.e. pancreatic, distal bile duct or ampullary adenocarcinoma), which is primarily determined macroscopically. This is the first study to prospectively compare the two commonly used techniques, i.e. axial slicing and bivalving. Methods: In four centres, a randomized controlled trial was performed in specimens of patients with a suspected (pre)malignant tumour in the pancreatic head. Primary outcome measure was the level of certainty (scale 0–100) regarding tumour origin by four independent gastrointestinal pathologists based on macroscopic assessment. Secondary outcomes were inter-observer agreement and R1 rate. Results: In total, 128 pancreatoduodenectomy specimens were randomized. The level of certainty in determining the primary tumour origin did not differ between axial slicing and bivalving (mean score 72 [sd 13] vs. 68 [sd 16], p = 0.21), nor did inter-observer agreement, both being moderate (kappa 0.45 vs. 0.47). In pancreatic cancer specimens, R1 rate (60% vs. 55%, p = 0.71) and the number of harvested lymph nodes (median 16 vs. 17, p = 0.58) were similar. Conclusion: This study demonstrated no differences in determining the tumour origin between axial slicing and bivalving. Both techniques performed similarly regarding inter-observer agreement, R1 rate, and lymph node harvest

Assessment of the EU Member States' rules on health data in the light of GDPR

In the context of the Single Framework Contract Chafea/2018/Health/03 between the EUHealthSupport Consortium and the Consumers, Health and Food Executive Agency (Chafea), a study was conducted with the objective to examine and present the EU Member States’ rules governing the processing of health data in light of the GDPR, with the objective of highlighting possible differences and identifying elements that might affect the cross-border exchange of health data in the EU, and examining the potential for EU level action to support health data use and re-use. We distinguish between using health data for primary purposes (for treatment of the patient) and secondary purposes (for research, registries and management of the healthcare system). The study provides an evidence-based comparison of the state of play regarding health data governance within the EU. This will help to assess in what areas EU intervention might be needed and if so, through which types of measures, be it measures such as a Code of Conduct for data processing in the health area, which could be supported by an EU level implementing act or more direct legislative action, taking into account the particularities of the health systems in the Member States. The study uses a mixed-methods approach, consisting of the following elements: - Literature review to provide an overview of best practices, bottlenecks, policy options and possible solutions already identified in the literature. - Mapping legal and technical aspects of health data usage at national level to provide an overview of the differences among countries in legislation, regulation and governance models regarding processing health data. - In-depth case studies of national governance models for health data sharing. - Workshops held with MoH representatives, experts, stakeholder representatives and experts from national data protection offices. - Stakeholder Survey to cross validate and supplement the topics addressed and identified in the Member State legal and technical aspects mapping. The results of this study allow for a detailed assessment of possible elements at Member States/EU level that might affect the movement of health data across borders. It also identifies practices that could facilitate this exchange of data, as well as possible policy options for strategies in this area. Finally, we explored possibilities for sustainable governance structures for health data collection, processing and transfer, as well as measures empowering citizens to have more control of their own health data and to ensure portability and interoperability of these data

Salt inactivation of classical swine fever virus and African swine fever virus in porcine intestines confirms the existing in vitro casings model

Natural casings, to be used as sausage containers, are being traded worldwide and may be contaminated with contagious viruses. Standard processing of such natural casings is by salt treatment with a duration of 30 days before shipment. Since information is lacking about the efficacy of these virus inactivation procedures, an in vitro 3D collagen matrix model, mimicking natural casings, was developed previously to determine the efficacy of salt to inactivate specific viruses. To validate this model, a comparison in vivo experiment was performed using intestines of pigs experimentally infected with African swine fever virus (ASFV) and classical swine fever virus (CSFV). Decimal reduction (D) values, were determined at 4 °C, 12 °C, 20 °C and 25 °C. The standard salt processing procedure showed an efficient inactivation of ASFV and CSFV over time in a temperature dependent way. Dintestine values of both viruses, treated with the standard salt treatment, were in line with the Dcollagen values. It was concluded that these results underline the suitability of the 3D collagen matrix model to determine virus inactivation and to replace animal experiments. Furthermore, an increase in storage time for standard salt processed casings derived from CSFV endemic regions is highly recommended for an efficient inactivation of CSFV.</p