In the data privacy landscape, few terms carry as much weight or notoriety as “HIPAA Compliance.” However, for those outside of the healthcare sector or new to its data protection standards, the concept might seem opaque and intimidating. This post aims to demystify HIPAA Compliance, explaining what it is, what attaining it means, and its significance in the healthcare industry.
Firstly, let’s begin with the basics. HIPAA stands for the Health Insurance Portability and Accountability Act, enacted by the U.S. Congress in 1996. The primary objective of this legislation was to ensure that employees that may lose or switch jobs would not have their health insurance coverage affected for it, and so standards were set to safeguard the privacy and security of patients’ health information, especially as it pertains to electronic data communications and interchange. HIPAA Compliance, therefore, refers to the adherence to the regulations established under this Act. Any organization that deals with Protected Health Information (PHI), which includes details about an individual’s physical or mental health, provision of healthcare, or payment for healthcare, must be compliant with HIPAA standards or face an array of penalties. These organizations are broadly categorized into two terms: Covered Entities (CEs) and Business Associates (BAs). CEs include healthcare providers, health plans, and healthcare clearinghouses, while BAs are entities that perform certain functions or activities on behalf of, or provide specific services to, a CE that involve the use or disclosure of PHI.
To be HIPAA-compliant means an organization must meet several requirements stipulated over a number of rules and related acts. Let’s explore some of the key ones:
- Privacy Rule – The Privacy Rule requires the protection of all “individually identifiable health information” held or transmitted by a covered entity or its business associate, in any form, whether electronic, paper, or oral. This rule gives the patient rights over their health information, such as rights to examine and obtain a copy of their health records or to request corrections. Additionally, the rule provides guidance over when PHI may be disclosed and requires safeguards to be implemented to protect PHI such as designating a privacy officer and conducting user training.
- Security Rule – The Security Rule specifies a series of administrative, physical, and technical safeguards to ensure the confidentiality, integrity, and availability of electronic protected health information (e-PHI). These safeguards are designed to be flexible and scalable, allowing a covered entity to implement policies, procedures, and technologies that are suited to the entity’s size, organizational structure, and risks to consumers’ e-PHI. Of these safeguards, some are labeled as mandatory for direct implementation, and others are considered addressable where they may be adopted by alternate measures where appropriate.
- Breach Notification Rule – This rule requires covered entities and business associates to provide notification to affected individuals, the Secretary of Health and Human Services (HHS), and, in some cases, the media following a breach of unsecured PHI. These notifications must be provided without unreasonable delay and no later than 60 days following the discovery of a breach to affected individuals, and this notification should be concurrently extended to the HHS if the breach involves over 500 individuals, along with the media if 500 or more residents of a specific state are involved.
- Enforcement Rule – The Enforcement Rule contains provisions relating to HHS’ enforcement of the HIPAA Rules, and includes procedures for investigations, determination of violations, hearing rights, and the imposition of civil money penalties for violations of the HIPAA Rules. These penalties can range from $100 to $50,000 per violation (or per record), with a maximum penalty of $1.5 million per year for violations of an identical provision.
- HITECH Act – Although not technically a “HIPAA” rule, the HITECH Act is closely aligned with HIPAA and enhances it. The HITECH Act widens the scope of privacy and security protections available under HIPAA, and it increases the potential legal liability for non-compliance and provides for more enforcement.
- Omnibus Rule – Enacted in 2013, the Omnibus Rule is a set of final regulations modifying HIPAA in accordance with guidelines set in 2009 by the HITECH Act. It holds business associates to the same standards for protecting PHI as covered entities. It also expands patients’ rights, including the right to receive electronic copies of health information and to restrict disclosures to a health plan concerning treatment for which the individual has paid out of pocket in full.
To maintain compliance, an organization needs to maintain awareness of and compliance with these rules diligently. But the question of how exactly to comply can be complex, and finding a place to start is often challenging. Below are some critical areas that an organization should consider first as a starting point to ensure HIPAA compliance:
- Risk Analysis and Management – Conduct a thorough and accurate assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of PHI. This process should be systematic and ongoing, periodically reassessed to address changes in the organization’s practices or advancements in technology.
- Policies and Procedures – Develop and implement HIPAA compliant policies and procedures. This includes guidelines on handling, accessing, and disclosing PHI. Policies should cover areas like the use and disclosure of PHI, rights of individuals, administrative responsibilities, and breach notification processes.
- Training and Awareness – All workforce members, including employees, volunteers, and trainees, should be trained and aware of the HIPAA Rules and the organization’s policies and procedures. Additionally, a major goal is to foster a culture of compliance where employees understand the importance of protecting PHI and feel comfortable reporting potential issues without fear of retaliation.
- Regular Audits – Audits are essential to ensure that the organization is adhering to its policies and the HIPAA rules. These audits can help identify any gaps or areas of non-compliance and provide an opportunity to address these issues proactively. Regular audits can also serve as a way to monitor the effectiveness of the organization’s training and awareness programs.
- Incident Response – Even with thorough precautions taken, breaches can still occur. Hence, it is essential to have a robust incident response plan in place. This plan should outline the steps to be taken in the event of a breach, including identifying and containing the breach, assessing the impact, notifying the affected individuals and authorities, and taking steps to prevent future breaches. The plan should be reviewed and tested regularly to ensure its effectiveness.
Although the path to full HIPAA compliance can seem like an imposing process in terms of time and resources, it’s important to remember that the effort fulfills more than just meeting a regulatory requirement – it’s also about building trust with patients and clients. When an organization maintains compliance with exacting standards like HIPAA, it sends a message that it values and protects patients’ privacy and personal information. This trust can translate into stronger relationships with patients, improved reputation, and ultimately, better business outcomes.
Could you use additional guidance or steps to attain HIPAA Compliance? The analysts at CyberData Pros have extensive experience guiding organizations through the intricacies of HIPAA Compliance, including conducting comprehensive risk analyzes, auditing compliance status, training and more. Contact us today for a free consultation and to learn more about our services.