Architecture of a consent management suite and integration into IHE-based regional health information networks

<p>Abstract</p> <p>Background</p> <p>The University Hospital Heidelberg is implementing a Regional Health Information Network (RHIN) in the Rhine-Neckar-Region in order to establish a shared-care environment, which is based on established Health IT standards and in particular Integrating the Healthcare Enterprise (IHE). Similar to all other Electronic Health Record (EHR) and Personal Health Record (PHR) approaches the chosen Personal Electronic Health Record (PEHR) architecture relies on the patient's consent in order to share documents and medical data with other care delivery organizations, with the additional requirement that the German legislation explicitly demands a patients' opt-in and does not allow opt-out solutions. This creates two issues: firstly the current IHE consent profile does not address this approach properly and secondly none of the employed intra- and inter-institutional information systems, like almost all systems on the market, offers consent management solutions at all. Hence, the objective of our work is to develop and introduce an extensible architecture for creating, managing and querying patient consents in an IHE-based environment.</p> <p>Methods</p> <p>Based on the features offered by the IHE profile Basic Patient Privacy Consent (BPPC) and literature, the functionalities and components to meet the requirements of a centralized opt-in consent management solution compliant with German legislation have been analyzed. Two services have been developed and integrated into the Heidelberg PEHR.</p> <p>Results</p> <p>The standard-based Consent Management Suite consists of two services. The Consent Management Service is able to receive and store consent documents. It can receive queries concerning a dedicated patient consent, process it and return an answer. It represents a centralized policy enforcement point. The Consent Creator Service allows patients to create their consents electronically. Interfaces to a Master Patient Index (MPI) and a provider index allow to dynamically generate XACML-based policies which are stored in a CDA document to be transferred to the first service. Three workflows have to be considered to integrate the suite into the PEHR: recording the consent, publishing documents and viewing documents.</p> <p>Conclusions</p> <p>Our approach solves the consent issue when using IHE profiles for regional health information networks. It is highly interoperable due to the use of international standards and can hence be used in any other region to leverage consent issues and substantially promote the use of IHE for regional health information networks in general.</p

Elevated periimplantation uterine natural killer cell density in human endometrium is associated with impaired corticosteroid signaling in decidualizing stromal cells

Background: Decidualizing human endometrial stromal cells (HESCs) profoundly up-regulate 11β-hydroxysteroid dehydrogenase type 1 (11βHSD1), the enzyme that converts inert cortisone to active cortisol. We postulated that the induction of a cortisol gradient upon decidualization of the periimplantation endometrium may impact on the uterine natural killer (uNK) cell population and on local expression of corticosteroid-dependent target genes. Methods: Midluteal endometrial biopsies (n = 55) were processed for uNK cell (CD56) analysis and primary HESC cultures. The cultures remained either untreated or were decidualized for 4 or 8 days. A tissue microarray was constructed from endometria with normal (n = 18) and elevated uNK cell (n = 18) scores. An abnormal uNK cell test was defined as greater than 5% CD56+ cells in the subluminal stroma. Results: Increased uNK cell density was associated with lower endometrial expression of 11βHSD1 and mineralocorticoid receptor (MR) but not glucocorticoid receptor in vivo. Elevated uNK cell density also corresponded to impaired induction of key decidual markers (11βHSD1, prolactin, and insulin-like growth factor binding protein-1) and MR-dependent enzymes (dehydrogenase/reductase member 3 and retinol saturase) in differentiating HESC cultures. Increased uNK cell density in vivo was not associated with increased in vitro expression of either IL-15 or IL-11, two cytokines implicated in uNK cell regulation. Conclusions: Elevated levels of uNK cells in the stroma underlying the surface epithelium are associated with inadequate cortisol biosynthesis by resident decidualizing cells and suboptimal induction of key MR-dependent enzymes involved in lipid biogenesis and the retinoid transport pathway. Our observations suggest that uNK cell testing identifies those women at risk of reproductive failure due to relative uterine cortisol deficiency

Identity Management to Support Access Control in E-Health Systems

The related and often challenging topics of identity management and access control form an essential foundation for e-health infrastructure. Several approaches and supporting specifications for electronic healthcare record system (EHR-S) communication have been proposed by research projects and standards development organizations in recent years. For instance, part four of the CEN TC251 EN13606 EHRcom standard and the HL7 Role Based Access Control Draft Standard for Trial Use have helped to specify the nature of access control behaviour in relation to EHR communication within and between healthcare organisations. Access control services are a core component not only of the integrated care EHR-S but also for other information systems in the e-health domain. To underpin functionality of this type in a distributed environment, it is necessary to provide access to scalable, secure and uniform ID domains for users and patients. This paper considers the use of part four of the EHRcom standard in the context of the availability (or lack thereof) of national identification systems for patients and for users of an integrated care EHR-S. This work begins with a brief summary of the state-of-the-art in identity management and access control in the health domain and a description of approaches that could lead to a secure and interoperable identification mechanism. To address the identification problem, the authors describe well known EHR access control viewpoints that are compatible with the CEN standard for EHR communication, EN13606 and describe how an identification service can support this functionality

