Mapping clinical procedures to the ICD-10-PCS: The German operation and procedure classification system use case.

Mappings among terminologies to ensure homogeneous analysis among different data sources is one of the key challenges of semantic interoperability. Concretely, mappings to the International Classification of Diseases 10th Revision Procedure Classification System (ICD-10-PCS) are especially challenging due to its multiaxial structure and lack of terms used by physicians (many terminologies used in real world data (RWD) are initially intended for reimbursement, not for clinical purposes). In this work, we propose a new theoretical methodology for mapping healthcare data to the ICD-10-PCS by exploiting its multiaxial structure to reduce the search spaces within concepts and leveraging the dependencies between axes for inferring additional relevant information. We tested this methodology with a subset of the German Operation and Procedure Classification System (OPS), aiming to integrate heterogeneous data sources queried for clinical research.

An induction or flare of arthritis and/or sacroiliitis by vedolizumab in inflammatory bowel disease: a case series.

BACKGROUND: In inflammatory bowel disease (IBD), a new biological therapy has recently been approved. Vedolizumab is a humanised IgG1 monoclonal antibody to α4ß7 integrin that modulates gut lymphocyte trafficking. Although an exclusively local effect of vedolizumab could be expected based on the restricted presence of the α4ß7-mucosal vascular addressin cell adhesion molecule 1 complex in the gut, past combined success with anti-tumour necrosis factor, and previous demonstration of α4ß7 integrin in the joint, led to the expectation of a therapeutic efficacy in spondyloarthritis. Nonetheless, the effect of vedolizumab on extraintestinal manifestations-and especially the joint-has not been reported so far. CASE REPORT: A series of five patients with IBD who were treated with vedolizumab and promptly developed new onset or exacerbation of sacroiliitis or arthritis are reported. CONCLUSIONS: Vedolizumab therapy does not seem to show any efficacy in and might even induce arthritis and/or sacroiliitis. However, larger cohort studies are needed to provide information on the prevalence, the evolution and underlying mechanism.

Electronic health records: new opportunities for clinical research.

Clinical research is on the threshold of a new era in which electronic health records (EHRs) are gaining an important novel supporting role. Whilst EHRs used for routine clinical care have some limitations at present, as discussed in this review, new improved systems and emerging research infrastructures are being developed to ensure that EHRs can be used for secondary purposes such as clinical research, including the design and execution of clinical trials for new medicines. EHR systems should be able to exchange information through the use of recently published international standards for their interoperability and clinically validated information structures (such as archetypes and international health terminologies), to ensure consistent and more complete recording and sharing of data for various patient groups. Such systems will counteract the obstacles of differing clinical languages and styles of documentation as well as the recognized incompleteness of routine records. Here, we discuss some of the legal and ethical concerns of clinical research data reuse and technical security measures that can enable such research while protecting privacy. In the emerging research landscape, cooperation infrastructures are being built where research projects can utilize the availability of patient data from federated EHR systems from many different sites, as well as in international multilingual settings. Amongst several initiatives described, the EHR4CR project offers a promising method for clinical research. One of the first achievements of this project was the development of a protocol feasibility prototype which is used for finding patients eligible for clinical trials from multiple sources.

Towards a European health research and innovation cloud (HRIC).

The European Union (EU) initiative on the Digital Transformation of Health and Care (Digicare) aims to provide the conditions necessary for building a secure, flexible, and decentralized digital health infrastructure. Creating a European Health Research and Innovation Cloud (HRIC) within this environment should enable data sharing and analysis for health research across the EU, in compliance with data protection legislation while preserving the full trust of the participants. Such a HRIC should learn from and build on existing data infrastructures, integrate best practices, and focus on the concrete needs of the community in terms of technologies, governance, management, regulation, and ethics requirements. Here, we describe the vision and expected benefits of digital data sharing in health research activities and present a roadmap that fosters the opportunities while answering the challenges of implementing a HRIC. For this, we put forward five specific recommendations and action points to ensure that a European HRIC: i) is built on established standards and guidelines, providing cloud technologies through an open and decentralized infrastructure; ii) is developed and certified to the highest standards of interoperability and data security that can be trusted by all stakeholders; iii) is supported by a robust ethical and legal framework that is compliant with the EU General Data Protection Regulation (GDPR); iv) establishes a proper environment for the training of new generations of data and medical scientists; and v) stimulates research and innovation in transnational collaborations through public and private initiatives and partnerships funded by the EU through Horizon 2020 and Horizon Europe.

