Legal, Privacy & Compliance Leads
In-house general counsel, privacy leads and compliance officers in life-sciences companies face a specialised regulatory field with generalist resources. GDPR and UK GDPR are the starting point; the Clinical Trials Regulation, national health-data rules, the EU AI Act, HIPAA and state privacy laws in the United States, and the expectations of ethics committees, notified bodies and hospital procurement follow. External counsel provides opinions; the implementation still lands on your desk.
What you need is a partner who works the way you do — precise instruments, documented positions, defensible files — and who has already solved the sector's recurring problems: the legal basis for research data across Europe, the transfer mechanism for a US sponsor, the wording of a German ICF, the classification of an AI diagnostic under the AI Act.
iliomad complements the in-house function rather than replacing it: as EU or UK representative where you have no establishment, as a delivery team for DPIAs, gap assessments and contract reviews, or as an AI Officer while the AI Act programme is built.
What an in-house lead needs from a specialist partner
The areas below are where life-sciences privacy diverges from general corporate privacy, and where a specialist saves the most time.
Clinical research relies on Art. 6(1)(f) or (e) with Art. 9(2)(j) GDPR in most Member States, on consent in others, and on specific national provisions (for example the French CNIL reference methodologies). The position must be documented per country and reflected in the ICF, the DPIA and the record of processing. iliomad maintains a country-by-country compliance wiki and applies it to your studies.
Art. 27 GDPR and UK GDPR representation is more than a mailbox: the representative must be named in notices, hold the record of processing, and handle authority and data subject contacts. iliomad Health Data SAS acts as EU representative from Boulogne-Billancourt and iliomad Health Data UK Ltd as UK representative from Cambridge, with a monthly activity report — see EU representative and UK representative.
A structured gap assessment across legal basis, transparency, data subject rights, governance, transfers, vendor management, security, retention and incident management, scored against the regulation with a remediation roadmap by priority. iliomad's gap analysis covers GDPR, UK GDPR, HIPAA, PIPEDA and other regimes in one exercise.
A pipeline of studies, products or vendors produces a pipeline of DPIAs, DPAs and security assessments that no in-house team of one can absorb. iliomad delivers them to a consistent methodology and template, with tracked changes and rationale, so that the in-house lead reviews rather than drafts — see DPIA and contractual review.
The AI Act adds a second regulatory layer: applicability and role qualification per system, classification under Art. 5, 6 and Annexes I and III, provider or deployer obligations, fundamental rights impact assessments where required, and AI literacy under Art. 4. iliomad delivers the applicability memorandum, the gap assessment and, where needed, the technical documentation — see AI compliance services.
Supervisory authority enquiries, partner audits and data breaches all have short deadlines and long consequences. iliomad prepares the file in advance, assesses breach severity with the ENISA methodology within hours, and drafts responses for your review. Our quality assurance reviews keep the file audit-ready between events.
How iliomad Health Data can help you
iliomad Health Data works with in-house legal and compliance leads as an extension of their function. We are certified data protection professionals (CIPP/E, CIPM, CDPO) with ISO 27001, 27005 and 9001 certification, and we work only in life sciences. You set the positions; we document and implement them, and we bring the sector precedent from more than thirty clients and 75 countries when the position is not yet set.
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