For each criterion, select the option that best describes your current state. Each selection has a point value that contributes to your overall score.

Scoring Guide:

3 Points = Fully Implemented (Complete, documented, regularly tested)
2 Points = Partially Implemented (In progress, partial coverage, some gaps)
1 Point = Not Implemented (Missing, not started, significant gaps)

SECTION 1: Regulatory Compliance Mastery

HIPAA, HITRUST, FDA 21 CFR Part 11

1.1 Comprehensive Compliance Audit:

Have you conducted a recent, comprehensive audit of your HIPAA Security Rule compliance, including technical, administrative, and physical safeguards?

Fully Implemented: Annual comprehensive audits with documented remediation. Partially Implemented: Audits conducted periodically, but not comprehensive or lacking follow-up. Not Implemented: No recent or comprehensive HIPAA security audits performed.

1.2 GxP & FDA 21 CFR Part 11 Compliance:

For life science organizations, are your electronic records and signatures compliant with GxP and FDA 21 CFR Part 11 regulations?

Fully Implemented: All relevant systems and processes are validated and compliant. Partially Implemented: Some systems are compliant, but gaps exist or validation is incomplete. Not Implemented: Compliance with GxP/21 CFR Part 11 is not actively managed.

1.3 HITRUST CSF Certification Strategy:

Do you have a clear strategy and timeline for achieving or maintaining HITRUST CSF certification?

Fully Implemented: Certified or actively working towards certification with dedicated resources. Partially Implemented: Aware of HITRUST, but no formal strategy or resources allocated. Not Implemented: No current plans or knowledge of HITRUST CSF.

SECTION 2: Digital Health Innovation Security

Securing Your Research, Development & Patient-Facing Tech

2.1 R&D Data Lifecycle Security:

Are robust security controls (encryption, access control, DLP) applied consistently across the entire R&D data lifecycle?

Fully Implemented: End-to-end security measures are in place and regularly audited. Partially Implemented: Some controls exist, but inconsistencies or gaps are present. Not Implemented: R&D data security is ad-hoc or lacks comprehensive lifecycle protection.

2.2 Medical Device & IoT Security:

Do you have a dedicated strategy for securing networked medical devices, clinical IoT, and remote patient monitoring solutions?

Fully Implemented: Comprehensive security strategy with dedicated management tools. Partially Implemented: Some devices are secured, but a holistic strategy is missing. Not Implemented: Medical device/IoT security is not a primary focus.

2.3 Telehealth & Remote Access Security:

Are your telehealth platforms, remote diagnostic tools, and virtual care access points secured with robust authentication, encryption, and audit trails?

Fully Implemented: All remote access and telehealth secured with best practices. Partially Implemented: Some remote access is secured, but inconsistencies or gaps exist. Not Implemented: Telehealth and remote access security is not a priority.

SECTION 3: Executive & Board Reporting

Communicating Risk & Demonstrating ROI

3.1 Risk & Compliance Reporting:

Do you regularly provide clear, actionable cybersecurity risk and compliance reports to executive leadership and the board?

Fully Implemented: Regular, comprehensive reports with financial impact. Partially Implemented: Some reporting, but lacks consistent detail or executive focus. Not Implemented: Infrequent or no formal cybersecurity reporting to leadership.

3.2 Cybersecurity Investment ROI:

Can you clearly articulate the return on investment for cybersecurity initiatives, demonstrating how they safeguard innovation?

Fully Implemented: Clear ROI metrics and narratives are regularly presented. Partially Implemented: Some attempts to show value, but lacks consistent quantification. Not Implemented: Cybersecurity is viewed as a cost center, without ROI justification.

3.3 Incident Response Communication Plan:

Is there a defined and tested communication plan for cyber incidents that includes stakeholders from legal, PR, executive, and clinical operations?

Fully Implemented: Tested plan with clear roles and communication channels. Partially Implemented: Basic plan exists, but lacks comprehensive stakeholder involvement or testing. Not Implemented: No formal communication plan for cyber incidents.

Executive Cybersecurity Blueprint

Assess Your Cybersecurity Readiness

Scoring Guide:

SECTION 1: Regulatory Compliance Mastery

SECTION 2: Digital Health Innovation Security

SECTION 3: Executive & Board Reporting

Your Healthcare Cybersecurity Readiness Score: 0 / 27

Is your innovation truly safeguarded?

Ready for a Deeper Assessment?