A Guide to Healthcare Compliance Regulations

Healthcare compliance is a broad term. In essence, it refers to an organization’s extensive efforts to ensure they have the relevant and appropriate measures, procedures, processes, and personnel to prevent fraud, waste, abuse, and misuse of any sort within the scope of their practice. It does so to ensure organizations meet the legal, professional, and ethical obligations placed upon them by various healthcare-related regulations.

Ensuring their patients’ personal medical information is appropriately stored, protected, used, and disposed of by implementing a strict data privacy infrastructure is one critical example of a medical professional or institution complying with their responsibilities per healthcare regulations.

As with any other industry, complete compliance is a matter of organizational reform rather than a concentrated tweak. The United States Sentencing Commission Guidelines Manual is a crucial resource still used by healthcare organizations today when designing their compliance programs. Though outdated, it laid out essential components such as the need for proactive preventive measures and assigning adequately qualified individuals at high-level positions with sufficient resources to ensure compliance.

With multiple healthcare regulations in effect simultaneously, organizations may find achieving complete healthcare compliance a formidable challenge. However, as is the case with any other organizational challenge, an organized plan with the right ethics, culture, technology, vision, and personnel is the only way forward.

Read on to learn more about various healthcare regulations your organization will likely be subject to, why compliance is so important, key challenges to be aware of, and perhaps most importantly, the best way to achieve healthcare compliance.

What Laws Regulate the Healthcare Industry?

As mentioned earlier, healthcare compliance is a reasonably broad concept. There are various regulations, federal and state, in effect at the same time, all requiring compliance. Which regulations each organization is subject to is a matter of extensive individual assessment, but here are some major ones all organizations are likely to be subject to:


The Health Insurance Portability and Accountability Act of 1996 (HIPAA) may well be the most well-known data privacy law in the United States. As a result of HIPAA, the HIPAA Privacy Rule and the HIPAA Security Rule were established. The Privacy Rule established national standards for the protection of certain health information. Similarly, the Security Rule established a set of security standards for protecting certain information that is maintained or transferred via electronic format.


The Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 exists to ensure the adoption and meaningful use of healthcare information technology. There are subtitles within the HITECH Act that deal with the electronic transmission of health information and the associated privacy, security, and operational risks. These provisions ultimately allow for the strengthening of the civil and criminal enforcement of the aforementioned HIPAA rules.


The Emergency Medical Treatment & Labor Act (EMTALA) was enacted back in 1986 as a means to ensure greater public access to emergency services regardless of their ability to pay for it.

Anti-Kickback Statute and Stark Laws

The Anti-Kickback Statute (AKS) ensures that no medical professional or institution offers any sort of financial incentives to patients in exchange for referrals. An example would be a medical professional offering their patients coupons or gift cards in exchange for bringing new customers to their institution.

The Physician Self-Referral Law or Stark Law ensures that no medical professional or institution can refer patients to receive “designated health services” from an entity that has a direct financial relationship with the professional or their immediate family. An example would be a medical professional prescribing their patients particular tests from a laboratory owned by the professional’s brother.


The Patient Safety and Quality Improvement Act of 2005 (PSQIA) is a reporting system designed to ensure an appropriate degree of data is available to be accessed to resolve any patient safety and health issues. Per PSQIA, patient safety organizations (PSOs) are to be shortlisted and allowed by the Agency for Healthcare Research and Quality (AHRQ) to collect and review patient safety information.

Why is Healthcare Compliance Important?

There are multiple reasons why healthcare compliance is such a critically important strategic and operational requirement for most medical professionals and institutions. For starters, there’s the legal aspect. Each healthcare regulation exists to improve patients’ experience and overall care in a particular aspect. Be it how their medical data is managed, how they receive medical treatment, and how no one unlawfully benefits from their medical needs.

As mentioned before, there are multiple healthcare-related regulations, each with its regulatory bodies. In such cases, healthcare compliance is a matter of complying with their legal obligations and avoiding the financial, reputational, and operational risks of non-compliance. In an area as volatile as healthcare, with few details can often be the difference between life and death. Any blemish on a medical professional or institution’s ability to ensure what’s best for their patients can bring lasting consequences.

Healthcare Compliance Requirements

That healthcare compliance is a tricky task would be a tremendous understatement. As mentioned earlier, simply understanding which regulations an organization is subject to and must comply with can be arduous, as multiple federal regulations overlap in terms of healthcare requirements. Add the fact that some multiple state-level laws and rules need to be followed simultaneously, and it’s clear why anything short of a comprehensively designed compliance program can spell disaster.

While each organization must carry out a thorough assessment of its own to gain better insights related to the best practices they need to implement to achieve healthcare compliance, here are a few steps every organization can undertake to build a reliable foundation for its compliance program:

  • Hire The Right Personnel – Hiring and promoting the right people for the appropriate roles within your organization can ensure healthcare compliance is achieved effectively and efficiently.
  • Automation Is Your Ally – Most of the tasks that have to do with an organization’s overall compliance, such as appropriately protecting patients’ data and only securely transferring them, can be automated, allowing for higher chances of overall compliance with better efficiency.
  • Rigorous Evaluations – Consistent assessments and evaluations of an organization’s internal processes, practices, and culture are vital in identifying and eliminating any possible flaws hindering its compliance efforts.

Challenges For Organizations and Providers

Regardless of the scale of an organization, healthcare compliance is a complex challenge owing to several factors. Not only are there a myriad of federal and state regulations, rules, and standards to follow, but these amalgam of laws are often highly diverse in nature.

Data privacy, tax obligations, hiring mandates, and a plethora of other aspects make up a slew of considerations a medical professional or institution must take into account when designing their healthcare compliance strategy. Remember, a concentrated effort in one department but the slightest neglect in others can undo the entire compliance program as a whole.

The best way to meet these challenges is not often clear as well since each organization is different, and owing to factors such as budget, operations, technology, and personnel, it is hard to have a “one-size fits all” approach to healthcare compliance.

However, the basics of a reliable and effective healthcare compliance program remain the same, as highlighted above. Hiring the right people, adapting to technological changes, and consistently assessing internal practices are the only ways an organization can gain actionable insights to aid its healthcare compliance plans.

How Securiti Can Help?

When it comes to healthcare compliance itself, it is a broad concept that requires medical professionals and institutions to comply with multiple regulations and requirements at the same time. A critical area of such requirements falls under the ethical and responsible management of patients’ sensitive and personal healthcare information.

While data privacy has risen in both urgency and importance over the past decade or so, patients’ healthcare information and their right to privacy related to it have always been a tremendously important facet, as reflected in the several healthcare regulations passed over the years.

As data has grown in both volume and breadth over the years, especially digitally, organizations face an uphill battle to continue adhering to healthcare compliance requirements.

This is where Securiti can help such organizations when it comes to appropriately dealing with their patients’ sensitive healthcare information. This is especially important in an area as dynamic and fluid as data privacy.

Thanks to its plethora of data privacy-centric products and solutions, Securiti empowers organizations to implement appropriate measures and mechanisms in place to protect its users’ personal and sensitive information appropriately.

Securiti’s Sensitive Data Intelligence (SDI) offers organizations the ability to find critical data assets in structured and unstructured data systems across on-premises and multi-cloud, classify & label all such data properly to implement appropriate security controls such as encryption and masking along with ensuring privacy metadata such as purpose and legal basis associated with each data asset are all properly cataloged.

Request a demo today and learn more about how Securiti can help you fulfill the data privacy aspects of your overall healthcare compliance program.

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