Inventory what you actually run (pipelines, tools, ML components), classify risk in an Annex III–oriented way for planning, and produce documentation-ready technical artefacts—without replacing qualified legal counsel.
Consulting · async-friendly · Research & clinical omics
For decision makers
What decision-makers should know first
Short plain-language context. GA4GH in one sentence. How inclusion fits us. The rest of this page keeps the full technical depth.
Clinical omics environments often accumulate AI/ML and rule-based components without a single authoritative inventory. Where systems may fall under high-risk profiles, obligations exist—but binding legal interpretation remains with your institution. We deliver technical screening, structured documentation support, and team enablement grounded in production workflows (containers, CI, reference data, variant interpretation paths).
What is GA4GH?
The Global Alliance for Genomics and Health (GA4GH) is an international initiative that defines shared technical interfaces for genomic data and analyses. Partners connect under clear contracts instead of rebuilding bespoke integrations for every link.
Synaptic Four combines rigorous engineering with an explicit, lived commitment to neurodiversity and autism inclusion. That is part of who we are—not an add-on to the tech story. More: About us Autism
This is technical consulting and documentation structuring. It is not legal advice, not representation before authorities, and not a substitute for qualified legal review when you need binding interpretation.
For systems that may qualify as high-risk under the EU AI Act, obligations cascade into risk management (Article 9), data governance for training/validation/test data (Article 10), bias considerations that can affect health and safety, and technical documentation (Article 11). Teams operating variant calling, omics pipelines, and MTB support stacks often need clarity on what is in scope and what “compliance work” means in engineering terms.
Generic AI Act programmes rarely speak fluent pipeline and variant-workflow reality. Generic bioinformatics consulting rarely produces EU AI Act–aligned documentation by design. We combine both so your screening and documentation drafts match how your tools truly behave in production.
Three stages from fast screening to deeper technical documentation and team literacy. Stages can be purchased independently after Stage 1.
Inventory of AI/ML components in use (tools, pipelines, algorithms), provisional Annex III–oriented classification, and a short written technical memo. No vendor lock-in. Legal assessment remains with your organisation. Timeline and handover: see “Pricing & how to start”.
Support preparing technical documentation aligned to Articles 9–11 themes at engineering depth: risk management artefacts, a data-governance concept for training/validation/test datasets, and a human oversight plan for deployed tools—especially relevant for MTB tooling, variant interpretation assistants, and diagnostic decision support workflows.
Practical workshop for teams who build and operate systems: what the EU AI Act means in day-to-day engineering terms, how to document human oversight operationally, and what an incident response rhythm can look like for bioinformatics operations.
This is not a generic legal retainer. It is evidence-oriented technical consulting grounded in production omics workflows (e.g. Snakemake, Nextflow, GATK, DeepVariant, ClinVar-driven processes), with explicit boundaries where external legal counsel is required.
Deliverables are engineering artefacts and planning memos. Final compliance positions, regulatory submissions, and sign-off remain with your qualified legal and regulatory owners.
Stage 1 — Screening: €1,800 net, fixed price, delivered remotely. Written scope fixed before kick-off. Delivery: 5–8 business days after kick-off.
Stage 2 — Technical compliance documentation: typically €4,000–10,000 net, project-based after Stage 1 results.
Stage 3 — AI literacy workshop: €1,200 net, half day remote or on-site (travel costs extra for on-site).
All stages can be commissioned separately. Initial call at no charge.