Hospitals and Social Care in the Early Modern Period. The Realisation and Discussion of the Welfare State in Italy

Il saggio, contenuto nel volume Hospitals and Social Care in the Early Modern Period. The Realisation and Discussion of the Welfare State in Italy, in Europ\ue4isches Spitalwesen. Institunionelle F\ufcrsorge in Mittelalter und Fr\ufcher Neuzeit \u2013 Hospitals and Insitutional Care in Medieval and Early Modern Europe, a cura di Martin Scheutz, Andrea Sommerlechner, Herwig Weigl, Alfred Stefan Wei f, Wien-M\ufcnchen, R. Oldenbourg Verlag, 2008, s\u2019inserisce nel quadro di una ricerca di lungo periodo sugli ospedali e le istituzioni sociali in Europa. Alla luce di un\u2019ampia trattatistica che va dal tardo Seicento al primo Ottocento, esso s\u2019interroga sulla natura di un\u2019inedita e grande trasformazione che interessa le istituzioni sociali nella prima fase della modernizzazione e che vede anche in molti Stati italiani, gi\ue0 nel corso del Settecento, l\u2019ingresso di un nuovo soggetto nel campo della sanit\ue0 e dell\u2019assistenza, lo Stato. Esso riesce infatti a coniugare l\u2019idea di \u201cpolizia\u201d \u2013 tipica di una concezione dello Stato ormai interventista e tesa alla ricerca di un vasto controllo sociale, sotto l\u2019influenza del cameralismo \u2013 con quella di una \u201cfilantropia\u201d in grado di umanizzare un potere di tipo nuovo, non pi\uf9 fondato su basi religiose. In questo senso l\u2019assistenza non \ue8 pi\uf9 uno dei compiti del principe cristiano \u2013 come nelle realizzazioni d\u2019ispirazione gesuitica nella Roma innocenziana del tardo Seicento \u2013 o l\u2019opera dei corpi sociali autoorganizzati dell\u2019antico regime, ma si lega a un\u2019inedita visione della polis, di cui il sovrano diviene interprete. Ed \ue8 la distanza che ancora separa la \u201ccarit\ue0 cristiana\u201d di Muratori \u2013 con tutte le sue istanze di rinnovamento che trovano eco in molteplici proposte, ma pure con la sua fedelt\ue0 alla tradizione \u2013 dalla \u201ccarit\ue0 sociale\u201d quale fonte dello \u201cStato di benessere\u201d caratteristica di visioni successive, aprendo la strada agli interventi legislativi che dal secondo Settecento giungono al secolo successivo. Le misure pi\uf9 incisive si registrano, non a caso, l\ue0 dove l\u2019assolutismo aveva assunto i tratti pi\uf9 \u201cilluminati\u201d, in relazione sia ad avvicendamenti dinastici o a influssi d\u2019oltralpe, sia a sollecitazioni provenienti dal pensiero giuridico, rivolto a mettere in discussione le prerogative ecclesiastiche sulle opere pie. La Lombardia austriaca rappresenta, da questo punto di vista, un laboratorio esemplare \u2013 fra le riforme teresiane e i pi\uf9 radicali interventi giuseppini, incentrati sul controllo dei patrimoni e la nomina pubblica degli amministratori ormai sottratta ai patriziati cittadini \u2013 che avrebbero costituito la premessa della legislazione napoleonica e di quella della Restaurazione. Su questa base gli ospedali sono in grado di accogliere la clinica medica e chirurgica, che avrebbe aperto la strada al superamento del ricovero indifferenziato e soprattutto ai progressi scientifici e terapeutici dell\u2019Ottocento, mentre gli istituti assistenziali possono a loro volta mettere in primo piano una dimensione nuova, pedagogica, rieducativa, di accoglienza in qualche modo specializzata nei confronti della popolazione anziana. Eppure le istituzioni ospedaliere e assistenziali dell\u2019ancien r\ue9gime, tutt\u2019altro che immobili, rimangono alla base del nuovo sistema, in un articolato rapporto con la societ\ue0 civile e religiosa. Sono elementi di cui la modernizzazione settecentesca e del primo Ottocento, in particolare nei paesi asburgici, ha un\u2019attenta considerazione e che contribuiscono a mantenere i \u201cluoghi\u201d della cura e dell\u2019accoglienza al centro della vita delle citt\ue0 e dei territori