Keep patients safe and research credible
Healthcare and life sciences organizations must protect patient privacy, maintain data integrity for clinical care and trials, and meet tight audit standards. We design security and operational controls that protect PHI, secure medical devices, lock down research data, and produce the evidence auditors and partners expect.
Snapshot first - measure before you commit
We start by measuring your current state so scope and recommendations are based on facts. The Snapshot delivers:
- An inventory of EHRs, clinical systems, research datasets, lab systems, and connected medical devices.
- A data flow map showing where PHI and sensitive research data move and how they are accessed.
- A gap analysis for access controls, logging, backup and recovery, and vendor access.
- Quick wins and high-risk items that reduce patient safety and compliance exposure first.
- You get a prioritized roadmap to act on immediately.
Scope and objectives - agreed after we measure
After the Snapshot we confirm the program boundaries and success criteria. Together we set:
- Which clinical systems, research projects, and devices are in scope.
- Recovery and integrity targets for care systems and research data.
- Evidence and reporting needs for audits, institutional review boards, and partners.
- Named owners and acceptance criteria for each deliverable.
- This keeps work focused on protecting patients and validated research outcomes.
What we protect and why it matters
- Patient data and clinical workflows - protect electronic health records, interfaces, and the continuity of care.
- Research and trial data integrity - ensure provenance, immutability where required, and auditable trails for study data.
- Medical and lab device security - secure device connectivity, firmware management, and safe update processes.
- Third-party and vendor access - control and log contractor and cloud access to sensitive systems.
- Regulatory and contractual readiness - produce evidence for audits, certifications, insurers, and clinical partners.
Our five-step client process
- 360-degree Snapshot (five days) - inventory systems and devices, map data flows, test logging and backups, and deliver a prioritized readiness roadmap.
- Scope and Objectives - agree which systems and studies to protect, set integrity and recovery targets, and name owners for controls and evidence.
- Design and policy - create pragmatic policies, device and network segmentation plans, least-privilege access models, and evidence mappings for audits.
- Implement and validate - enforce baselines, secure device and vendor access, automate evidence capture, and run restore and integrity tests during maintenance windows.
- Operate and demonstrate - scheduled drills, tabletop exercises, continuous monitoring, role-based training, and an audit pack that proves controls work in production.
Deliverables - what you will receive
- Snapshot Report - system and device inventory, data flows, risk rating, and a prioritized roadmap.
- Signed Scope and Objectives - agreed targets, owners, and acceptance criteria.
- Policy and control pack - patient-data handling, device security, vendor access, and research data integrity policies.
- Segmentation and access plan - network and logical zones separating clinical, research, and corporate systems.
- Evidence and audit bundle - logs, retention rules, signed procedures, and a tracker for required artifacts.
- Backup and recovery playbooks - tested restores for clinical systems and research datasets with integrity checks.
- Vendor governance pack - BAA-ready templates, remote access rules, and periodic revalidation workflows.
- Training and handover - short role-based training for clinical and research staff and operator runbooks.
Timeline and expectations
- Days 1 to 5 - Snapshot and prioritized roadmap, with our five-day clarity guarantee.
- Week 2 - Scope and Objectives sign-off and draft design.
- Weeks 3 and up - staged implementations, device and vendor coordination, and validation tests aligned to maintenance windows.
- Post-implementation - governance checks, quarterly drills, and scheduled evidence collection for audits.
Acceptance criteria - how success is measured
- Snapshot delivered and Scope and Objectives signed by stakeholders.
- Critical clinical systems and research datasets included and verified.
- Segmentation and least-privilege access implemented for scoped environments.
- Backup and restore tests pass with documented integrity checks for research data and clinical records.
- Vendor access is governed, logged, and periodically revalidated.
- Audit evidence is organized and available within agreed timeframes.
Risks and how we mitigate them
- Changes disrupt clinical operations - we schedule work during maintenance windows, rehearse changes, and provide rollback options.
- Legacy devices cannot be patched - we apply network isolation, compensating controls, and strict vendor gating.
- Data integrity issues in research - we use versioning, immutable retention where required, and reproducible restore tests.
- Vendor or cloud exposure - we require contractual protections, time-bound access, and strong device posture checks.
- Regulatory or reputational exposure - we maintain an evidence bundle and run tabletop exercises to validate communications and response.
Three simple next steps - protect patients and research now
- Book a free 30-minute Clarity Consultation - we confirm the systems and studies you must protect and the immediate benefits of stronger controls.
- We run the five-day Snapshot - you get an OT and IT inventory, data flow map, and a prioritized roadmap tied to patient safety and research integrity.
- We kick off Week 1 sprint - Delivery assigns the lead, we finalize scope and objectives, and begin staged remediation and validation so you start reducing risk quickly.