A Complete Guide to Regulatory Compliances When Developing a Healthcare SaaS Product

At a Glance

Law obligates manufacturers to follow regulatory compliances for healthcare SaaS product development. There is no exception for any service or product to escape this rule. Healthcare product development organizations have to abide by some of the strictest regulations with stringent monitoring/checks.

If you are an organization developing healthcare SaaS products and do not want to break any regulations unintentionally, this comprehensive guide is for you. You will learn about regulatory compliances for healthcare SaaS product development and why you must maintain these standards. This article will also touch bases with standards across the U.S, Canada, EU, and Australia.

The Need for Regulatory Compliances for Healthcare SaaS Products

Regulatory compliances for the development of healthcare SaaS products dictate legal practices to prevent harmful outcomes for anyone. Privacy security and data are two of the main elements when it comes to regulatory compliances for healthcare SaaS product development. 

Files stored in a cloud-based system are susceptible to cyber-attacks. Even encrypted data is vulnerable to interception on its route to a destination. That is why most people show concerns when sharing their data with healthcare products and services providers. Some even entirely refuse to share private information with digital healthcare providers.

Therefore governments are issuing strict laws and regulations for SaaS-based healthcare products, services, and industry.

Reason to Comply With the Regulations in SaaS-Based Healthcare Product Development?

Cloud security is constantly evolving, making it harder for healthcare SaaS-based software developers to keep up with the rapidly changing SaaS security regulatory compliances. However, if you are such an organization, it is your responsibility to keep yourself updated on all new regulatory requirements for developing SaaS solutions for healthcare.

The Healthcare industry is one of the heavily regulated sectors. Most organizations are always trying to fix any compliance issues before the government finds out and penalizes them for negligence. Therefore, you must follow regulatory compliances for healthcare SaaS products, or the government will fix it for you.

Here is how you can stay compliant with SaaS compliances in healthcare product development and benefit from doing so.

Developing Patient-Centric Solutions

Remember that improving patient’ care and safeguarding the privacy of data and information must be the primary goal of regulatory compliance for SaaS-based healthcare products. The governments have designed the rules and standards to ensure that every patient gets a right to access and control their private information to avoid fraud and data breaches.

A leak of such private information can harm a patient’s finances and cause irreversible damages. The Healthcare industry deals with highly sensitive information; hence the rules for data protection are stricter than other sectors.

Failing to follow these rules resulting in data breaches can be expensive for healthcare SaaS product development companies. According to a report, a data breach associated with healthcare can cost up to $7.13 million, which is almost twice as much as other industries.

Regulatory Compliances for SaaS Products in Different Countries

Countries around the world take healthcare patients’ privacy and cyber security very seriously. In this section, you will learn about the global regulatory compliances for healthcare products and projects.

·   HIPAA in the US

HIPAA stands for Health Insurance Portability and Accountability Act. This is a set of compliance and controls used widely across the United States under the supervision of the U.S Health Service Department (HHS).

HIPAA emphasizes securing ePHI and obliges the healthcare industry to ensure privacy when using digital and electronic means to handle data and information, including SaaS-based solutions. Although information regarding compliances is very precise, SaaS-based healthcare product developers sometimes end up breaking these rules unintentionally.

Here are HIPAA-compliant software requirements to help you develop a SaaS-based healthcare product.

·   Access control

·   Automatic log-off

·   Authorization monitoring

·   Data backup feature

·   Data encryption and decryption for information and data security

·   Emergency mode

·   Remediation plan

·   User authorization

Suppose you are a healthcare software developer that meets HIPAA’s SaaS healthcare regulatory compliances. In that case, you can create a product to handle records, radiology, pharmacy, and laboratory systems in a cloud-based environment while maintaining privacy.

Organizations found guilty of non-compliance for the aforementioned regulations may face penalties depending on the level of negligence. A penalty may cost you $100 to $50,000 and may reach up to $1.5 million annually for each violation.

