If you’ve interacted with any health-related service in the last 20-plus years, you’ve heard of HIPAA. For companies working in or with the healthcare industry, compliance with HIPAA is the cornerstone of a strong security posture. Are you in tune with what it takes to gain and maintain HIPAA compliance? Why is HIPAA so important, and who needs to be HIPAA compliant? And what happens if an organization isn’t compliant with HIPAA? Read on for answers to these questions.
Let’s start from the top: What is HIPAA?
HIPAA stands for the Healthcare Insurance Portability and Accountability Act, which was signed into law on August 21, 1996. HIPAA’s high-level goal is to keep patients’ protected health information (PHI) — any individually identifiable health information — safe and secure, whether it exists in a physical or electronic form. HIPAA was passed to improve the portability and accountability of health insurance coverage for employees moving between jobs; its other goals include providing coverage for employees with pre-existing medical conditions and simplifying the administration of health insurance. If your company works in the healthcare industry or is considering working with healthcare clients, it is important to have an understanding of HIPAA and how to stay compliant with its requirements.
HIPAA applies to organizations known as covered entities and business associates. Covered entities include health care providers like doctors, clinics, psychologists, and more; health plans like health insurance companies and government healthcare programs; and health care clearinghouses that process health information. Business associates are people or entities performing activities that involve the use or disclosure of protected health information on behalf of or in service to a covered entity. Business associates could include third party administrators assisting a health plan with claims processing, SaaS healthcare solutions such as telemedicine technologies and mobile health apps, and more.
Why is HIPAA so important?
Before HIPAA was instituted, there was not a common set of accepted security standards or requirements for the protection of health information in the healthcare industry. HIPAA put in place requirements to ensure that healthcare organizations are actively safeguarding patient data — and also instituted repercussions for those organizations that fail to comply with HIPAA.
Technologies have evolved — and continue to evolve — in the years since HIPAA took effect. Over time, the healthcare industry as a whole has been moving away from keeping and collecting data and information on paper, moving instead toward using electronic information systems to conduct a wide range of industry functions, both in the clinical delivery of care and in its administration.
With more and more protected health information flowing through the many computerized systems and processes of covered entities and their business associates — from electronic health records and pharmacy and laboratory information, to computerized physician order entry (CPOE), by which healthcare providers use computers to directly enter medical orders — HIPAA compliance and the diligent protection of patient PHI only continues to increase in importance. New technology is always coming into play to manage and secure data in the healthcare industry; companies must be able to integrate and work with new technologies while maintaining the safety and security of patient PHI.
In order to ensure that your company is in compliance with HIPAA, your organization should build and implement a holistic data protection strategy that encompasses all areas of HIPAA compliance while ensuring the security and availability of PHI, and maintaining the trust of patients and those people and organizations with whom you do business.
What is HIPAA compliance?
There are a number of HIPAA rules that must be adhered to in order to ensure HIPAA compliance. The HIPAA Security Rule, instituted in 2005, is key among these rules, specifying safeguards to protect the confidentiality, integrity, and availability of electronic protected health information (ePHI). The Security Rule articulates three types of security safeguards — administrative, physical, and technical — that are required for a company to be in compliance with HIPAA.
- Administrative safeguards include a company’s performance of risk analysis as a part of their security management processes, e.g. evaluating the likelihood and impact of potential risks to ePHI, implementing security measures to address identified risks, documenting security measures to be taken, and maintaining continuous and appropriate security protections. Administrative safeguards also include designation of an official representative or team responsible for HIPAA security policies and procedures, implementing role-based access to ePHI, providing employee training, and regularly evaluating how a company’s policies and procedures are meeting the Security Rule.
- Physical safeguards include limiting and managing physical access to facilities while enabling authorized access, and implementing policies and procedures for access to and use of workstations and electronic media, as well as ensuring that policies are in place regarding transfer, removal, disposal, and reuse of electronic media, in order to protect ePHI.
- Technical safeguards include the implementation of ePHI access control policies, audit control mechanisms for the recording and examination of access and activity in systems interacting with ePHI, integrity controls to ensure and confirm that ePHI is not improperly altered or destroyed, and transmission security measures protecting against unauthorized ePHI access while ePHI is in transmission over a network.
In addition to implementing these safeguards for the protection of sensitive patient information, organizations working or interacting with patient PHI must now complete annual self-audits assessing their privacy and security practices to ensure that they are in line with current HIPAA standards, and should vet the vendors with whom they work.
Who needs to maintain compliance with HIPAA? And what happens if an organization is not in compliance?
The U.S. government passed the HITECH (Health Information Technology for Economic and Clinical Health) Act in 2009 to further encourage use of electronic health records; the HITECH Act also increased penalties for organizations in violation of HIPAA, and introduced the Breach Notification Rule. This rule requires that breaches of unsecured protected health information must be communicated to affected individuals, the U.S. Department of Health and Human Services (HHS), and in some cases, the media. As of 2020, HIPAA requires that breaches affecting fewer than 500 people, known as Minor Breaches, must be reported by the end of the calendar year to HHS and the affected individuals; while breaches affecting more than 500 people, known as Meaningful Breaches, must be reported within 60 days to HHS, the affected individuals, and the media. Meaningful Breaches reported to HHS are added to its Breach Notification Portal, a permanent archive and searchable database of HIPAA violations going back to 2009.
A data breach is not automatically a HIPAA violation; a HIPAA violation is defined as a failure to comply with HIPAA standards and provisions. If an organization’s compliance program compromises the security and integrity of PHI or ePHI, then the organization is in violation of HIPAA. Thus a data breach resulting from an incomplete or ineffective HIPAA compliance program becomes a HIPAA violation. Organizations in violation of HIPAA risk compromising sensitive patient information — and facing financial and other penalties as a result. Violations and data breaches can be extremely costly, from steep monetary fines to the costs of communicating breach notifications and mitigating subsequent damages, to the possibility of criminal prosecution.
Other recent HIPAA updates to be aware of
Recent HIPAA updates under consideration have included potential changes to HIPAA and related regulations with the goal of protecting the privacy of patients seeking treatment for substance abuse disorders; in the context of the opioid epidemic, there have been calls to make changes that would enable clinicians to view full medical records, including records related to substance abuse disorders, so that treatment decisions are informed by a patient’s full health history. With the passage of the Coronavirus Aid, Relief, and Economic Security (CARES) Act in 2020, healthcare providers’ ability to share records of individuals with substance abuse disorders has been expanded; at the same time, the CARES Act has tightened requirements around confidentiality breaches.
Vanta is here to help your company build a holistic security compliance program that will support your ongoing HIPAA compliance. Vanta provides a set of security and compliance tools that scan, verify, and secure a company’s IT systems and processes. Vanta also offers a suite of tools streamlining the non-technical components of security tracking and audit preparation, so that gathering, maintaining, and consolidating audit evidence is easier for both your company and your auditor. Vanta is “security in a box” for technology companies, trusted by hundreds for automated security and compliance.