$16 million—that’s the highest HIPAA non-compliance penalty to date, paid by Anthem Inc., one of the largest health benefits companies in the US. In 2015, cyber-attackers exploited Anthem’s insufficient access control procedures, stealing the ePHI of nearly 79 million policyholders.

In a more recent healthcare data violation, a 2022 ransomware attack targeted at a printing and mailing vendor, OneTouchPoint, affected 34 healthcare organizations that were the company’s customers. As a result, records of over 2.5 million people were compromised.

These and dozens of other cases each year share the same root cause: non-compliance with safety measures required by acts such as HIPAA or the HITECH Act. Exorbitant penalties aside, failing to adhere to the increasingly complicated healthcare regulations entails risks much more severe than financial losses.

Luckily, with the help of RPA-based compliance automation, meeting legal requirements is more effortless than ever. Why? And what regulations are these? You’ll find it out in a moment—welcome to our overview of the most critical healthcare-related regulations in the US and how RPA can help you meet them.

Why is healthcare compliance important?

Despite the million-dollar fines and all the talk about the importance of compliance, healthcare data breaches had been on a 14-year rise until a slight decrease in 2022. So, before discussing regulations, let’s see what makes following them vital.

Security breaches

While the large cases involving millions of policyholders get the most media coverage, they are far from the only ones. The US Department of Health and Human Services’ Office for Civil Rights (OCR) reports hundreds of healthcare regulation breaches yearly, with an all-time high of 715 in 2021 alone.

Costly fines

Settlements and monetary penalties cost healthcare organizations millions of dollars each year. Just in 2023, non-compliance fines amounted to more than $3 million, which is still relatively small compared to most previous years.

Lower patient care quality

Financial losses resulting from non-compliance can severely disrupt the operational capabilities of your healthcare organization. Lower funds mean reduced investments, fewer equipment upgrades, discontinued services, and even layoffs.

Patient distrust

Though eroding trust can’t be measured with numbers, it’s the ultimate consequence of non-compliance. The blow to reputation following a sensitive data breach is hard to recover from, leading to further financial losses.

Legal Requirements in the US Regarding Compliance

As healthcare and data technologies developed, many policies were implemented to ensure healthcare services’ efficiency and protect sensitive information. Today, multiple laws regulate healthcare data sharing and safeguarding in the US. Here are some of the most essential ones.

Health Insurance Portability and Accountability Act (HIPAA)

The most well-known healthcare data regulation, HIPAA, was established in 1996 to govern the use and sharing of patient records in all formats, whether verbal, written, or electronic. Under HIPAA, the Department of Health and Human Services (HHS) sets boundaries on using and sharing health information, safeguards to protect patients’ records, and penalties for violations.

Eventually, additional rules were established to build on HIPAA. The HIPAA Privacy Rule introduced nationwide standards for securing, using, and sharing PHI, and it outlines how entities can use these records without a patient’s explicit authorization. It also gives patients control over their information, including the right to examine, obtain, and issue copies of their health records and to request necessary corrections.

HIPAA Security Rule puts these standards into action, requiring providers to assess risk and then implement appropriate administrative, physical, and technical measures to keep electronic PHI (ePHI) safe.

Who does HIPAA apply to?

Health Information Technology for Economic and Clinical Health Act (HITECH)