·   HITECH in the US

HITECH stands for Health Information Technology for Economic and Clinical Health Act. This is a set of rules and regulations complementing HIPAA, focusing only on electronic, IT, and SaaS-based health record handling.

HITECH clearly outlines civil and criminal compliance penalties based on factors such as resolving the timeline and willful neglect by the developing organization. HITECH gives patients the right to request a report about third parties the healthcare organization shares the information with and under what authority. A violation of HITECH violation may cost up to $1.5 million.

·   PIPEDA in Canada

PIPEDA stands for Personal Information Protection and Electronic Document Act. This compliance regulation for healthcare SaaS product development is applicable in Canada and is somewhat similar to HIPAA. However, PIPEDA covers more aspects than HIPAA.

For instance, PIPEDA requires a cloud-based healthcare product development industry to protect patients’ data in medical apps as well. Failing to comply with these regulations will result in up to $100,000 for each violation.

·   GDPR in the European Union

GDPR or General Data Protection Regulation defines the regulatory compliances for healthcare SaaS product development within the European region. It broadens and envelopes the definition of handling sensitive data, adding biometric, IP addresses, genetic data, and information on ethnic and racial origin as well as religion.

The patients can request healthcare SaaS-based organizations to delete any data associated with their medical records. Furthermore, the users can also withdraw their consent to collect and share data anytime. A company developing a SaaS-based healthcare product found in violation of GDPR may face fines of up to €10 million.

·   OAIC in Australia

OAIC is an acronym for Office of the Australian Information Commissioner. The OAIC defines the regulatory compliances for healthcare SaaS products and establishes the rules for companies to collect, store, secure, and disclose patients’ information.

The main highlights of OAIC are:

·   All patients should have full authority and control over their sensitive information and data

·   All healthcare facilities and SaaS-based service providers must enforce complete network security. The organizations must immediately report any incidents of data breaches to the relevant authority.

Failing to comply with OAIS regulations can result in up to 2 years of imprisonment or fines of up to 2.1 million Australian dollars, or 600 penalty units.

How to Avoid Penalties?

Surely, you would not want to fall on the wrong side of the law when it comes to regulatory compliances when developing healthcare SaaS products. Therefore, you must only check reliable sources HIPAA, HITECH, PIPEDA, GDPR, and OAIC to get up-to-date information.

A single instance of negligence in developing an unreliable SaaS solution for healthcare may cost you millions. To add to an injury, the press and media can bring your company a bad reputation with irreversible damage.

Therefore, you must do your best to avoid facing penalties. It is better to implement SaaS protocols adequately than paying a large sum of fines costing you millions of dollars.

In order to avoid penalties, you must be aware of all regulatory rules and compliance risks associated with the type of SaaS-based product you are making. Compliance risks expose you to financial and legal fines in case the government you are guilty.

Regulatory risks deal with changes in regulations and your company failing to keep up with the updated version of the rules. This will have an adverse effect on your company’s operation and reputation. As long as you pay attention to both risk factors and rectify the possible causes, you can easily avoid penalties in the long run.

You must remember that each country has its own IT regulatory standard for SaaS-based healthcare products development. So, check the following details within your country.

·   What is the definition of data-sensitive data in your country?

·   What are data privacy and protection laws in your country?

·   How much freedom of data control do you require to provide data providers/patients?

·   What are the penalties?

Knowing the answer to the question mentioned above will certainly help you streamline your SaaS product development aligned with the most updated laws.


Now that it’s obvious how important it is to follow regulatory compliances when developing a healthcare SaaS product, you must stay updated with compliances in your region. Remember, it is all about protecting the sanctity of patients’ data and ensuring its privacy and security.

This will ensure that your SaaS solution continues to provide high-quality healthcare services to the patients. Additionally, it will also help you stay in the good books of the government and other regulatory authorities.

If you are a healthcare SaaS product Development Company, following the information and resources mentioned in this guide will help you stay on top of ever-evolving regulatory compliances. If you are unsure whether you are compliant, it is always a good idea to seek legal assistance and hire an expert in SaaS compliance and regulatory laws.

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