MediScan AI Data Security

INFORMATION SECURITY POLICY FRAMEWORK OVERVIEW

(HIPAA / HITECH & BEST PRACTICES)

Ensuring the security and privacy of healthcare data is crucial for compliance with the Health Insurance Portability and Accountability Act (HIPAA) when using cloud-based software-as-a-service (SaaS) for medical record reviews. Below is a list of key policies that are regularly maintained by MediScan AI.

1. Access Control: 
  • Defines and enforces access controls to ensure that only authorized personnel have access to patient data.

  • Implements strong authentication mechanisms, such as multi-factor authentication, to protect user accounts.
2. Secure Software Development:
  • Defines integrated security requirements into the earliest phases of the software development life cycle including the planning and design stages.

  • Implements regular security testing and code reviews throughout the development process, including static analysis, dynamic analysis, and penetration testing. Conduct security assessments before software releases to identify and address vulnerabilities and ensure that security controls are effective.
3. Audit Logging and Monitoring:
  • Establishes procedures for logging and monitoring access to patient data.

  • Regular reviews of audit logs to detect and respond to any suspicious activities or security incidents.
4. Data Backup and Recovery:
  • Implements a robust data backup strategy to prevent data loss.

  • Defines procedures for regular data backups and test the restoration process to ensure data integrity.
5. Incident Response and Reporting:
  • An incident response plan outlining steps to be taken in the event of a security incident.

  • Establishes a process for reporting incidents promptly to the appropriate authorities and affected individuals, as required by HIPAA.
6. Physical Security:
  • Ensures physical security measures are in place to protect servers and infrastructure hosting patient data.

  • Defines access controls and monitoring mechanisms for physical data storage locations.
7. Mobile Device Security:
  • Specifies guidelines for the secure use of mobile devices to access patient information.

  • Enforces encryption, authentication, and remote wipe capabilities for mobile devices used to handle sensitive data.
8. Vendor Management:
  • Assesses the security practices of the SaaS provider and ensure they are HIPAA compliant.

  • Defines responsibilities and expectations for the SaaS provider in terms of security controls and incident response.
9. Training and Awareness:
  • Provides regular training to employees on HIPAA regulations, security policies, and best practices.

  • Ensures that staff members are aware of their roles and responsibilities in maintaining data security.
10. Risk Management:
  • Regular risk assessments to identify and mitigate potential security risks.

  • Implements risk management strategies to address vulnerabilities and ensure ongoing compliance.
11. Data Retention and Disposal:
  • Defines guidelines for the retention and secure disposal of patient data in accordance with HIPAA requirements.

  • Ensures that data is appropriately deleted when it is no longer needed for its intended purpose.
12. Breach Notification:
  • Defines Identification and assessment: Promptly identify and assess any security incidents or breaches that may compromise the confidentiality, integrity, or availability of protected health information (PHI). Establish a clear process for reporting and escalating potential breaches to the designated privacy and security officers for immediate investigation.

  • Notification processes: A systematic approach for determining whether a breach has occurred, including the extent of the breach and the individuals or entities affected. If a breach is confirmed, initiate the breach notification process in accordance with the Health Insurance Portability and Accountability Act (HIPAA) requirements and the breach notification rules under HITECH Act. This includes, notifying affected individuals, the Department of Health and Human Services (HHS), and other relevant parties within the specified timeframe. It's important to note that breach notification requirements under HIPAA and HITECH are time-sensitive, and covered entities as well as business associates are generally required to notify affected individuals after discovering a breach.
Timelines:
  • Individual Notification: Covered entities are required to notify affected individuals without unreasonable delay and no later than 60 days following the discovery of a breach.

  • Notification to HHS: If the breach affects 500 or more individuals in a single jurisdiction, covered entities must notify HHS contemporaneously with notifying the affected individuals.

  • Media Notification: If a breach affects more than 500 residents of a state or jurisdiction, covered entities must notify prominent media outlets serving the state or jurisdiction.
Penalties:
  • HITECH significantly increased the penalties for HIPAA violations and penalties can range from $100 to $50,000 per violation, up to a maximum annual penalty cap of $1.5 million per calendar year.

Type of Breach
Description
Fine per Violation
Maximum Annual Penalty
Tier 1 (Unknowingly)
The covered entity or business associate did not know and, by exercising reasonable diligence, would not have known the violation
$100 - $50K
$25K - $1.5M
Tier 2 (Reasonable Cause)
The violation was due to reasonable cause, not willful neglect
$1K - $50K
$100K - $1.5M
Tier 3 (Willful Neglect - Corrected)
The violation was due to willful neglect but was corrected
$10K - $50K
$250K - $1.5M
Tier 4 (Willful Neglect - Not Corrected)
The violation was due to willful neglect and not corrected
$50K +
$1.5M +

The policies outlined above provide a strong foundation for a Security Risk Assessment (SRA) for HIPAA and HITECH compliance. A comprehensive SRA should also involve a more detailed and systematic examination of potential risks and vulnerabilities.

Risk Analysis:

  • Detailed risk analysis to identify and assess potential risks to the confidentiality, integrity, and availability of electronic protected health information (ePHI).
  • Evaluates the likelihood and impact of identified risks.

Risk Mitigation and Management:

  • Implements risk mitigation strategies to address identified vulnerabilities.
  • Prioritizes risks based on their severity and potential impact on ePHI.

Gap Analysis:

  • Gap analysis to compare existing security measures against HIPAA requirements.
  • Identifies and addresses any gaps in policies, procedures, or technical controls.

Business Associate Agreements (BAAs):

  • Ensures that appropriate Business Associate Agreements are in place with third-party vendors and service providers handling ePHI.
  • Verify that BAAs include the necessary security and privacy provisions required by HIPAA.

Penetration Testing and Vulnerability Assessments:

  • Regular penetration testing and vulnerability assessments to identify and address weaknesses in the organization's systems.
  • Remediates vulnerabilities and ensure that security patches are applied promptly.

Security Incident Response Testing:

  • Tests the effectiveness of the incident response plan through simulated security incidents.
  • Evaluates the organization's ability to detect, respond to, and recover from security incidents.

Documentation and Record-Keeping:

  • Maintains thorough documentation of the Security Risk Assessment process, findings, and remediation efforts.
  • Keeps records of security incidents, responses, and updates to security measures.

Ongoing Monitoring and Auditing:

  • Implements continuous monitoring of security controls and conduct regular internal audits.
  • Monitors changes in the organization's infrastructure, systems, and policies to ensure ongoing compliance.

Regulatory Compliance Review:

  • Regular review and update policies and procedures to align with changes in regulatory requirements, including updates to HIPAA.

Contingency Planning:

  • Developing and testing contingency plans for data recovery and business continuity in the event of a security incident or disaster.

Cybersecurity Insurance:

  • Carry cybersecurity insurance to help mitigate financial risks associated with data breaches or security incidents.