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Regulatory Compliance Standards for Healthcare SaaS Solutions in Different Countries

Vlad Vakser Vlad Vakser | December 27, 2020 | 10 min

Law has developed guidelines for every aspect of our lives, and no niche can escape them. Every business has its standards and rules that they have to obey. Especially the governmental structures such as healthcare organizations have one of the strictest regulations that are severely checked. There are guidelines on billing, patient care, reimbursement, and many other spheres. While technology is an integral part of the healthcare system, more and more concerns and regulations are imported into the IT aspect.  

If you do not want to unintentionally break a regulation or two, this article is a must-read. You will get to know more about regulatory compliance standards for healthcare SaaS solutions, why you should keep these standards in mind, and a variety of standards across different countries.  

What Are Regulatory Compliance Standards for Healthcare Saas Solutions?  

Regulatory compliance standards dictate what is legal and illegal and how things should work in a way where nobody is harmed. When it comes to healthcare regulatory compliance for SaaS solutions, it is mostly about data and privacy security.   

Overall, people are bringing the issue of privacy and data security more and more up as IT develops, especially with cloud services growing popular. Files in the cloud are very susceptible to various cyber-attacks, as even while being encrypted the data can still be intercepted on the route to its destination. Moreover, many people feel like they are being watched all the time and the data breaches do not make them feel any safer. Some even refuse to share any private information at all, and while electronic healthcare records, for example, are much easier, they want paper ones back.  

Governments around the world are issuing strict cloud computing laws and regulations in healthcare industry. There have been so many lately that it is quite hard to keep up with regulatory compliance for healthcare SaaS solutions.   

Why Is It Essential to Follow Regulatory Compliance in Healthcare?  

Even though it is hard to keep up with all the rapidly changing cloud security regulations, you still have to be updated about all the regulatory requirements for SaaS solutions in the medical field. Healthcare is a very regulated system, and many organizations are trying to fix all the issues before the government finds out and fixes it themselves. Why so? Is it important to follow regulatory compliance requirements for healthcare just because the government requires you to do so?   

Shift toward Patient-Centered Care 

First, improving patient care is the primary goal of regulatory compliance. Standards and rules are developed so that every patient gets equally good care and fraud is avoided. After all, healthcare is about saving people’s lives and if some rules are broken, it can lead up to someone’s death. No country in the world would like its citizens to be treated poorly with consequent health problems so they try to regulate every aspect of it.   

Considering how much sensitive information is shared with healthcare units, it is not surprising that there are so many data protection laws in healthcare of the world. If a medical record ends up on the darknet, it will result in identity theft and emotional harm to the individual. Consequently, a data breach in healthcare is the most expensive: it costs $7,13 million, with the average costs within other industries being around $4 million.  

Avoid Fines  

Secondly, the fines for breaking patients’ privacy due to unreliable SaaS solutions are too big to handle, as for a healthcare organization in the USA financial penalties can reach up to $1,5 million. What if the breach happens more than once? It is easier to implement better SaaS than pay big amounts of money every time when the software did a bad job.   

In order to avoid fines, healthcare entities should be aware of the difference between regulatory and compliance risks. Compliance risk is the exposure to legal and financial penalties that an organization would face if not adhering to all the regulations. On the other hand, regulatory risk is a possibility that a change in the regulation would negatively affect the company’s operation. Organizations need to pay attention to both not to suffer financial losses now and to avoid them in the long run.    

It is obvious now that following the compliance standards is beneficial to both patients who will get better treatment and healthcare units that will avoid fines, additional costs, and governmental punishments.   

Do you want to ensure the regulatory compliance of your software?
Contact now!

Differences in Regulatory Compliance Standards for Healthcare SaaS Solutions by Countries

Countries take patient privacy and cyber security in healthcare seriously. We made a list of global data privacy laws for healthcare SaaS projects that you must know and follow, so let’s closely discuss each of them. 

Health Insurance Portability and Accountability Act (HIPAA) 

  • Country: the United States 

About HIPAA 

These security controls are widely used in the United States. It is supervised by the Health and Human Services Department (HHS). HIPAA puts particular emphasis on securing ePHI and ensuring privacy while using electronic health records (EHR).   

Healthcare HIPAA compliance clearly identifies what data should be protected. Those are 18 PHI identifiers that include names, SSN, zip code, etc. Although the information about regulation requirements is very precise, it is easy to unintentionally break rules while developing a HIPAA compliant document management software. So we made a list of HIPAA compliance software requirements that would help you create a cloud-based SaaS that satisfies all of the IT regulatory compliance standards in healthcare: 

  • User authorization;  
  • Access control;  
  • Authorization monitoring;  
  • Data backup;  
  • Remediation plan;  
  • Emergency mode;  
  • Automatic log off;   
  • Data encryption and decryption.  

If the medical organizations meet SaaS healthcare HIPAA compliance, they can move their records, pharmacy, radiology, and laboratory systems online while still maintaining privacy.   HIPAA

Penalties for Violation 

The amount of financial penalty for non-compliance depends on the level of negligence and ranges between $100 to $50,000 per one violation. The fine can reach up to $1.5 million per year for violations of an identical provision

HIPAA Violation Case 

In 2018, a medical imaging service provider based in Tennessee paid $3 million in penalties because of violating multiple HIPAA rules. The FBI found out that their services were easily accessible on the Internet disclosing ePHI for over 300,000 patients of various healthcare entities. In addition to that, they didn’t notify the affected individuals about the data leakage for 147 days.  

