Quality Assurance Testing
in Healthcare Software:
Why It Matter

With healthcare going digital and AI technologies advancing fast, software systems are now the mainstay of the digital health ecosystem. These healthcare solutions not only help deliver patient care but also streamline workflows for healthcare workers, insurance companies, and administrative staff.

But this software ecosystem does not run like a well-oiled machine on its own. For that to happen, each of the software systems must be safe and reliable. The best way to verify this is performing Quality Assurance (QA) testing. Put simply, QA ensures healthcare software complies with regulatory standards and is secure, functional, and effective.

Key Takeaways:

• QA helps validate the safety and reliability of software.
• Healthcare software requires compliance with regulations like HIPAA.
• The FDA reviews Software as a Medical Device (SaMD) via the De Novo pathway.

1. Understanding Quality Assurance for Healthcare Software

QA is a systematic process that healthcare organizations use to prevent software failures. Getting QA approval means the software systems they use or are about to roll out meet predefined standards of safety, functionality, and reliability. The goal is to validate that the software does its intended tasks without errors and poses no risk of harm to patients ⁽¹⁾.

Healthcare software includes a variety of systems such as telehealth solutions, hospital management systems, pharmacy management solutions, patient engagement tools, and many more. All these systems are integral parts of the broader digital healthcare ecosystem. Think of them as components of a sophisticated machine where each has a role to play for it to work well. Moreover, since all of them handle sensitive patient data, any malfunction as minor as a bug or glitch might compromise the entire infrastructure. Put simply, there is no alternative but to run them through QA testing to avoid a possible system failure ⁽¹⁾,⁽²⁾.

2. Types of Quality Assurance in the Healthcare Industry

Quality Assurance: Healthcare Software Testing

This QA testing assesses software commonly used to streamline workflows in medical facilities or individual healthcare. These include mobile health (mHealth) applications, patient portals, data analytics software, electronic medical records (EMR) system, and other healthcare software. For healthcare organizations, relevant international standards include IEC 62304 (software lifecycle processes) and ISO 13485 (quality management systems for medical devices). Meeting these standards as part of QA ensures their software systems are safe and reliable ⁽³⁾.

Quality Assurance: Medical Device Software

Any software products that control medical devices fall under this QA testing. These range from complex diagnostic equipment to smaller devices like insulin pumps. Obtaining QA approval for these devices means that the hardware and software are in sync and meet regulatory standards, such as FDA’s 21 CFR and Section 201(h) of the FD&C Act. Additionally, compliance with standards like IEC 60601 (safety of medical electrical equipment), ISO 14971 (risk management), and ISO 13485 is mandatory to guarantee the safety, effectiveness, and proper functioning of medical devices ⁽⁴⁾,⁽⁵⁾.

Quality Assurance: Medical Laboratory Equipment and Other Devices

Excluding the software, this type of QA focuses solely on medical equipment. For QA approval, healthcare organizations must comply with IEC 60601 standards. Compliance with IEC 60601 means that the tested medical device is safe and reliable for use in healthcare environments and meets electromagnetic compatibility (EMC) standards (does not interfere with other electronic devices) ⁽⁶⁾.

De Novo Pathway for Novel Devices

The De Novo pathway was introduced under the FD&C Act in 1997. The aim was to make market entry easier for novel medical devices that are of low to moderate risk. This is exactly why this FDA review process does not include predicate devices. This premarket pathway has been particularly helpful for reviewing Software as a Medical Device (SaMD) and new in vitro diagnostics (IVDs), including genomic tests. The FDA’s Pre-Cert Program, which ran from 2019 to 2022, further explored this pathway to evaluate and regulate SaMD ⁽⁵⁾,⁽⁷⁾.

3. Key Quality Assurance Tests for Healthcare Software

Functional Testing

This is one of the most basic tests to perform. It checks whether the software meets the required specifications and does its intended tasks without errors.

Performance Testing

Another important test that assesses if the software could perform as expected under different workload and how much stress it could endure.

Usability Testing

Healthcare software should be intuitive enough for all users. Usability testing determines how easy the software is to use.

Security Testing

Healthcare organizations must uphold the privacy and confidentiality of patient data. This is why security testing is essential for software. Getting a QA pass means it is not vulnerable to threats like unauthorized access, data breaches, and malware.

Compliance Testing

This would stay at the top of the ladder of QA tests. It validates that the software complies with predefined safety and performance criteria set by regulatory bodies such as FDA regulations for SaMD or HIPAA data security requirements.

4. Validate Your Healthcare Software with IT Medical’s QA & Testing Services

Struggling with regulatory compliance for your healthcare software? IT Medical can help. We specialize in quality assurance testing to ensure your systems are reliable, secure, and fully compliant. Our team has extensive experience in complying with international standards like HIPAA, IEC 62304, DICOM, ISO 13485, HL7, and FDA requirements.

We know how critical QA testing is for protecting patient data and optimizing performance. Our certifications include CISSP, PCI, FIPS 140-2, ISO, GDPR, and HIPAA, with full alignment to HL7 International standards.

Partner with IT Medical today. Our QA experts will guide you through compliance. Contact us now to learn more.

References

1. Ravizza, A., Sternini, F., Giannini, A., & Molinari, F. (2020). Methods for preclinical validation of software as a medical device. HEALTHINF 2020-13th International Conference on Health Informatics, Proceedings; Part of 13th International Joint Conference on Biomedical Engineering Systems and Technologies, BIOSTEC 2020 (pp. 648-655). SciTePress.

2. Cawthra, J., Cawthra, J., Grayson, N., Pulivarti, R., Hodges, B., Kuruvilla, J., … & Zheng, K. (2022). Securing telehealth remote patient monitoring ecosystem. US Department of Commerce, National Institute of Standards and Technology.

3. Karthika, B., & Vijayakumar, A. R. (2022). ISO 13485: Medical devices–quality management systems, requirements for regulatory purposes. In Medical Device Guidelines and Regulations Handbook (pp. 19-29). Cham: Springer International Publishing.

4. Zinchenko, V., Chetverikov, S., Akhmad, E., Arzamasov, K., Vladzymyrskyy, A., Andreychenko, A., & Morozov, S. (2022). Changes in software as a medical device based on artificial intelligence technologies. International Journal of Computer Assisted Radiology and Surgery, 17(10), 1969-1977.

5. International Medical Device Regulators Forum. (2017). Software as a medical device (SaMD): Clinical evaluation – Guidance for industry and Food and Drug Administration staff. (IMDRF/SaMD WG/N41FINAL:2017). U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health.

6. Siddeeq, M. A., Mythili, A., & Ahamed, S. J. (2021, June). The role of EMI/EMC for the medical devices according to IEC–60601-1 standards. In Journal of Physics: Conference Series (Vol. 1937, No. 1, p. 012052). IOP Publishing.

7. Sarata, A. K. (2023). FDA regulation of medical devices (R47374). Congressional Research Service.