In our global, digital world, the protection of sensitive information is of the utmost importance. In the United States, the Health Insurance Portability and Accountability Act (HIPAA) is the federal law that directed the Department of Health and Human Services (HHS) to establish regulations to safeguard protected health information (PHI). HIPAA was enacted on August 23, 1996.1
Compliance with the regulations that HHS published in response to HIPAA (the “HIPAA regulations”) is a legal requirement for organizations operating in the health care industry. In this blog post, we will delve into what HIPAA compliance entails, its importance, and the steps that organizations need to take to ensure they remain compliant.
What is HIPAA?
HIPAA has been the touchstone of U.S. health privacy for nearly 30 years. The primary objectives of HIPAA are to ensure the confidentiality, integrity, and availability of PHI while promoting the portability of health insurance coverage.
To support the aims of the law, there are five sections, or titles, outlined in the act.2 Title II is entitled “Preventing Health Care Fraud and Abuse; Administrative Simplification; Medical Liability Reform of HIPAA,” and is the title most often implicated by privacy concerns by healthcare organizations.
The Department of Health and Human Services (HHS) has implemented its HIPAA regulations as directed by HIPAA by publishing five rules which drive HIPAA compliance. These are:
- Privacy Rule
- Transactions and Code Sets Rule
- Security Rule
- Unique Identifiers Rule
- Enforcement Rule
Here, we will take a closer look at the Privacy Rule and the Security Rule.
The Privacy Rule, which was published December 28, 2000, sets standards for the protection of PHI and governs its use and disclosure by covered entities.1 Covered entities are defined as healthcare providers, health plans, and healthcare clearinghouses.3 Overall, the aim of this rule is to simultaneously protect individuals' health information while allowing necessary health information to be shared in order to provide and promote high quality health care.1 The Privacy Rule also grants patients certain rights, including the right to access and request corrections to their health information.
The Privacy Rule defines what entities are covered, what information is protected, and provides guidelines for use and disclosures. To be in compliance, professionals and entities handling PHI must follow the established set of national standards to use and disclose health information.
The Security Rule was published February 20, 2003 and focuses on safeguarding electronic protected health information (ePHI).4 As such, the Security Rule aims to extend the application of the Privacy Rule to PHI that is increasingly created and used in electronic formats.4
The Security Rule requires that covered entities implement technical, physical, and administrative safeguards to protect ePHI.5 Safeguards include measures such as access controls, encryption, and regular security risk assessments. To implement effective safeguards, the Security Rule requires covered entities to perform risk analysis and management.4 This provision is essential to the rule, as it requires organizations not only implement effective policies and safeguards, but also review and adjust them on a regular basis.
Why is HIPAA Compliance Important?
Covered entities’ compliance with HIPAA regulations is important for numerous reasons. First and foremost is protecting patients’ privacy and confidentiality. Compliance with HIPAA regulations helps organizations establish robust security measures, thereby reducing the risk of data breaches and unauthorized access to PHI.
Furthermore, HIPAA compliance safeguards health organizations from legal and financial penalties. Compliance violations can lead to significant fines, ranging from thousands to millions of dollars, depending on the severity of the breach and the organization’s response. Compliance is crucial for avoiding these penalties and preserving the financial stability of health care organizations.
What are the Requirements for HIPAA Compliance?
There are several steps that companies should take to achieve and maintain compliance.
Develop and Implement Policies and Procedures
In order to achieve and maintain compliance, organizations and compliance professionals must develop and implement the required policies and procedures. These include comprehensive policies and procedures that outline how PHI is handled, accessed, and disclosed. Policies should address the Privacy Rule and Security Rule requirements, as well as provide guidance on breach notification procedures and patient rights.
Train and Educate Employees
After policies and procedures are established, all employees involved in handling PHI need to be educated and trained. Properly educating employees about HIPAA regulations is an essential step for compliance. Organizations should provide training programs to ensure that employees understand their responsibilities, know how to handle PHI securely, and are aware of the potential consequences of non-compliance.
Ensure Third-Party Compliance
Another required step to maintaining compliance is ensuring that any third-party vendors the organization works with are also in compliance with HIPAA. These third-party vendors are considered business associates under HIPAA, and covered entities must have business associate agreements (BAA) with these organizations. In a BAA, the business associate agrees to maintain HIPAA compliance while handling PHI. Furthermore, the BAA provides that a business associate must implement its own BAA if it decides to contract with another third-party vendor, thereby ensuring that PHI is never exchanged with an actor not bound to HIPAA compliance.
Conduct Regular Audits, Reviews, and Assessments
Once the required policies and procedures are established, organizations must conduct regular audits and reviews to help identify vulnerabilities and areas for improvement regarding HIPAA compliance. This review process should include technical risk assessments and reviews of existing contractual agreements regarding HIPAA. Any gaps in processes or agreements should be addressed promptly to ensure ongoing adherence to regulations.
Step Up to Lead in Health Care Compliance
Health care compliance professionals play an essential role in maintaining compliance with HIPAA regulations. As the healthcare industry continues to evolve, staying up-to-date with HIPAA compliance is crucial for success. Earning a Master of Studies in Law (MSL) with a Health Care Compliance specialization from Pitt Law, will help you master the ins and outs of health care compliance that you need to gain more authority and responsibility in your career. And, if you are not interested in earning a full master’s degree, you can check out the Health Care Compliance Certificate program.
Set yourself up to be a leader in health care compliance. Graduates of Pitt Law's Health Care Compliance Certificate or MSL program who have fulfilled the applicable requirements may be eligible to sit for industry exams, including:
- Certified in Healthcare Compliance (CHC)®
- Certified in Healthcare Research Compliance (CHRC)®
- Certified in Healthcare Privacy Compliance (CHPC)®
- Certified Compliance & Ethics Professional (CCEP)®
- Certified Compliance & Ethics Professional–International (CCEP-I)®
- Retrieved on May 26, 2023, from hhs.gov/hipaa/for-professionals/privacy/laws-regulations/index.html
- Retrieved on May 26, 2023, from ncbi.nlm.nih.gov/books/NBK500019/
- Retrieved on June 14, 2023, from govinfo.gov/content/pkg/CFR-2009-title45-vol1/pdf/CFR-2009-title45-vol1-sec160-103.pdf
- Retrieved May 26, 2023, from hhs.gov/hipaa/for-professionals/security/laws-regulations/index.html
- Retrieved June 14, 2023, from ihs.gov/sites/privacyact/themes/responsive2017/display_objects/documents/PvcFR01.pdf