Regulatory compliance plays a pivotal role in healthcare software development. It is one of the most challenging yet rewarding areas for healthcare. Healthcare software usually takes the responsibility of handling patient care, hospital administration, and medical data management. This is why developers have created functional solutions that comply with stringent regulations and policies.

This software sets high standards for patient care, efficiently protects their privacy, ensures safety, and upholds ethical industry standards. We will break down the key aspects of healthcare software regulatory compliance.

Why Is There a Need for Healthcare Software Compliance?

There are various reasons why healthcare compliance laws are important. Primarily, they’re all about keeping patients safe by ensuring that healthcare providers meet high standards of patient care.

For instance, HIPAA (Health Insurance Portability and Accountability Act) protects sensitive patient information and keeps it out of the wrong hands. This reduces the likelihood of data breaches and unauthorized access. 

Aside from patient privacy, compliance with software development in healthcare also promotes ethical behavior among health professionals in the industry. It helps them maintain public trust in the healthcare system. These laws ensure that healthcare organizations operate with integrity and avoid fraud or abuse, which is crucial for keeping the system fair and honest.

In addition to adhering to legal requirements, healthcare providers must also take financial considerations into account. Non-compliance can deny them access to government funding or insurance reimbursements.

These funds enable health institutions to function smoothly. Plus, these laws encourage regular audits and assessments. This can promote growth and improvements that are beneficial to patients and providers alike.

How to Comply With Healthcare Software Regulations

How, then, can you ensure compliance with your healthcare software? There’s no blueprint to this. However, we have outlined some best practices to align your systems with essential regulatory standards.

#1 Understand Applicable Regulations

First, you need to know which regulations are applicable to your software. You could even institute regulations based on the software’s services. Healthcare regulatory bodies like HIPAA set the standard for protecting patient information, while FDA regulations apply to medical devices that utilize software.

In other countries, developers must ensure that their software products are compliant with GDPR for data protection and the Medical Device Regulation (MDR) if their software qualifies as a medical device.

This means you need to thoroughly research the specific legal requirements of the country or region where you plan to deploy your software. If you are deploying globally, you will need to consider multiple regulatory bodies and ensure you meet their standards accordingly.

#2 Use Secure Software Development Practices

As much as compliance involves healthcare systems adhering to legal requirements and industry standards, it is also about creating software that’s secure by design. As a developer, you should consider adopting secure coding standards and methodologies. You can use the OWASP (Open Web Application Security Project) Top Ten, which can help minimize system vulnerabilities.

Another key part of software development in healthcare is continuous monitoring and vulnerability scanning. You need to be on the lookout to ensure that your systems are ready to combat cyber threats as they come. Every phase of the development cycle, from planning to post-release software updates, should prioritize security.

#3 Implement Data Privacy and Security Measures

Healthcare data is a target for hackers specifically because of its high value on the black market. Hence, healthcare software compliance is essential for robust data privacy and security practices. Compliant healthcare systems should include various vital components.

This includes data encryption, multi-factor authentication (MFA), and role-based access controls. Developers should also incorporate features such as data portability and the right to erasure. This gives users the liberty to have their details deleted when they need to. 

#4 Documentation is Key

You shouldn’t overlook documenting every aspect of the healthcare compliance software. The reports or documentation you have kept will serve as proof. You can provide it to healthcare regulators when they request evidence that you have adhered to the required standards throughout your system’s development processes. You can write reports on how you changed codes, your risk management procedures, and incident response plans.

For instance, let’s say you are working on a software project that will fall under the category of a medical device. In that scenario, FDA regulations may require you to provide comprehensive design history files (DHFs). Occasionally, they may require risk management files (RMFs).

In most cases, they request both. These documents provide details on the various aspects of your software development—how you started, the iterative tests, and the updates. This demonstrates that you developed the software in accordance with the established regulatory standards.

#5 Collaborate with Compliance Experts

Finally, developing regulatory-compliant software is a complex task. As a developer, you should consider collaborating with legal compliance experts. These professionals can provide expert guidance as you begin the development process.

They ensure robust compliance with all necessary guidelines and regulations for your software. This will reduce the risk of costly compliance violations.

Furthermore, certain types of healthcare software may require pre-market approval from regulators like the FDA. Hence, collaborating with compliance specialists early can significantly streamline this process.

How We Can Help

North South Tech turns healthcare compliance challenges into opportunities for innovation. We’ve built our reputation by creating healthcare software that meets stringent regulatory requirements while delivering exceptional patient care solutions.

Our development process integrates HIPAA, FDA, and global compliance standards directly into the architecture of every system we build. From secure patient portals to comprehensive hospital management platforms, we design each solution with privacy and security at its core.

Having guided healthcare providers through the complex landscape of regulatory compliance, we understand the critical balance between innovation and security. Our experience spans vulnerability testing, encryption implementation, and the development of fully documented, audit-ready systems that protect both healthcare providers and their patients.

Start your compliant healthcare software project by scheduling a consultation with us. One conversation could transform how your organization approaches healthcare technology.