What is a Privacy Impact Assessment?

PIAs are a broader federal requirement for assessing privacy impacts across various federal initiatives and systems. For entities falling under both mandates, the PIA process helps address privacy risks related to health information in compliance with HIPAA's Privacy Rule.

What is a Privacy Impact Assessment?

A Privacy Impact Assessment (PIA) is a systematic evaluation process required by the Electronic Government (E-Gov) Act of 2002 and further clarified in OMB Memorandum. The purpose of a PIA is to analyze and assess the potential privacy impacts of new initiatives, information technology systems, third-party websites and applications, and surveys that collect personally identifiable information (PII) or sensitive information. 

The PIA must be completed before an IT system becomes operational, a Third-Party Websites and Applications (TPWA) account is created, or a survey is launched. It involves analyzing how information is handled, determining risks and effects of collecting and disseminating information in identifiable form, and evaluating protections and alternative processes to mitigate potential privacy risks.

See also: How to perform a risk assessment

HIPAA and the PIA

HIPAA requires healthcare providers, health plans, and others handling protected health information (PHI) to perform Privacy Impact Assessments (PIAs) for new IT systems or technologies. This helps them assess potential privacy risks and ensure compliance with HIPAA's Privacy Rule. Business associates, who handle PHI on behalf of covered entities, must also conduct PIAs to align with their contractual obligations and the federal PIA requirement. Federal agencies like HHS and NIH must follow both HIPAA and PIA requirements, necessitating PIAs for their IT systems, TPWAs, and surveys involving PHI, while ensuring adherence to HIPAA regulations.

How a PIA is performed

The PIA begins by identifying the scope and purpose of the assessment, including the specific data collection and processing activities involved. It involves conducting a thorough data inventory and mapping exercise to understand the flow of personal information throughout the initiative's lifecycle. The assessment then examines the initiative against privacy principles and relevant legal and regulatory requirements to ensure compliance. 

Privacy risks are identified, and appropriate privacy controls and mitigation strategies are developed and implemented to address them. Stakeholder consultation, documentation, and approval are necessary steps in the process. Privacy by design principles are integrated from the outset, and regular review and monitoring are conducted to maintain privacy compliance.

See also: The basics of HITECH and how it works with HIPAA

Areas in healthcare organizations impacted by a PIA

1. Health information types: Identify the specific types of health information that will be collected, processed, and stored, such as medical records, diagnostic results, treatment plans, mental health data, genetic information, and other sensitive health data.
2. Electronic health record (EHR) systems: Assess the privacy implications of implementing or upgrading Electronic Health Record (EHR) systems, as these contain comprehensive patient information accessible by multiple healthcare providers.
3. Health data sharing: Consider how health data will be shared with other healthcare entities, third-party vendors, or research institutions, ensuring compliance with HIPAA's Privacy Rule and applicable data sharing agreements.
4. Research and clinical trials: Evaluate the privacy risks associated with participation in research studies and clinical trials, particularly when sharing de-identified or limited data sets.
5. Telemedicine and remote care: Analyze the privacy impacts of telemedicine and remote care services, including video consultations, remote monitoring devices, and data transmission.
6. Patient portals and mobile apps: Assess the privacy risks associated with patient portals and mobile applications that allow patients to access their health information remotely.
7. Healthcare Internet of Things (IoT) devices: Consider the privacy implications of using IoT devices in healthcare settings, such as wearables, medical sensors, and smart medical devices.
8. Health information exchange (HIE): Evaluate the privacy risks when exchanging health information with other healthcare providers through Health Information Exchanges.
9. Healthcare data analytics: Analyze the privacy implications of using data analytics tools to process health data for quality improvement, population health management, and research purposes.
10. Patient consent and authorization: Address patient consent and authorization for data sharing, treatment, research, and other uses of health information.
11. Emerging technologies: Stay informed about emerging technologies and their potential privacy implications in the healthcare industry.

See also: HIPAA Compliant Email: The Definitive Guide