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.

What Health Systems Really Want: 5 Health Tech Takeaways From DiMe’s New AI Playbook

Oct 23

Written By L Trotter II

TL;DR

Health systems are interested in AI but increasingly skeptical of its promises. The Digital Medicine Society (DiMe) has released a new AI Implementation Playbook, helping both vendors and health systems bridge the gap between innovation and adoption.

If you’re a growth-stage health tech company selling AI-powered solutions, this Playbook is your roadmap for success. Here are the five essentials you must master to turn pilots into partnerships!

Checkout the full breakdown Here

1. Solve the Right Problem

Most AI vendors start with the tech.

Health systems start with the problem.

DiMe’s Playbook emphasizes aligning AI solutions with real-world clinical and operational pain points (e.g., clinician burnout, capacity, and patient throughput.)

If your AI can’t demonstrate measurable value in these areas, it won’t survive the procurement review.

Lead your pitch with outcomes, not algorithms.

Tie your use case directly to measurable ROI and reduced burden for end users.

Health Tech Sales Strategist Brendan McAdams talks about this more here.

2. Readiness and Governance Matter

According to DiMe, successful AI deployment requires mutual readiness between the vendor and health system.

Health systems are demanding AI governance frameworks that include model ethics, validation, accountability, and cybersecurity.

Vendors must be prepared to show documentation of how their model is trained, tested, secure, and monitored.

Use governance as your trust signal

A strong cybersecurity and governance framework makes health systems more comfortable partnering with startups.

Book a 15-minute vCISO strategy call to discuss aligning your AI Governance strategy with health system standards 👈

3. Evidence Wins Every Time

Health systems buy on evidence!

The Playbook urges vendors to back every claim with peer-reviewed studies, real-world validation, and bias testing.

Demonstrating safety, efficacy, and fairness is the new baseline.

Trust is earned through proof.

Make validation stats part of your sales narrative, versus an afterthought.

4. Integration Is Non-Negotiable

Even the most sophisticated AI model fails if it doesn’t integrate seamlessly into existing workflows.

DiMe stresses that health systems expect vendors to embed AI into current EHR and workflow structures, not disrupt them.

Complex deployments and interoperability challenges can be deal-breakers.

Integration is your competitive advantage.

Invest in FHIR, data mapping, and user-centric design so your AI enhances, not hinders clinical efficiency.

5. Continuous Oversight and Model Maintenance

AI performance drifts.

Health systems want partners who monitor, retrain, and refine models to prevent bias, degradation, security vulnerabilities, and inaccurate outputs.

DiMe calls for a lifecycle approach to AI oversight, ensuring accountability after go-live.

Reliability is the new success metric.

AI oversight earns renewals and protects your reputation.

Action Steps for Health Tech Companies

If your company is aiming to sell AI solutions to hospitals, clinics, or large health systems, start here:

Map your solution against DiMe’s five pillars.
Identify documentation gaps (validation, explainability, governance).
Run cybersecurity and algorithmic risk assessments before demos.
Develop a transparent buyer packet with governance, cybersecurity, and ROI metrics.
Align your Go To Market (GTM) strategy with health system readiness frameworks.

Don’t sell AI...sell reliability, transparency, and trust!

Download the HIPAA EXP Guide to ensure your cybersecurity strategy supports your sales story 👈

FAQ

What do health systems prioritize when evaluating AI vendors?

They look for evidence of safety, explainability, and operational fit. Solutions that solve specific, measurable problems.

Why does governance matter so much in AI implementations?

Governance ensures accountability, mitigates bias, and gives buyers confidence that your model is ethical and safe.

How can startups prove ROI and safety without full clinical trials?

By publishing validation data, pilot outcomes, or performance benchmarks in controlled deployments.

What is model drift and why does it affect adoption?

Model drift occurs when AI accuracy declines over time due to changing data patterns. Continuous monitoring and retraining are critical.

Final Thoughts

Health systems aren’t opposed to innovation but it has to be reliable.

DiMe’s Playbook is a reality check...and a good one!

AI adoption is about building smart models that are trustworthy, secure, transparent, and aligned with provider goals!

P.S. Which of DiMe’s five AI essentials do you think health tech vendors overlook the most?

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