ICD-10-CM extension with ICD-9 diagnosis codes to support integrated access to clinical legacy data.

INTRODUCTION: ICD is currently the most widely used terminology to code diagnosis and procedures. The transition from ICD-9-CM to ICD-10-CM became effective on October 1, 2015 in US and many other countries. Projects that use this codification for research purposes, requires advanced methods to exploit data with both versions of ICD. Although the General Equivalence Mappings (GEMs), provided by the Centers for Medicare and Medicaid Services, might help to overcome these challenges, their direct use as translation mappings is not possible, mostly due to the further specificity of ICD-10-CM concepts. OBJECTIVE: We propose a methodology to generate an extended version of ICD-10-CM with selected ICD-9-CM diagnosis codes. METHODS: The extension was generated using the GEMs relations between concepts of both terminologies and the hierarchical relations of ICD-10-CM. RESULTS: This extended ICD-10-CM, together with modifications to the mapping of ICD-9-CM concepts that were not inserted, allows the generation of an improved translation of legacy data, raising the number of 1-to-1 correspondences by +13.81%. CONCLUSION: The extended ICD-10-CM enables the accurate integration of ICD-9-CM and ICD-10-CM diagnosis data into a single terminology. With such analysis of data possible without having to specify both ICD-9-CM and ICD-10-CM separately for each query.

ICD-10-PCS extension with ICD-9 procedure codes to support integrated access to clinical legacy data.

Since the creation of The International Classification of Diseases (ICD), new versions have been released to keep updated with the current medical knowledge. Migrations of Electronic Health Records (EHR) from ICD-9 to ICD-10-PCS as clinical procedure codification system, has been a significant challenge and involved large resources. In addition, it created new barriers for integrated access to legacy medical procedure data (frequently ICD-9 coded) with current data (frequently ICD-10-PCS coded). This work proposes a solution based on extending ICD-10-PCS with a subgroup of ICD-9-CM concepts to facilitate such integrated access. The General Equivalence Mappings (GEMs) has been used as foundation to set the terminology relations of these inserted concepts in ICD-10-PCS hierarchy, but due to the existence of 1-to-many mappings, advanced rules are required to seamlessly integrate both terminologies. With the generation of rules based on GEMs relationships, 2014 ICD-9 concepts were included within the ICD-10-PCS hierarchy. For the rest of the concepts, a new method is also proposed to increase 1-to-1 mappings. As results, with the suggested approach, the percentage of ICD-9-CM procedure concepts that can be mapped accurately (avoiding mappings to a large number of concepts) rise from 11.56% to 69.01% of ICD-9-Proc, through the extended ICD-10-PCS hierarchy.

Privacy protection for HealthGrid applications.

OBJECTIVES: This contribution aims at introducing the problem of privacy protection in e-Health and at describing a number of existing privacy enhancing techniques (PETs). The recognition that privacy constitutes a fundamental right is gradually entering public awareness. Because healthcare-related data are susceptible to being abused for many obvious reasons, public apprehension about privacy has focused on medical data. Public authorities have become convinced of the need to enforce privacy protection and make considerable efforts for promoting through privacy protection legislation the deployment of PETs. METHODS: Based on the study of the specific features of Grid technology, ways in which PET services could be integrated in the HealthGrid are being analyzed. Grid technology aims at removing barriers between local and remote resources. The privacy and legal issues raised by the HealthGrid are caused by the transparent interchange and processing of sensitive medical information. PET technology has already proven its usefulness for privacy protection in health-related marketing and research data collection. RESULTS: While this paper does not describe market-ready solutions for privacy protection in the HealthGrid, it puts forward several cases in which the Grid may benefit from PETs. CONCLUSION: Early integration of privacy protection services into the HealthGrid can lead to a synergy that is beneficial for the development of the HealthGrid itself.

