Reconciling the biomedical data commons and the GDPR: three lessons from the EUCAN ELSI collaboratory.

The coming-into-force of the EU General Data Protection Regulation (GDPR) is a watershed moment in the legal recognition of enforceable rights to informational self-determination. The rapid evolution of legal requirements applicable to data use, however, has the potential to outstrip the capabilities of networks of biomedical data users to respond to the shifting norms. It can also delegitimate established institutional bodies that are responsible for assessing and authorising the downstream use of data, including research ethics committees and institutional data custodians. These burdens are especially pronounced for clinical and research networks that are of transnational scale, because the legal compliance burden for outbound international data transfers from the EEA is especially high. Legislatures, courts, and regulators in the EU should therefore implement the following three legal changes. First, the responsibilities of particular actors in a data sharing network should be delimited through the contractual allocation of responsibilities between collaborators. Second, the use of data through secure data processing environments should not trigger the international transfer provisions of the GDPR. Third, the use of federated data analysis methodologies that do not provide analysis nodes or downstream users access to identifiable personal data as part of the outputs of those analyses should not be considered circumstances of joint controllership, nor lead to the users of non-identifiable data to be considered controllers or processors. These small clarifications of, or modifications to, the GDPR would facilitate the exchange of biomedical data amongst clinicians and researchers.

Advancing translational research with the Semantic Web.

BACKGROUND: A fundamental goal of the U.S. National Institute of Health (NIH) "Roadmap" is to strengthen Translational Research, defined as the movement of discoveries in basic research to application at the clinical level. A significant barrier to translational research is the lack of uniformly structured data across related biomedical domains. The Semantic Web is an extension of the current Web that enables navigation and meaningful use of digital resources by automatic processes. It is based on common formats that support aggregation and integration of data drawn from diverse sources. A variety of technologies have been built on this foundation that, together, support identifying, representing, and reasoning across a wide range of biomedical data. The Semantic Web Health Care and Life Sciences Interest Group (HCLSIG), set up within the framework of the World Wide Web Consortium, was launched to explore the application of these technologies in a variety of areas. Subgroups focus on making biomedical data available in RDF, working with biomedical ontologies, prototyping clinical decision support systems, working on drug safety and efficacy communication, and supporting disease researchers navigating and annotating the large amount of potentially relevant literature. RESULTS: We present a scenario that shows the value of the information environment the Semantic Web can support for aiding neuroscience researchers. We then report on several projects by members of the HCLSIG, in the process illustrating the range of Semantic Web technologies that have applications in areas of biomedicine. CONCLUSION: Semantic Web technologies present both promise and challenges. Current tools and standards are already adequate to implement components of the bench-to-bedside vision. On the other hand, these technologies are young. Gaps in standards and implementations still exist and adoption is limited by typical problems with early technology, such as the need for a critical mass of practitioners and installed base, and growing pains as the technology is scaled up. Still, the potential of interoperable knowledge sources for biomedicine, at the scale of the World Wide Web, merits continued work.

An ontological approach to evidence-based medicine and meta-analysis.

The "evidence-based medicine" (EBM) paradigm is centered on the concept of "best evidence" and clinical studies based on this approach are more likely to be considered by physicians in their practice. In this paper we describe an ontology representing the concepts involved in evidence-based medicine and meta-analysis and show how an ontological approach can be applied both for revisiting EBM conceptual foundations and for allowing a more effective knowledge-based information retrieval in literature.

Design of a standards-based external rules engine for decision support in a variety of application contexts: report of a feasibility study at Partners HealthCare System.

This project explored functional requirements for an institution-wide method, at Partners HealthCare, for interpreting clinical knowledge for decision support. Such knowledge is currently incorporated in a variety of clinical applications, yet the methods of representation and of execution vary and the ability to author/edit the rules by human experts is limited. We expanded on a 2002 "Knowledge Inventory" at Partners to evaluate feasibility of designing a single representation approach entailing: (a) exploration of specific needs of different applications, in terms of kinds of response required (synchronous/asynchronous, time criticality, etc.), context (e.g., implied patient, time frame, or episode), and kinds of actions to be triggered; (b) kind of representation of knowledge and feasibility of casting knowledge in the form of if em leader then statements; and (c) data and knowledge resources used (implied data model, and particular knowledge sources and terminology sources). The result of analysis was to design an architecture to accomplish this goal. We also did preliminary analysis of requirements for authoring for such a representation, and for implementation.

Endovascular management of acute carotid artery dissection with a waxing and waning neurological deficit.

PURPOSE: To evaluate the feasibility and efficacy of emergent carotid stenting for an acute internal carotid artery (ICA) dissection. CASE REPORT: A 51-year-old man was admitted to our emergency department's stroke unit 1 hour after the onset of left hemiparesis. Computed tomographic and transcranial Doppler scans showed no pathological findings, but the color Doppler study detected a double lumen in the right carotid bifurcation extending to the proximal ICA. Within the first 2 hours after admission, the patient's neurological status began to fluctuate; the NIH Stroke Scale (NIHSS) and Rankin scores evaluated each hour after admission ranged from 0 to 12 and from 0 to 3, respectively. Emergency carotid angiography confirmed the dissection of the bulb and proximal right ICA, which prompted implantation of 2 Wallstents from the internal to common carotid artery. Forty-eight hours later, the patient was almost totally asymptomatic with an NIHSS score of 1 and a Rankin score of 0; he was discharged on postoperative day 3. At 3 months, the patient was free of neurological symptoms and the stented carotid artery was patent. CONCLUSIONS: In patients with fluctuating neurological signs and symptoms consistent with carotid artery dissection that are refractory to medical therapy, a stent can be placed to prevent permanent neurological deficits provided that the anatomical conditions are suitable.

Endovascular graft infection: preliminary results of an international enquiry.

PURPOSE: To investigate the frequency of aortoiliac endovascular graft infections and seek the main factors influencing their development. METHODS: To augment personal experience (1 case), a questionnaire was sent to 40 international centers of vascular and endovascular surgery. The literature was also reviewed to collect data on infections developing in endovascular grafts. RESULTS: The survey (85% response rate) and literature review identified 62 cases of infected endovascular grafts (0.4% frequency of endograft infection). In 22 (35%) patients, the infection manifested initially with vague symptoms only, but 41 (65%) patients eventually presented with abdominal abscess, groin fistula, and septic embolization. Common bacteria, such as Staphylococcus aureus, were identified as the cause of most infections (54.5%). The majority (49, 79%) of the 62 patients were treated surgically; 11 (17.7%) patients received conservative therapy (no therapeutic data in 2 patients). Overall mortality was 27.4% (17/62), and operative mortality was 16.3% (8/49). Conservative treatment led to a mortality rate of 36.4% (4/11). The mean follow-up for all patients was 47.8 weeks. Possible factors influencing the development of an infection were secondary adjunctive procedures, immunosuppression, treatment of false aneurysms, and infected central lines. CONCLUSIONS: Infected endovascular grafts are an urgent problem that has been heretofore underestimated and will probably increase as follow-up lengthens. New techniques should be sought to expedite the diagnosis, and an international registry should be set up to provide validated data.