Compliance Resource

Massachusetts HIPAA Compliance Checklist

Everything Massachusetts healthcare and research organizations need to achieve and maintain HIPAA compliance. Built specifically for biotech labs, clinical trials, and health research facilities.

Updated for 2025
Massachusetts-specific requirements
Research facility focus
Section 1

Administrative Safeguards

Policies, procedures, and processes that manage the selection, development, implementation, and maintenance of security measures.

Security Management Process

Implement policies and procedures to prevent, detect, contain, and correct security violations.

  • Conduct risk analysis of PHI systems and data flows
  • Implement risk management strategies to reduce identified risks
  • Create sanction policy for workforce members who violate policies
  • Regular review and modification of security measures

Assigned Security Responsibility

Designate a security official responsible for developing and implementing security policies.

  • Appoint a Chief Information Security Officer (CISO) or equivalent
  • Document security official's responsibilities and authority

Workforce Security

Ensure all workforce members have appropriate access to PHI and prevent unauthorized access.

  • Background checks and screening procedures for positions with PHI access
  • Termination procedures for removing access when employment ends
  • Procedures for granting, modifying, and revoking access

Information Access Management

Implement policies and procedures for authorizing access to PHI.

  • Access authorization process based on role and necessity
  • Access modification procedures when roles change
  • Regular access reviews and audits

Security Awareness and Training

Train all workforce members on security policies and procedures.

  • Initial training for new hires before PHI access
  • Annual refresher training for all staff
  • Security reminders about phishing, malware, and physical security
  • Password management and protection procedures

Security Incident Procedures

Implement policies and procedures to address security incidents.

  • Incident response plan with defined roles and responsibilities
  • Reporting procedures for suspected or known security incidents
  • Documentation and analysis of security incidents
  • Breach notification procedures (within 60 days of discovery)

Contingency Plan

Establish policies and procedures for responding to emergencies or disasters.

  • Data backup plan with regular backups and off-site storage
  • Disaster recovery plan to restore PHI access
  • Emergency mode operation plan for critical business processes
  • Testing and revision procedures (annual testing minimum)

Business Associate Agreements

Ensure vendors and partners who access PHI sign compliant agreements.

  • Written contract or agreement with all business associates
  • Specify permitted and required uses of PHI
  • Ensure business associates implement appropriate safeguards
  • Report security incidents and breaches to covered entity
Section 2

Physical Safeguards

Physical measures, policies, and procedures to protect electronic information systems and related buildings and equipment from natural and environmental hazards and unauthorized intrusion.

Facility Access Controls

Limit physical access to electronic information systems and facilities.

  • Procedures for granting facility access (badge systems, keys)
  • Visitor sign-in and escort procedures
  • Maintenance records for repairs and modifications to physical components

Workstation Use

Specify proper functions of workstations that access PHI and physical surroundings.

  • Policies for workstation location and physical safeguards
  • Screen privacy filters in public areas
  • Automatic screen locks after period of inactivity

Workstation Security

Implement physical safeguards for workstations that access PHI.

  • Cable locks for laptops in semi-public areas
  • Restricted access to areas with workstations containing PHI

Device and Media Controls

Implement policies and procedures for disposal, reuse, and removal of PHI-containing hardware and media.

  • Procedures for final disposal of PHI (shredding, wiping, destruction)
  • Procedures for removing PHI before reusing equipment
  • Inventory and accountability for hardware and media movements
  • Backup media secured with encryption and access controls
Section 3

Technical Safeguards

Technology and policies and procedures for its use that protect PHI and control access to it.

Access Control

Implement technical policies and procedures to allow only authorized access to PHI.

  • Unique user identification (no shared accounts for PHI access)
  • Emergency access procedures for PHI during crisis situations
  • Automatic logoff after predetermined time of inactivity
  • Encryption and decryption of PHI during transmission and at rest

Audit Controls

Implement hardware, software, and procedural mechanisms to record and examine access to PHI.

  • Log all PHI access attempts (successful and unsuccessful)
  • Regular review of audit logs for suspicious activity
  • Centralized logging system with tamper-proof storage

Integrity

Implement policies and procedures to ensure PHI is not improperly altered or destroyed.

  • Mechanisms to authenticate PHI hasn't been altered
  • Version control and change tracking for PHI modifications

Person or Entity Authentication

Implement procedures to verify that persons or entities seeking access to PHI are who they claim to be.

  • Multi-factor authentication for remote access to PHI
  • Strong password requirements (minimum 12 characters, complexity)
  • Biometric authentication for high-security areas

Transmission Security

Implement technical security measures to guard against unauthorized access to PHI being transmitted over electronic networks.

  • Encryption for all PHI transmitted over public networks (TLS 1.2+)
  • Secure VPN for remote access to internal systems
  • Email encryption for PHI sent via email
Section 4

Massachusetts-Specific Health Research Requirements

Additional compliance requirements for Massachusetts healthcare and research organizations.

MA

Massachusetts Data Privacy Law (201 CMR 17.00)

Additional requirements for protecting Massachusetts resident data.

  • Written information security program (WISP) required
  • Encryption of all personal information stored or transmitted
  • Secure authentication protocols for accessing personal information
MA

Research-Specific Compliance

Requirements for Massachusetts biotech and clinical research facilities.

  • IRB protocol compliance for human subject research
  • FDA 21 CFR Part 11 compliance for electronic records and signatures
  • NIH grant compliance requirements (data management plans)
  • Lab equipment data integrity and secure connectivity
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