What is the HIPAA Security Rule?

The HIPAA Security Rule establishes national standards to protect the confidentiality, integrity, and availability of electronic protected health information (ePHI) through administrative, physical, and technical safeguards.

What is considered a HIPAA violation in cybersecurity?

A HIPAA violation occurs when PHI or ePHI is impermissibly used or disclosed or insufficiently safeguarded. Common causes include weak access controls, missing risk analyses, unencrypted devices, improper workforce training, and delayed breach reporting.

What are administrative, physical, and technical safeguards?

Administrative safeguards are policies, procedures, and training. Physical safeguards protect facilities and devices. Technical safeguards include access controls, audit logging, transmission security, and encryption.

Is a HIPAA risk assessment required annually?

HIPAA requires a regular and thorough risk analysis but does not mandate a specific frequency. Many organizations perform it annually and whenever significant changes occur, such as new systems, vendors, or workflows.

What should a HIPAA risk assessment include?

It should identify where ePHI resides, evaluate threats and vulnerabilities, assess likelihood and impact, review current controls, document risk levels, and define prioritized remediation steps and timelines.

What is the role of encryption in HIPAA compliance?

Encryption is an addressable implementation specification. If reasonable and appropriate, it should be implemented for data at rest and in transit. If not implemented, the decision must be documented and an equivalent alternative safeguard applied.

What is a Business Associate under HIPAA?

A Business Associate is any person or organization, other than a workforce member of a covered entity, that creates, receives, maintains, or transmits PHI on behalf of a covered entity. Examples include cloud providers, IT support, billing services, and certain consultants. A Business Associate Agreement (BAA) is required before PHI access.

Do business associates need to be HIPAA compliant?

Yes. Business associates must implement appropriate safeguards for PHI, comply with applicable HIPAA requirements, enter into a BAA, report incidents and breaches, and ensure their subcontractors that handle PHI also comply.

What happens if a business associate causes a breach?

Both the covered entity and the business associate have obligations. The business associate must investigate, mitigate, and notify the covered entity. Breach notifications to individuals, HHS, and in some cases the media may be required based on the incident size and circumstances.

How do I secure remote access to ePHI?

Use VPN or zero-trust access, require multi-factor authentication, enforce least-privilege access, encrypt devices, manage endpoints and patches, disable local data storage when possible, and monitor logs for suspicious activity.

Can employees use personal devices under HIPAA?

Yes, if governed by a BYOD policy that enforces device encryption, screen locks, remote wipe, mobile device management, separation of work data, and prohibits storing ePHI in unsecured apps or locations.

What is considered a HIPAA data breach?

A breach is an impermissible use or disclosure of unsecured PHI that compromises its security or privacy, such as ransomware, lost or stolen devices, misdirected emails, or unauthorized access, unless a documented risk assessment shows a low probability of compromise.

How soon must a HIPAA breach be reported?

Affected individuals must be notified without unreasonable delay and no later than 60 days after discovery. Reporting to HHS depends on the number of affected individuals; large breaches (500 or more) require more immediate reporting and, in some cases, media notice.

What are the penalties for HIPAA violations?

HIPAA penalties vary by tier based on level of culpability, with per-violation amounts and annual caps per violation type. Enforcement may include corrective action plans, settlement amounts, and monitoring. Actual amounts depend on the facts and current HHS guidance.

Can my practice be audited for HIPAA compliance?

Yes. HHS’s Office for Civil Rights conducts audits and investigations, particularly after breaches or complaints. Maintaining documentation, training records, and current risk analyses helps demonstrate compliance readiness.

What documentation is required to prove HIPAA compliance?

Keep current risk analyses, remediation plans, security and privacy policies, workforce training logs, incident response procedures, business associate agreements, access audit logs, and evidence of ongoing monitoring and evaluations.

HIPAA Compliance Best Practices Every Health Tech Vendor Must Master

Nov 6

Written By L Trotter II

Selling to health systems means playing by HIPAA's rules. Health Tech vendors have always been under the same scrutiny as covered entities, and compliance can make or break a deal.

Today, health systems aren’t just asking, “Can your tech work?” They’re asking, “Can we trust you with patient data?”

Today I'm sharing seven HIPAA Compliance best practices every health tech company must master to build trust, win contracts, and grow responsibly based on my experience.

Download the HIPAA Exposure Guide to identify the compliance controls buyers expect!

Why HIPAA Compliance Matters for Health Tech Vendors

If your product processes, transmits, or stores Protected Health Information (PHI), you’re classified as a Business Associate under HIPAA.

Health systems now assess vendors not just on innovation, but on data stewardship and compliance maturity.

During procurement reviews, expect to be evaluated on:

Your HIPAA documentation and risk assessments
Security controls and encryption standards
Breach notification procedures
Evidence of ongoing monitoring and workforce training
Data Lifecycle Management

✅ Compliance is a sales enabler. A mature compliance posture speeds procurement and builds credibility with health systems.