Privacy protection for clinical and genomic data. The use of privacy-enhancing techniques in medicine.

Privacy includes the right of individuals and organisations to determine for themselves when, how and to what extent information about them is communicated to others. The growing need of managing large amounts of both clinical and genetic data raises important legal and ethical challenges. This paper introduces some of the privacy-protection problems related to classical and genomic medicine, and highlights the relevance of trusted third parties and of privacy-enhancing techniques (PETs) in the context of data collection, e.g., for research. Practical approaches based on two pseudonymisation models, for both batch data collection and interactive data storage, are presented. The actual application of the described techniques today proves the possible benefits for medicine that innovative privacy-enhancing techniques can provide. Technical PET solutions can unlock valuable data sources, otherwise not available.

The Healthgrid White Paper.

Over the last four years, a community of researchers working on Grid and High Performance Computing technologies started discussing the barriers and opportunities that grid technologies must face and exploit for the development of health-related applications. This interest lead to the first Healthgrid conference, held in Lyon, France, on January 16th-17th, 2003, with the focus of creating increased awareness about the possibilities and advantages linked to the deployment of grid technologies in health, ultimately targeting the creation of a European/international grid infrastructure for health. The topics of this conference converged with the position of the eHealth division of the European Commission, whose mandate from the Lisbon Meeting was "To develop an intelligent environment that enables ubiquitous management of citizens' health status, and to assist health professionals in coping with some major challenges, risk management and the integration into clinical practice of advances in health knowledge." In this context "Health" involves not only clinical procedures but covers the whole range of information from molecular level (genetic and proteomic information) over cells and tissues, to the individual and finally the population level (social healthcare). Grid technology offers the opportunity to create a common working backbone for all different members of this large "health family" and will hopefully lead to an increased awareness and interoperability among disciplines. The first HealthGrid conference led to the creation of the Healthgrid association, a non-profit research association legally incorporated in France but formed from the broad community of European researchers and institutions sharing expertise in health grids. After the second Healthgrid conference, held in Clermont-Ferrand on January 29th-30th, 2004, the need for a "white paper" on the current status and prospective of health grids was raised. Over fifty experts from different areas of grid technologies, eHealth applications and the medical world were invited to contribute to the preparation of this document.

Privacy enhancing techniques - the key to secure communication and management of clinical and genomic data.

OBJECTIVES: To introduce some of the privacy protection problems related to genomics based medicine and to highlight the relevance of Trusted Third Parties (TTPs) and of Privacy Enhancing Techniques (PETs) in the restricted context of clinical research and statistics. METHODS: Practical approaches based on two different pseudonymisation models, both for batch and interactive data collection and exchange, are described and analysed. RESULTS AND CONCLUSIONS: The growing need of managing both clinical and genetic data raises important legal and ethical challenges. Protecting human rights in the realm of privacy, while optimising research potential and other statistical activities is a challenge that can easily be overcome with the assistance of a trust service provider offering advanced privacy enabling/enhancing solutions. As such, the use of pseudonymisation and other innovative Privacy Enhancing Techniques can unlock valuable data sources.

The PRIDEH project: taking up privacy protection services in e-health.

PRIDEH (Privacy Enhancement in Data Management in e-Health) is a project that runs for two years and is partly funded by the European Commission. The focus of PRIDEH is on the stimulation of the take-up of privacy enhancing technologies within the health domain. Privacy enhancing technologies build upon available cryptographic and communication technologies. The concept of privacy enhancing services delivery through the use of intermediary trusted third parties has already been described in literature but rarely turned into practice. A number of limited PET (Privacy Enhancing Technologies) applications exist in closed domains. The very few existing solutions are not based on an independent TTP (Trusted Third Party) concept which renders their trustworthiness questionable. PRIDEH wants to enhance the take-up of PET delivery based on sound TTP principles in the domain of healthcare.

e-Health standardization in Europe: lessons learned.

Challenges regarding standardization in e-Health are analyzed, and solutions for ensuring their practical implementation are proposed. Emphasis is put on new mechanisms for enhancing the collaboration between the industry and standardization bodies.