Software development for medical devices

Cybersecurity in medical device software development

Increasing demand for medical device software development services has led to more potential cybersecurity risks. The more complex and interconnected a medical device network is, the more difficult it is to maintain a high level of data protection and the more experienced a software development partner you need. Even a single device that isn’t securely connected could pose a threat to the whole hospital network. When looking for a software development company, it’s crucial to pay attention to the security measures they implement during the development process and the steps they take to comply with healthcare laws and regulations.

Your potential software development partner should first and foremost prioritize security during the whole development lifecycle, starting from writing code and finishing with releasing that code to the production environment.

To establish a secure software development lifecycle (S-SDLC) early on, we:

• integrate a range of security controls including static application security testing (SAST), infrastructure as code (IaC) scanning, dynamic application security testing (DAST), and cloud security audits

• timely detect and fix software vulnerabilities

• protect the CI/CD pipeline from pushing vulnerabilities into production

• enable visibility of application security via insightful dashboards

• ensure a flexible security ecosystem that can easily scale without lots of workarounds

It’s also important that all stakeholders involved in medical device development (developers, quality assurance engineers, and even project managers) have an equal understanding of the cybersecurity process and are aligned to develop a foolproof digital medical device solution. That’s definitely the case with the Yalantis software development team.

Ensuring secure software development for medical devices

Working with sensitive patient data obtained from medical devices requires implementing robust measures to protect this data under any circumstances. Such measures include encrypting data and implementing strong and reliable access controls. As a healthcare service provider, you can also take your own security measures, such as implementing password policies and training staff on cyber threats and how to prevent them.

Here’s an example of how we ensured a high level of security during the medical device software development process for one of our clients:

• Established SSL-based connection protocols for securely exchanging data between system users and the server

• Isolated access to the database to enable connections only via the internal network

• Implemented blocking of suspicious users

• Integrated a strict password policy

• Ensured timely detection and prevention of any suspicious activity

• Added an encrypted communication layer

These security measures helped us establish a reliable security ecosystem for an enterprise healthcare solution and ensure that the product is safe to use, allowing the client to continue spreading their vision of a healthy lifestyle.

Let’s take a look at another healthcare project and the specific security precautions we implemented when developing a medical imaging system:

• Developed a secure private network to enable secure data exchange between hospital facilities and the cloud

• Ensured that the radiology department’s local server was the only storage location for original medical images

• Made sure that other software solutions including an electronic health record (EHR) system and central server contained only links to the original medical images

Such measures helped us build an intricate system for protecting medical images while implementing software interoperability and enabling a smooth exchange of medical images across the whole hospital network. We also developed separate secure hospital infrastructure and cloud infrastructure to split the responsibilities and not overload the local hospital server. The result was that hospital infrastructure was mainly responsible for periphery medical equipment and storing medical images, while cloud infrastructure mainly performed the supportive role of an orchestrational service, a conditional access service, and a media conversion service. In such a manner, we created a distributed high-performance medical imaging system that saves radiologists’ time on diagnostics and eliminates the need for hard-copy medical images.

These projects prove that even though most healthcare security mechanisms for software development are rather straightforward, what matters most is how you combine them and implement them into each individual healthcare network. The latter requires experienced guidance and a professional healthcare software development team. It’s also critical to remember that cybersecurity is an ongoing process that doesn’t end with the software release. You’ll still have to continue performing regular security checks and audits to avoid the risk of patient data breaches. Plus, cyber threats are changing and getting more elaborate with time, requiring security specialists to stay constantly updated on the latest trends and keep their healthcare systems resistant to the latest cyber attacks.