HIPAA Compliance Requirements

HIPAA compliance requirements encompass a range of safeguards and standards that healthcare organizations must implement to protect the privacy and security of individuals’ protected health information (PHI), including administrative, physical, and technical safeguards, policies and procedures, risk assessments, employee training, breach notification, and business associate agreements. HIPAA compliance requirements are a comprehensive set of rules and regulations established by the Health Insurance Portability and Accountability Act (HIPAA) to safeguard individuals’ PHI. These requirements apply to healthcare providers, health plans, and healthcare clearinghouses, as well as their business associates who handle PHI. Compliance with HIPAA is crucial to ensure the privacy, security, and integrity of sensitive healthcare data. The compliance requirements cover various aspects of safeguarding PHI. First, administrative safeguards include the development and implementation of policies and procedures to govern the use, access, and disclosure of PHI, as well as workforce training and management. Physical safeguards involve the protection of physical assets that store or transmit PHI, such as facilities, workstations, and devices, through measures like access controls, facility security, and device encryption. Technical safeguards encompass the use of technology and security measures to protect electronic PHI, including access controls, audit controls, and encryption. In addition to these safeguards, HIPAA compliance requires conducting regular risk assessments to identify potential vulnerabilities and implementing appropriate risk management strategies to mitigate those risks. Compliance also entails having breach notification processes in place to promptly identify and report any unauthorized access, use, or disclosure of PHI. Furthermore, healthcare organizations must establish business associate agreements with their partners or vendors to ensure that they also adhere to HIPAA regulations when handling PHI. By adhering to these HIPAA compliance requirements, healthcare organizations can maintain the privacy and security of patient information, mitigate the risk of data breaches, and demonstrate their commitment to protecting sensitive healthcare data. Compliance with HIPAA not only helps to avoid legal penalties and financial repercussions but also builds trust with patients and strengthens the overall integrity of the healthcare system.

What is HIPAA Compliance?

HIPAA compliance, put simply, means acting in accordance with HIPAA and its associated Rules and Acts, such as the HIPAA Privacy Rule, the HIPAA Security Rule, The HIPAA Breach Notification Rule, the HIPAA Final Omnibus Rule, and the Health Information Technology for Economic and Clinical Health – HITECH –  Act. HIPAA compliance refers to the adherence and implementation of the rules and regulations outlined in the Health Insurance Portability and Accountability Act (HIPAA) to protect the privacy, security, and integrity of individuals’ protected health information (PHI) and ensure that healthcare organizations and their business associates meet the required standards for data privacy and security.

This is certainly quite a list of Rules and can seem intimidating. The complex nature of HIPAA is another area which some may find daunting. Compliance with HIPAA can be difficult to ensure due to the sometimes vague, sometimes very precise nature of the regulations. For our purposes, we will focus on some of the elements of the Privacy, Security, and Notification Rules that tend to cause the most confusion.

Risk, “Required”, and “Addressable” Specifications

Risk assessments that have been conducted by the organization to identify and categorize the risks they face must be documented. An area related to risk assessments that causes some confusion is the difference between required and addressable implementation specifications under the HIPAA Security Rule.

At its most basic level, this means that certain “required” features or elements are non-negotiable and must be implemented as described in the HIPAA text. There is typically sufficient detail in the law for organizations to clearly know whether they have met the necessary standard or not. “Addressable” specifications are not optional per se, but, as noted by the Department of Health and Human Services on their website, their purpose is to “provide covered entities additional flexibility with respect to compliance with the security standards”. This puts a certain responsibility on the covered entity as they “must decide whether a given addressable implementation specification is a reasonable and appropriate security measure to apply within its particular security framework”. The documented risk assessment study will allow organizations to determine what is prudent and applicable to their own situations. This also forms the explanation for decisions taken on addressable specifications, which can be provided to auditors on request.

