HIPAA Compliance Software: Policies, Templates, Checklist

The final HIPAA Security rule published on February 20, 2003, HITECH act of 2009, Omnibus rule of 2013 requires that healthcare organizations create policies and procedures to apply the security requirements of the law – and then train their employees on the use of these policies and procedures in their day-to-day jobs.

HIPAA rule has very specific requirements with regard to creating, implementing, or changing Policies and Procedures. “Standard: Policies and Procedures — A covered entity must implement policies and procedures with respect to protected health information that is designed to comply with the standards, implementation specifications, or other requirements of this subpart. The policies and procedures must be reasonably designed, taking into account the size of and the type of activities that relate to protected health information undertaken by the covered entity, to ensure such compliance. This standard is not to be construed to permit or excuse an action that violates any other standard, implementation specification, or other requirements of this subpart.”

We have developed 71 HIPAA security policies which include 60 security policies & procedures required by HIPAA Security regulation and additional 11 policies, checklist and forms as supplemental documents to the required policies. These policies meet the challenges of creating enterprise-wide security policies. The suite addresses all major components of the HIPAA Security Rule and each policy can be adopted or customized based on your organization’s needs.

I. Policies on the Standards for Administrative Safeguards

• Breach Notification Policy
• Security Management Process
• Risk Analysis
• Risk Management
• Sanction Policy
• Information System Activity Review
• Assigned Security Responsibility
• Workforce Security
• Authorization and/or Supervision
• Workforce Clearance Procedure
• Termination Procedures
• Information Access Management
• Access Authorization
• Access Establishment and Modification
• Security Awareness & Training
• Security Reminders
• Protection from Malicious Software
• Log-in Monitoring
• Password Management
• Security Incident Procedures
• Response and Reporting
• Contingency Plan
• Data Backup Plan
• Disaster Recovery Plan
• Emergency Mode Operation Plan
• Testing and Revision Procedure
• Applications and Data Criticality Analysis
• Evaluation
• Business Associate Contracts and Other Arrangements
• Business Associate Agreement
• Execution of Business Associate Agreements with Contracts

II. Policies on the Standards for Physical Safeguards

• Facility Access Controls
• Contingency Operations
• Facility Security Plan
• Access Control and Validation Procedures
• Maintenance Records
• Workstation Use
• Workstation Security
• Device and Media Controls
• Disposal
• Media Re-use
• Mobile Device Policy
• Accountability
• Data Backup and Storage

III. Policies on the Standards for Technical Safeguards

• Access Control
• Unique User Identification
• Emergency Access Procedure
• Automatic Logoff
• Encryption and Decryption
• Audit Controls
• Integrity
• Mechanism to Authenticate Electronic Protected Health Information
• Person or Entity Authentication
• Transmission Security
• Integrity Controls
• Encryption

IV. Organizational Requirements

• Policies and Procedures
• Documentation
• Isolating Healthcare Clearinghouse Function
• Group Health Plan Requirements

V. Supplemental Policies for Required HIPAA Policies

• Wireless Security Policy
• Email Security Policy
• Analog Line Policy
• Dial-in Access Policy
• Automatically Forwarded Email Policy
• Remote Access Policy
• Ethics Policy
• VPN Security Policy
• Extranet Policy
• Internet DMZ Equipment Policy
• Network Security Policy

A covered entity is required to develop and implement policies and procedures appropriate to the entity’s business practices and workforce that reasonably minimize the amount of protected health information used, disclosed, and requested;” – HIPAA Privacy Rule 45 CFR Part 160.

Following are the 57 policies, forms, and procedures included in the HIPAA Privacy Policy & procedures template suite. The policies can be used by any covered entity. All policies are available in MS Word format and can be easily modified as per your requirements. Each template is presented in a standard format reflecting critical organizational functions to consider in HIPAA remediation.

These HIPAA policies cover all the major areas like:

1. General policies regarding use and disclosure of PHI
2. Minimum necessary rule for use and disclosure of PHI
3. Patient rights regarding their own PHI
4. Uses and disclosures not requiring patient authorization
5. Special cases for restriction of uses and disclosures of PHI
6. Organizational issues and safeguards

The templates suite includes following HIPAA Privacy policies and procedures.

