Security and Compliance Management HIPAA

HIPAA Security Rule and SOC 2 Basics for HealthTech

HIPAA Security Rule

The HIPAA Security Rule sets national standards to protect electronic protected health information (ePHI). Covered entities and business associates must implement administrative, physical, and technical safeguards that ensure the confidentiality, integrity, and availability of ePHI.

Key expectations include risk analysis and risk management, workforce security and training, access controls, authentication, and audit logging, integrity controls and transmission security, and contingency planning, including backup and disaster recovery.

Even when a HealthTech startup is not yet a covered entity, contracts with providers and payers often flow down equivalent obligations.

SOC 2 Type II

SOC 2 is an attestation report based on the AICPA's Trust Services Criteria. It evaluates whether a service organization's controls related to security, availability, processing integrity, confidentiality, and privacy are suitably designed and in operation over a defined period.

For HealthTech vendors, SOC 2 Type II shows potential customers that security controls are documented and monitored, incidents and changes are handled through defined processes, and evidence exists to prove how controls operate over time.

Many provider and payer security questionnaires now ask for SOC 2 reports alongside HIPAA documentation.

Where HIPAA and SOC 2 Overlap

Although HIPAA and SOC 2 come from different sources, they share themes that you can address with one integrated control set.

Common Areas

Risk assessments: HIPAA requires periodic risk analysis of ePHI. SOC 2 expects risk assessment processes for the system and data in scope.

Access control and authentication: Both expect unique user IDs, limited access based on role, and protections such as multi‑factor authentication.

Audit logging and monitoring: HIPAA requires audit controls to record and examine activity. SOC 2 looks for logging, monitoring, and alerting for security events.

Incident response and breach handling: HIPAA calls for procedures to respond to security incidents and breach notifications. SOC 2 evaluates incident response plans, evidence of execution, and communication processes.

Physical and environmental security: Data center or cloud provider controls can often be inherited through SOC reports and attestations.

When you treat HIPAA and SOC 2 as two lenses on the same operational reality, you can design controls once and map them to both sets of expectations.

Using HITRUST and Unified Frameworks

Many healthcare organizations use HITRUST as a way to harmonize HIPAA, SOC 2‑style controls, and other regulations. The HITRUST CSF framework brings together more than 60 security and privacy‑related standards into a unified control set.

For early‑stage HealthTech companies, HITRUST can feel heavy. You can still borrow useful ideas: start with a control catalog influenced by ISO 27001 and NIST‑style requirements, map each control to HIPAA citations and SOC 2 criteria, and mark which controls are mandatory now and which can wait until later funding stages.

Neutral Partners' SOC 2 framework page and SOC 2 for startups guide show how to shape a control set that fits early‑stage realities while preparing for more formal certifications.

Building a Realistic Security and Compliance Roadmap for Early‑Stage HealthTech

Clarify Buyer Expectations

Before designing a program, understand: Are your immediate buyers requiring only HIPAA language in contracts, or are they already asking for SOC 2 Type II? Do you handle ePHI directly, or are you processing de‑identified data at this stage? Are there integrations with EHRs or medical devices that raise specific regulatory questions?

Aligning roadmap decisions with actual revenue opportunities keeps the program right‑sized.

Establish a Unified Control Baseline

Create a simple control matrix with columns for control description, HIPAA Security Rule reference, SOC 2 criteria reference, and implementation owner and status.

Start with controls covering identity and access management for staff and admins, logging and monitoring of production systems, secure development and deployment practices, backup, disaster recovery, and tested restoration, and vendor management for cloud providers and key tools.

This becomes the backbone of your security and compliance management program.

Design for Evidence from Day One

For each control, ask: How will we prove this is implemented? Where will that evidence live, and how long do we keep it?

Use existing tools wherever possible. For example, cloud provider configuration histories as proof of encryption and access control, ticket histories showing access reviews and change approvals, and CI or deployment logs showing tests and approvals.

This keeps future HIPAA and SOC 2 assessments grounded in real operations rather than last‑minute document creation.

Phase Audits and Attestations

A common pattern for HealthTech startups is to implement HIPAA‑aligned controls and documentation, run a readiness assessment for SOC 2, focused on the security category, address gaps, then complete a SOC 2 Type I and move to Type II in a later period.

Managed services can help you maintain momentum between audits. Neutral Partners' managed compliance services focus on keeping controls and evidence current so audits become a confirmation, not a scramble.

Involve Leadership Without Slowing Delivery

Security and compliance management are strategic, not just technical. Involve founders and senior leaders in approving risk acceptance decisions, prioritizing remediation items that require resources, and communicating your posture to buyers and investors.

Keep operational detail with the teams that run the systems, but make sure leadership understands the narrative and tradeoffs.

FAQs

Do we have to be HIPAA compliant before starting SOC 2?
You should address HIPAA‑related obligations early if you handle ePHI or are signing BAAs with covered entities. In practice, many of the controls you implement for HIPAA will support SOC 2 as well. Treat HIPAA as the regulatory baseline and SOC 2 as the assurance layer that proves your controls to buyers.

Is HITRUST required for HealthTech vendors?
Not by default. Some large health systems prefer or require HITRUST certification for certain vendors, but many accept SOC 2 combined with strong HIPAA documentation. If your pipeline includes buyers that explicitly require HITRUST, it can justify the investment. Otherwise, you can still borrow structure from HITRUST without pursuing full certification.

How big does our team need to be to support both HIPAA and SOC 2?
You do not need a large team. Many early‑stage companies rely on one security or compliance lead, engineering and ops owners for key controls, and an external partner to build frameworks and run readiness checks. What matters most is clear ownership and evidence discipline, not headcount alone.

What happens if we change cloud providers or EHR integrations?
Significant infrastructure or integration changes should trigger updated risk assessments, reviews of BAAs and data flows, and adjustments to logging, backup, and access controls. Plan migrations so that compliance is part of the project rather than an afterthought. This keeps both HIPAA and SOC 2 narratives consistent during your next audit cycle.

Work with Neutral Partners to map HIPAA and SOC 2 into a single, practical control set so your HealthTech company can close enterprise healthcare deals without drowning in duplicate audits.