If you work in healthtech or medical BPO, you already know that handling protected health information (PHI) comes with serious responsibility — and serious scrutiny. Clients want proof. Regulators want compliance. And increasingly, both want one thing: HITRUST certification.
But getting there doesn’t begin with the audit. It begins long before, with a structured HITRUST readiness checklist — your organisation’s internal roadmap to certification success.
This guide breaks down every step of that checklist, from policies to pre-assessment, so your team knows exactly what’s expected and how to prepare.
What Is a HITRUST Readiness Checklist?
A HITRUST readiness checklist is a structured framework used before a validated assessment to evaluate your organisation’s alignment with the HITRUST CSF (Common Security Framework). Think of it as a dress rehearsal — an internal audit of your security posture before the real assessment begins.
HITRUST-certified organisations have a significantly lower breach rate, with only 0.59% reporting breaches in 2024, making certification a powerful trust signal for healthcare clients and partners alike. For healthtech companies and medical BPOs handling large volumes of patient data, this isn’t just good practice — it’s often a contract requirement.
Step 1: Establish Policies & Procedures
Policies form the backbone of HITRUST compliance. They must be formalised, approved by management, and consistently implemented. Each policy should clearly define roles, responsibilities, review frequency, and enforcement procedures. Version control and approval records are critical for audit evidence.
For medical BPOs in particular, this means having documented policies covering data access, incident response, remote work security, and third-party vendor management — not as theoretical documents buried in a shared drive, but as actively enforced, regularly reviewed frameworks.
Key policies to have in place include an Information Security Management Program (ISMP), access control policy, data classification policy, and a business continuity/disaster recovery plan.
Step 2: Build Your Documentation Repository
Policy alone isn’t enough — you need proof that those policies are operational. Documentation demonstrates that your controls are not theoretical but actively working. Maintaining a centralised compliance repository significantly improves audit efficiency and keeps your team audit-ready at all times.
Your documentation package should include risk assessments, audit trails, system inventories, evidence of control implementation, and records of any past security incidents and how they were resolved. Healthtech companies with cloud-based environments should pay particular attention here — cloud sprawl and weak governance can surface unexpected issues during the readiness phase or, worse, during the actual assessment.
Step 3: Conduct a Gap Analysis
This is arguably the most revealing step. A gap analysis compares your current controls against HITRUST CSF requirements to pinpoint exactly where your organisation falls short — before an external assessor does it for you.
The first step is performing a self-assessment to identify areas where your security programme may not align with HITRUST CSF requirements. This helps prioritise improvements and allows you to review the resources needed to address deficiencies before the formal assessment begins.
Medical BPOs often discover gaps in areas like encryption standards, third-party vendor risk management, and access control logging. Identifying these early allows you to develop Corrective Action Plans (CAPs) and remediate before the formal assessment clock starts.
Step 4: Security Awareness Training
Compliance isn’t just a technology problem — it’s a people problem. HITRUST requires documented evidence of training participation, covering not just technical staff but all employees who interact with protected data.
For healthtech teams and medical BPO staff — many of whom handle ePHI daily — training must cover phishing awareness, password hygiene, data handling protocols, and incident reporting procedures. Training should be conducted at onboarding and refreshed at least annually, with attendance records maintained as audit evidence.
Step 5: Run Internal Audits
Before you invite any external assessor in, run your own internal audit to stress-test your controls. Basing your readiness judgement solely on policies and interviews is not enough — you need to inspect evidence and observe critical processes to validate assumptions and verify compliance.
Internal audits should test whether controls are not just documented, but actually operating as intended — for example, validating that new hires genuinely complete security training, or that access controls are correctly restricting unauthorised users from PHI systems.
Step 6: Pre-Assessment Validation
Once internal audits are complete, a pre-assessment with an authorised external party gives you an objective benchmark. The readiness assessment includes a combination of interviews, evidence collection, control testing, and physical inspection — with each control area scored in accordance with HITRUST’s detailed scoring methodology.
This pre-assessment surfaces any remaining gaps before they affect your formal certification score and gives leadership a realistic picture of where the organisation stands.
How Long Does HITRUST Readiness Take?
Most organisations require six months to a year to complete the scoping process, readiness assessment, and certification. Healthtech startups and lean medical BPOs often underestimate this timeline — especially if documentation is scattered or policies need to be written from scratch.
Starting early, securing executive buy-in, and working with a HITRUST-experienced consultant can meaningfully compress this timeline and reduce costly remediation cycles.
Ready to Start Your HITRUST Journey?
HITRUST readiness isn’t a one-time project — it’s the foundation of a mature security programme. For healthtech companies and medical BPOs looking to win enterprise clients, protect patient data, and demonstrate credible compliance, a well-executed readiness checklist is where it all begins.
Start with a gap analysis. Build your policies. Train your people. Then certify with confidence.
Want help mapping your organisation’s HITRUST readiness? Contact Global Quality Services and get a customised readiness roadmap — built for healthcare operations like yours.
Frequently Asked Questions
Q: Is HITRUST mandatory for healthcare organisations?
HITRUST certification is not a federal mandate, but it is increasingly required by enterprise healthcare clients, health plans, and partners as a contractual condition. For medical BPOs bidding on large healthcare accounts, it is effectively non-negotiable.
Q: What are the three types of HITRUST certification?
HITRUST offers three assessment tiers — e1 (essential, 44 controls), i1 (intermediate), and r2 (risk-based, most comprehensive). With the release of CSF version 11, each certification option is stackable, meaning organisations can start with e1 and graduate to i1 and then r2 over time with minimal lost effort.
Q: Do small healthtech companies need HITRUST?
Yes. Small organisations benefit significantly from structured readiness planning to ensure efficient certification and avoid costly remediation during assessment. The e1 tier was specifically designed as an accessible entry point for smaller teams.
Q: Is a gap analysis required?
It’s not mandatory, but it is strongly recommended. Skipping it typically leads to low scores or failed controls during the validated assessment.
Q: How much does HITRUST certification cost?
Costs vary based on assessment type, organisation size, and scope. The e1 assessment is the most accessible entry point, while the r2 is the most comprehensive — and most expensive. Budgeting for both the assessment fee and remediation work is advisable.
