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Testing and defence led by a published security researcher with five CVEs, including a CVSS 9.1 Mirai botnet kill-switch.

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SOC 2, ISO, CPCSC, and the Canadian privacy stack, run end to end with an independent auditor.

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HIPAA · HealthTech

HIPAA for HealthTech

Your customer, investor, or auditor just made HIPAA a requirement. Here is what it takes, how long it runs, and how a Toronto team gets you there. Most clients are audit-ready in 8 to 12 weeks.

If your HealthTech product touches protected health information, HIPAA is not optional: it is US law. We run the risk analysis, build the safeguards, and get your BAAs in order.

Book a free readiness call Full HIPAA service

Why HealthTech companies need HIPAA

  • HIPAA is US federal law governing protected health information (PHI); handling PHI makes you a covered entity or business associate.
  • The HIPAA Security Rule requires a documented risk analysis and administrative, physical, and technical safeguards.
  • Business Associate Agreements (BAAs) are mandatory with every vendor that touches PHI on your behalf.
  • Breach-notification obligations mean you need incident response procedures before, not after, an incident.

More context on this sector on our HealthTech industry page, and on the framework itself on our HIPAA hub.

What our HIPAA engagement covers

Tailored to HealthTech, delivered by a Toronto security and compliance team led by a published security researcher, with our offensive-security partner where offensive testing is involved.

  • Business Associate Agreement (BAA) review across your vendor stack
  • PHI inventory and data-flow mapping
  • HIPAA Security Rule risk analysis across administrative, physical, and technical safeguards
  • Policies, workforce training, and access, audit-logging, and encryption controls for PHI
  • Breach-notification procedures and incident response runbooks
  • Documentation package you can show to customers and auditors

See the full HIPAA service page, or productized pricing for fixed-scope engagements.

Related pages

HIPAA for HealthTech: common questions

Is there a HIPAA certification?

No official HIPAA certification exists. Compliance is demonstrated through your risk analysis, safeguards, policies, and BAAs. We produce that evidence package.

Are we a covered entity or a business associate?

If you provide services to a covered entity and handle PHI, you are typically a business associate. We help you classify your role and obligations correctly.

What does a HIPAA risk analysis involve?

A documented assessment of risks to PHI across administrative, physical, and technical safeguards, with remediation. It is the foundation the Security Rule requires.

HIPAA for HealthTech, on your timeline

Book a free 30-minute discovery call. We will tell you whether this engagement fits, what it would cost, and when we could start.

Book a call Contact us

The same work, without the line item

Every readiness programme needs a control library, an evidence register, policies and a score for the board. Being quoted five figures a year for that is normal. Paying it is not.

traztech Workspace Other GRC platforms
Licence cost $0. Free forever, no card, no paid tier $7,500 to $50,000 a year, on an annual contract
Control library, evidence register, policy templates, risk register, vendor questionnaires, readiness scoring Included Included
What it costs inside an engagement with us $0. You need a workspace either way Unchanged. The subscription sits on top of the fee
What it does to your audit quote $11,000 off a five-figure quote on one engagement, for a documented readiness position Nothing. The audit firm prices your readiness, not your tooling

Pricing in the right column is what compliance automation platforms are publicly reported to charge; none of them publish a number, so treat it as a range rather than a quote. The $11,000 came off the audit firm's own number once the readiness position was documented (the engagement). Where a paid platform is the better buy, and the fuller comparison, is on the Workspace page.

Track record

Who is actually doing the work

We are deliberately not a large firm, and we would rather show you the work than a wall of logos. Here is what is behind the advice.

5
Published CVEs, including a CVSS 9.1
76
Controls taken from nothing to a passed SOC 2 Type II
Zero
Exceptions on that Type II report
75 days
Readiness window we have hit every time we have run it
20+
Penetration testing engagements delivered

Published vulnerability research

Five published CVEs. CVE-2024-45163 (CVSS 9.1) is a flaw in the Mirai botnet itself, which gave defenders a way to shut down attacker infrastructure. CVE-2026-42626 takes HP ENVY 5000 printers offline from any unauthenticated device on the same network.

The printer is the one that matters on a compliance page: an asset nobody counts as a computer, on a flat network, downed by a device that never had to log in. Auditors ask how controls fail. We have found out first-hand.

A SOC 2 Type II built from nothing

At Humera, a venture-backed US security company, Jacob built the compliance programme in-house from nothing: no report, no policies, no documented controls. It ended in a Type II attestation across 76 controls with zero exceptions, on a team of 15.

The platform held 99.9% uptime throughout, which is the part most readiness projects get wrong: controls are easy to design and hard to retrofit onto a system people already depend on.

Recent engagements

For a Waterloo data centre operator we ran SOC 2 Type II and ISO 27001:2022 together rather than one after the other, across a production campus, an AI compute platform and a self-hosted collaboration stack. Scoped so further Ontario and Quebec sites enter as they reach production. Findings delivered and remediated.

For an Ontario medtech company putting an AI clinical assistant in front of practitioners, we ran the gap analysis and built the evidence programme behind their SOC 2.