Industry Focus — Healthcare-Adjacent
HIPAA Security Rule readiness — without a compliance team on staff.
If your organization handles protected health information — as a covered entity or a business associate — the HIPAA Security Rule requires a documented, operational security program. Most healthcare-adjacent SMBs don’t have one. We build it with you.
What HIPAA requires — in plain terms
The HIPAA Security Rule applies to covered entities (healthcare providers, health plans, healthcare clearinghouses) and their business associates — any organization that creates, receives, maintains, or transmits protected health information (PHI) on behalf of a covered entity.
Requirements include: a documented risk analysis, administrative safeguards (policies, workforce training, access management), physical safeguards (workstation policies, device controls), and technical safeguards (encryption, audit controls, access controls). The HITECH Act extended HIPAA’s reach to business associates and increased penalties.
The question isn’t whether HIPAA applies to you. The question is whether your current controls actually satisfy the requirements — and whether you can demonstrate that to a regulator.
Where the gaps usually are
- No documented risk analysis — or one that was done once and never updated
- PHI on personal devices or shared drives with no access controls
- Business associate agreements that haven’t been reviewed against current operations
- Email still used to transmit PHI without encryption
- No workforce training in the past 12 months
- Breach notification procedures that exist on paper but have never been rehearsed
What Klaravex does for healthcare-adjacent clients
Gap Analysis
A structured HIPAA Security Rule gap analysis — mapping your current technical and administrative controls against the required safeguards. The output is a prioritized remediation list, not a generic checklist.
M365 and Google Workspace Configuration
We configure both platforms to meet HIPAA technical safeguard requirements — email encryption, audit logging, access controls, conditional access policies, and DLP rules.
BAA Coordination
We help you identify who needs a BAA, review whether existing BAAs are adequate, and flag gaps. Legal review of your BAAs requires qualified healthcare counsel.
Policy Development
Administrative safeguard documentation — security policies, workforce training program, breach notification procedure, media disposal procedure — built to your environment.
Ongoing Monitoring
After initial remediation: ongoing security monitoring and quarterly reviews. Recommended: Assurance for gap analysis, monitoring, and policy documentation. Directive if preparing for an OCR audit, BAA review, or if you need a vCISO to own the program.
HIPAA compliance determinations require qualified healthcare counsel. Klaravex provides technical and operational readiness advisory — not legal advice, not audit attestation, and not certification. The presence of a Klaravex-managed security program does not constitute a guarantee of HIPAA compliance. Organizations with covered entity or business associate relationships should obtain independent legal analysis of their HIPAA obligations before relying on any advisory program.
FAQ
Does Klaravex sign a BAA?
Yes. We enter into a Business Associate Agreement with clients whose work involves PHI, where required.
Can Klaravex certify that we are HIPAA compliant?
No. HIPAA compliance is a legal and operational determination, not a certification issued by a vendor. Klaravex provides readiness advisory and technical implementation — not legal compliance opinions or audit attestations.
We’re a business associate, not a covered entity. Does HIPAA still apply?
Yes. Business associates are directly subject to HIPAA Security Rule requirements under HITECH. If you handle PHI on behalf of a covered entity, the rules apply to you.
What if we’ve never done a risk analysis?
That is the most common starting point. A HIPAA risk analysis is the foundation of the Security Rule. We help you build one from scratch.
Ready to assess your HIPAA readiness?