Health Data Privacy, Confidentiality, and Security Guidelines Development Toolkit

Introduction

This Health Data Privacy, Confidentiality, and Security Guidelines Development Toolkit was developed under the US President’s Emergency Plan for AIDS Relief Technical Assistance Platform to support countries to strengthen health data privacy, security, and confidentiality guidelines to protect individual patient privacy and facilitate exchange of health data for public health purposes consistent with national laws and policies. This toolkit has three components:

1. Health Data Privacy, Confidentiality, and Security Generic Guidelines
2. Health Data Privacy, Confidentiality, and Security Guidelines Implementation Framework
3. Health Data Privacy, Confidentiality, and Security Guidelines Implementation Assessment Plan

Toolkit Components

Generic Guidelines

The first component of the toolkit is a generic Guidelines document that includes a template. The template includes the basic sections that a health data privacy, confidentiality, and security guidelines document should include, along with a brief description of each section. The Generic Guidelines are not intended to be adopted as is; rather, the Implementation Framework must be applied to the template to ensure contextualization in a country context. The Generic Guidelines include a few key points in each section (marked “Important”) for consideration by stakeholders during development.

Guidelines Implementation Framework

This document is intended as a guide for implementing the Generic Guidelines, which serve as a template for countries to use to develop health data privacy, security, and confidentiality guidelines or to modify an existing policy/guideline.

This document is to be used in the following scenarios:

1. If a national government/program/project/organization does not have an existing health data privacy, confidentiality, and security policy or guideline and has identified a need to develop and implement one.
2. When a country/project has an existing policy or guideline document and needs a guide on implementation.

Guidelines Implementation Assessment Plan

The purpose of this assessment plan is to:

1. Documenting levels of Guidelines implementation
2. Assessing support and compliance with existing Guidelines
3. Identifying facilitators and barriers to implementation of Guidelines
4. Identifying unintended consequences of Guidelines
5. Identifying gaps in the content or substance of the Guidelines
6. Identifying effective Guideline implementation strategies to inform future implementation efforts
7. Providing accountability for resources invested