Addressable specifications allow HIPAA to remain up-to-date without calling for continual revisions. Written legislation may be too slow to keep pace with technology and practices, but by requiring covered entities to take responsibility that their tools and procedures are in compliance with HIPAA, risks to PHI can be avoided.

The HIPAA Security Rule

Above, we mentioned the technical, physical, and administrative safeguards called for by the HIPAA Security Rule. Here, we examine these in more detail.

Technical safeguards relate to technology and how electronic protected health information (ePHI) is protected and accessed. HIPAA stipulates that ePHI that is stored or shared beyond an organization’s firewall is required to be encrypted to NIST standards. This means that any data that is intercepted would be unreadable, undecipherable and unusable. Organizations then must apply a range of addressable and required safeguards to other technical areas dealing with PHI, such as:

  • Implementing a means of access control (required)
  • Introducing a mechanism to authenticate ePHI (addressable)
  • Implementing tools for encryption and decryption (addressable)
  • Introducing activity audit controls (required)
  • Facilitating automatic logoff (addressable)

Where Technical safeguards deal mainly with the digital aspects, Physical safeguards are more related to real world security.  Among the physical safeguards are elements of facility access management, mobile devices, and workstation layout:

  • Implementation of facility access controls (addressable)
  • Development of policies relating to workstation use (required)
  • Development of policies and procedures for mobile devices (required)
  • Inventory of hardware (addressable)

Administrative safeguards cover the more day-to-day operational and procedural issues. Elements of the Security Rule and the HIPAA Privacy Rule are combined in the administrative safeguards. They also include provisions for Privacy and Security Officers to be appointed, risk assessments to be conducted, and other processes to be implemented. The administrative safeguards call for:

  • Conducting risk assessments (required)
  • Introducing a risk management policy (required)
  • Training employees to be secure (addressable)
  • Developing a contingency plan (required)
  • Testing the contingency plan (addressable)
  • Restricting third-party access (required)
  • Reporting security incidents (addressable)

The HIPAA Privacy Rule

The HIPAA Privacy Rule is a crucial component of the HIPAA that establishes national standards for protecting individuals’ medical records and other personally identifiable health information. The Privacy Rule applies to healthcare providers, health plans, and healthcare clearinghouses that electronically transmit health information. Its primary goal is to safeguard patients’ privacy rights by granting them control over their health information and limiting its use and disclosure without their authorization. The Privacy Rule mandates covered entities to implement safeguards to protect patient information, including administrative, physical, and technical measures. It requires covered entities to provide patients with notice of their privacy practices and obtain their written consent for certain uses and disclosures of their information. The Privacy Rule also grants individuals the right to access, request amendments to, and receive an accounting of their health information. Compliance with the Privacy Rule is essential for maintaining patient trust, ensuring confidentiality, and upholding the ethical responsibility of healthcare providers and organizations to protect sensitive health data. By adhering to the standards set forth in the HIPAA Privacy Rule, healthcare entities can uphold patient privacy, maintain legal compliance, and foster a culture of trust and respect in the healthcare industry.

The HIPAA Breach Notification Rule

As might be assumed from the title, this Rule relates to how and when parties are notified of breaches to PHI. In all cases, patients must be notified of breaches within 60 days of the discovery of a breach. The Department of Health and Human Services’ Office for Civil Rights (OCR) must also be notified, however a distinction is made between breaches affecting fewer or greater than 500 people, with more time being given for smaller breaches to be reported, something which may lead to confusion and further HIPAA violationsby healthcare organizations.

The Rule describes the information which must be included in breach notifications to patients, outlined here:

  • The nature of the ePHI involved
  • The unauthorized person who used the ePHI or to whom the disclosure was made (if known)
  • Whether the ePHI was actually acquired or viewed (if known)
  • By how much the risk of damage has been addressed or reduced

Mastering and ensuring compliance with these three Rules will go a long way to ensuring compliance with HIPAA as a whole. Covered entities should make note of the requirements set out by these Rules as the first steps in checking or designing  HIPAA compliance for their organization.