1. Conduct Comprehensive HIPAA Risk Assessments

Health systems want to see that you’re proactive, not reactive. A HIPAA risk assessment should be performed annually or whenever your platform undergoes significant changes.

Include:

Technical safeguards: encryption, MFA, cloud configuration checks
Administrative safeguards: role-based access, security governance
Physical safeguards: device and facility security

✅ A HIPAA Risk Assessment is different then a HIPAA Gap Assessment. Both are regulatory requirements but risk assessments happen more frequently.

👉 Download our HIPAA Exposure Guide to see how you stack up to risks.

2. Build Governance and Documentation That Stand Up to Scrutiny

Compliance maturity starts with clear accountability and traceability (i.e. Governance.)

Establish a security lead or vCISO, to ensure leadership is engaged in compliance oversight. Maintain up-to-date documentation that maps to:

The Privacy Rule (data use, consent, disclosure)
The Security Rule (technical and administrative safeguards)
The Breach Notification Rule (incident timelines, procedures)

✅ Written policies don't equal trust. What they say must be aligned with what you do! Health systems trust vendors with policies that mirror their actions.

3. Ensure Technical and Physical Safeguards Are Ironclad

Cloud misconfigurations and poor access controls are still among the top causes of HIPAA violations.

Focus on:

Data encryption (in transit and at rest)
Identity and access management with least privilege
Network segmentation and secure logging
Secure development practices for your product or platform

✅ Your technical architecture is part of your brand reputation. Health systems want to see that you’ve invested in security from the start.

4. Manage Vendors and BAAs Like Your Brand Depends on It

Health systems expect your vendor ecosystem to be as compliant as theirs.

That means executing Business Associate Agreements (BAAs) with every third-party that touches PHI and validating their security posture.

Implement a third-party risk management (TPRM) program that includes:

Vendor inventories
Annual security attestations
BAA renewals and version tracking

✅ Your vendors can compromise your compliance. Act like a health system—demand proof.

👉 Use our HIPAA Exposure Guide to audit your partners.

5. Train, Test, and Track Your Workforce

HIPAA training is mandatory, but effectiveness varies widely.

Your program should go beyond annual slide decks and include:

Role-based education (developers, support, leadership)
Phishing simulations and awareness campaigns
Real-world incident scenarios

✅ A educated team is a confident team. Health systems will ask how your employees are trained to handle PHI securely. Also, make sure you have Sanctions to accompany training. If your workforce doesn't take it seriously, your wasting time.

6. Prepare for Incident Response Before It’s Needed

Breach response isn’t about if, it’s about when.

Health systems want assurance that you have an Incident Response Plan (IRP) that’s:

Documented
Tested at least once per year
Includes executive, legal, and technical stakeholders

✅ Health systems value vendors who understand their breach responsibilities and time commitments.

7. Monitor, Audit, and Improve Continuously

HIPAA compliance isn’t static. Health systems expect vendors to audit regularly and demonstrate continuous improvement.

Track:

Access logs and alert on anomalies
Policy reviews and versioning
Vendor assessments
Model drift or data lifecycle changes (for AI-powered platforms)

✅ Continuous improvement shows maturity.

Actionable Next Steps for Health Tech Vendors

If you’re preparing to sell to health systems:

Audit your HIPAA program against these seven best practices.
Document your governance and risk mitigation strategies.
Validate every vendor relationship and BAA.
Integrate security and compliance into your sales deck, it builds buyer trust.

FAQ

Do all health tech vendors need to follow HIPAA?

Yes. If your product handles PHI on behalf of a covered entity, you’re a business associate under HIPAA.

What documentation will health systems ask for during vendor vetting?

Expect requests for risk assessments, policy summaries, BAAs, and recent audit findings.

How quickly must a vendor report a breach?

Under HIPAA, you must notify the covered entity without unreasonable delay, no later than 60 days after a breach.

What’s the #1 compliance mistake startups make?

Assuming HIPAA only applies once they scale. Compliance must start before your first health system pilot.

Final Thoughts

Health systems are looking for vendors who protect patient data as fiercely as they innovate. The earlier you build compliance into your culture, the faster you’ll move through security reviews and close enterprise deals.

👉 Get the HIPAA Exposure Guide and start strengthening your compliance foundation today.

L Trotter II

As Founder and CEO of Inherent Security, Larry Trotter II is responsible for defining the mission and vision of the company, ensuring execution aligns with the business purpose. Larry has transformed Inherent Security from a consultancy to a cybersecurity company through partnerships and expert acquisitions. Today the company leverages its healthcare and government expertise to accelerate compliance operation for clients.

Larry has provided services for 12 years across the private industry developing security strategies and managing security operations for Fortune 500 companies and healthcare organizations. He is influential business leader who can demonstrate the value proposition of security and its direct link to customers.

Larry graduated from Old Dominion University with a bachelor’s degree in Business Administration with a focus on IT and Networking. Larry has accumulated certifications such as the CISM, ISO27001 Lead Implementer, GCIA and others. He serves on the Board of Directors for the MIT Enterprise Forum DC and Baltimore.

https://www.inherentsecurity.com