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

  • Country: the United States 

About HITECH  

HITECH is a US-based regulation as well. It can be seen as complementary to the HIPAA. However, it has a strong focus on electronic health records. Unlike HIPAA, the regulation is about IT-sphere only. HITECH clearly defines criminal and civil compliance penalties. They are based on factors of willful neglect and resolving the timeline.  

Although HIPAA and HITECH seem to be very similar, there’s a difference between them with regard to patients’ rights. Prior to the enforcement of HITECH, patients could find out who had accessed their ePHI. After the appearance of HITECH, patients have gained the right to request the report of whom their personal information had been disclosed to and under what authority. HITECH

Penalties for Violation 

Fines can go up to $1,5 million. 

HITECH Violation Case  

In 2019, a Kansas-based Coffey Health System needed to pay $250,000 to the U.S. for lying about EHR Security. From 2012 through 2019 Coffey County Hospital has been submitting false security risk attestations in order to be eligible for HITECH payments. After the investigation, the fine has been imposed because providers who fail to ensure the security of EHR must be responsible for that.  

Office of the Australian Information Commissioner (OAIC)  

  • Country: Australia

About OAIC 

Regulation is important for Australia as well. OAIC defines how patients’ information should be collected, stored, and disclosed. The main points highlighted in the document are that patients should have full control over their sensitive data and healthcare facilities should provide complete network security and immediately report any data breaches. 

OAIC developed a well-built guide to health privacy, provides a privacy action plan for healthcare units, and has a data breach management plan.  OAIC

Penalties for Violation 

Penalties include imprisonment up to two years or 600 penalty units or a fine of AUS 2,1 million. 

OAIC Violation Case 

The OAIC’s quarterly report had revealed the vulnerability of the private health sector to data breaches. While not exposing details of the origin of privacy violation, the report showed that around 5,000 individuals were affected during each of the three biggest data breaches in the health sector. 

Personal Information Protection and Electronic Documents Act (PIPEDA)  

  • Country: Canada 


This regulation is valid for Canada. It is quite similar to HIPAA but has more aspects covered. For example, it also requires data protection in medical apps which is not the case for HIPAA.PIPEDA

Penalties for Violation

The company that has breached the PIPEDA requirements can be fined up to $100,000 for each case of violation. 

PIPEDA Violation Case  

According to statistics, more than 680 breaches have been reported by businesses that are subject to PIPEDA within a period of one year. The fact that over 28 million Canadians have been affected by these breaches reveals the challenges faced by the Canadian government.

General Data Protection Regulation (GDPR) — The European Union  

  • Country: the EU countries 

About GDPR 

GDPR is applicable within the EU. It broadens the definition of sensitive data, adding IP addresses and biometric and genetic data, racial and ethnic origin and religion, allows individuals to delete their data, and withdraw their consent of data collection any time they want.GDPR

Penalties for Violation 

Fines are serious and can go up to 10 million euros. 

GDRP Violation Case 

In 2019 a Dutch Haga Hospital was penalized with a €460,000 GDPR data breach fine because the record of a well-known Dutch person has been viewed by several employees without authorization. The GDPR investigation also revealed that the healthcare unit failed to implement quality security control, didn’t have two-factor authentication in place, and monitor log files to detect unauthorized data access. 

Our Experience  

Langate cooperated with Verified Clinical Trials to help them create a system that adheres to all HIPAA and GDPR requirements. VCT is an innovative SaaS clinical trials solution that prevents dual enrollment. It serves numerous pharmaceutical sponsors and Contract Research Organizations while improving the quality of clinical research, enhancing safety, maintaining full patient confidentiality, and significantly reducing the study-related costs. 

Having experience with compliance in pharmaceutical industry in particular and the healthcare industry overall, Langate has come up with a technical solution based on the de-identified Unique Identification Codes, that detects and prevents the attempts to enroll in multiple clinical trials at the same time and ensures the high level of data security.  

Using the power of modern technologies, Langate has helped Verified Clinical Trials create a system that provides a high level of clinical research patient safety and data integrity. While maintaining confidentiality and being fully HIPAA & GDPR compliant, such a solution was validated by third-party entities and is currently successfully used worldwide.     

Do you need to develop a compliant healthcare solution?
Contact us!


Healthcare has a variety of regulations that guarantee high-quality care for the patients and protection from governmental penalties for healthcare providers. SaaS’s main concern in healthcare is data protection and privacy. Countries such as the USA, Australia, Canada, and EU-countries have different IT regulatory compliance standards in healthcare that define sensitive information differently, give more or less freedom to data providers, and demand different penalties.   

It is essential for healthcare providers to pay attention to the regulations that are applicable in their countries and invest in SaaS that will follow the regulations and prevent healthcare units from fines and additional costs. From this article, you have already learned about notorious violation cases, so don’t tempt fate. Investing in good SaaS is cheaper than fixing the consequences of a bad one.     

If you want to ensure the compliance of your current healthcare SAAS solution or develop a custom one, feel free to contact the Langate team, so we would help you create a system that adheres to all regulations.   

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