• Accept Access Request
• Accounting for Disclosures
• Acknowledgment of Receipt
• Amendment to Record Form
• Authorization for Release of Protected Health Information
• Authorization To Use Disclose Protected Health Information
• Business Associate Agreement
• Business Associate Contracts and Other Arrangements
• Complaint Process
• Data Use Agreement Template
• De-identified Information and Limited Data Sets
• Denial Access Request
• Denial Request to Amend Form
• Disclosure Accounting Log for Medical Information
• Disclosure of PHI with and without authorization Template
• Disclosures Record Form
• Document Retention Requirements
• EHR accounting of disclosures
• Employee Confidentiality Agreement
• Execution of Business Associate Agreements with Contracts
• Health Plan Notice of Privacy Practices
• HIPAA Accept Amend Request Form
• Identifying PHI and Designated Record Sets
• Minimum Necessary
• Multi-Organization Arrangements
• Notice of Privacy Practices
• Patient Right to Access PHI
• PHI Release by Whistleblowers
• Privacy Officer
• Receipt of Payment when Disclosing PHI
• Release for Abuse Neglect or Domestic Violence
• Release for Confidential Communications
• Release for Fundraising Purposes
• Release for Health Oversight
• Release for Judicial or Administrative Proceedings
• Release for Law Enforcement
• Release for Marketing Purposes
• Release for Public Health
• Release for Research Purposes
• Release for Specific Government Functions
• Release for Workers Compensation
• Release of Information for Deceased Patients or Plan Members
• Release of Information for Legal Representatives
• Release of Information to a Minor
• Release of Information to a Minor’s Parents
• Release of Information to Friends and Family Members
• Release of Psychotherapy Notes
• Release to Patient or Plan Member
• Release to Avert Serious Threat to Safety
• Request Confidential Communications Template
• Request Restriction
• Request to Amend Patient or Plan Member Record
• Requests for Restriction policy
• Required PHI Disclosures
• Right to Object to Release for Certain Purposes
• Safeguarding PHI
• Training Requirements
• Workforce Sanctions

Risk Analysis is often regarded as the first step towards HIPAA compliance. Risk analysis is a required implementation specification under the Security Management Process standard of the Administrative Safeguards portion of the HIPAA Security Rule as per Section 164.308(a)(1). Covered entities will benefit from an effective Risk Analysis and Risk Management program beyond just being HIPAA compliant. Compliance with HIPAA is not optional… it is mandatory, to avoid penalties.

Objective of HIPAA Security Risk Analysis/Assessment:

The overall objective of an HIPAA risk analysis is to document the Potential risks and vulnerabilities to the confidentiality, integrity, or availability of electronic protected health information (ePHI) and determine the appropriate safeguards to bring the level of risk to an acceptable and manageable level. It helps in ensuring that controls and expenditure are fully commensurate with the risks to which the organization is exposed.

List of documents in HIPAA Security Risk Analysis Template revised for HITECH Omnibus Rule

• Asset Inventory Worksheet
• Detailed HIPAA Security Risk Analysis Executive Report
• Risk Analysis Checklist
• Risk Analysis Template
• Risk Assessment Executive Presentation
• HIPAA Security Risk Assessment Scorecard
  • Overview spreadsheet
  • Administrative safeguard spreadsheet
  • Technical safeguard spreadsheet
  • Physical safeguard spreadsheet
  • Organizational safeguard spreadsheet
• Sample Privacy & Security Risk Analysis Executive Report 2013-Short Version
• Threat Matrix Worksheet

The HIPAA Security Rule requires organizations, at a minimum, to conduct periodic internal audits to evaluate processes and procedures intended to secure confidentially or “protected health information” (PHI) (45 CFR 164.308(a)(8)). It is often advisable to seek an external review or audit but the provisions of the security rule do not specifically require this. In most cases, this will be determined by the size of the organization, line of business, and, sometimes, contract requirements (i.e., Medicare, Medicaid, etc.). The purpose of the audit is to determine if an organization has properly documented administrative, physical and technical security practices, policies, and procedures and generally meets the requirements of the rule.

Objective of HIPAA Audit and Evaluation for Compliance

The objective of HIPAA Audit includes the following activities:

• Assess if all vulnerabilities have been addressed.
• Verify that all compliance requirements have been met.
• The objective of the Audit Control standard is to implement hardware, software, and/or procedural mechanisms that record and examine activity in information systems that contain or use electronic protected health information.

List of documents for HIPAA Audit Template:

• HIPAA Comprehensive Audit Checklist
• HIPAA Privacy & Security Audit Report – Sample
• HIPAA Security Abbreviated Audit Checklist final
• HIPAA Security Audit Executive Presentation
• Information Security Audit Template