Projects

Health Law, Privacy & Ethics

Within Lygature, the team from the Health Law, Privacy & Ethics (HPE) portfolio has extensive experience on legal and ethical issues concerning data protection, health laws, research integrity, quality assurance, regulatory and healthcare.

Our services range from acting as a ‘think tank’ to hands-on practical advice with regards to data infrastructures and governance, Data Protection Impact Assessments (DPIA’s) and ethical aspects of data processing.

Our activities, either in consortia or as a stand-alone service, include drawing up data governance documents, data access agreements, DPIA’s, and ELSI aspects in consortium agreements. In addition, we carry out independent background studies on the responsible use of data on the interface between health care and a learning health care system, health regulations and quality. In that context, we support new and running consortia with advice and guidance on legal, ethical and privacy issues, both on a national and international level.

For our stand-alone service activities we mostly work for healthcare institutions, research institutes, scientific associations and (semi) governmental bodies and hospitals.

Amongst others, the HPE team is currently involved in the following projects: HEALTH-RI, HEAP, Trials@Home, IDEA Fast, Deliver, Prudent, Aboard

COREON

COREON (Committee on Regulation of Health Research) is an expert network of researchers that is committed to the balanced regulation of (observational) health research and an adequate application of those regulations.
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HEAP

The Human Exposome Assessment Platform
Goal: HEAP will provide an open access, technical research platform to assess the impact of the exposome on human health. It will contain high-quality exposome data from five different cohort studies, and will be scalable to any research setting.
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Trials@Home

A consortium exploring the opportunities of moving clinical trials from the traditional clinic setting to the participant's immediate surroundings.
Goal: To develop and test remote decentralised methods to streamline data collection, participant recruitment and retention.
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IDEA Fast

Identifying digital endpoints to assess fatigue, sleep and activities in daily living in neurdoegenerative disorders and immune-mediated inflammatory diseases.
Goal: IDEA-FAST aims to identify digital endpoints that provide reliable, objective and sensitive evaluation of activities of daily life, disability and health related-quality of life for selected neurodegenrative diseases.
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Deliver

The overall aim is to provide and implement a blueprint model for improving quality and safety of oral care for everyone: the DELIVER Quality Improvement Model. As highlighted in the 2021 WHO Oral Health Resolution, many EU citizens do not have access to quality oral care.
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Health-RI

A national health research infrastructure for optimal access to knowledge, tools, facilities, health data and samples.
Goal: To enable sustainable and affordable personalized medicine and health. HPE team members contribute their expertise to the ELSI Servicedesk.
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PRUDENT

Oral diseases and conditions are the 3rd most expensive diseases to treat in the EU. They affect about half of the EU population. As highlighted in the 2021 WHO Oral Health Resolution, there are major challenges in the financing of oral health care: in deviation from the UN and WHO goal of Universal Health Coverage, many EU citizens do not have access to essential oral health care without financial hardship. This causes detrimental impacts for the individual citizen, while increasing costs and wasting resources on the macro level. Research-policy gaps and research-practice gaps keep triggering inertia and inaction instead of addressing the persistent, albeit largely preventable, burden of oral diseases. >More