The worldwide and U.S. healthcare systems are in a period of transition.
Innovation in medical care is resulting in better patient outcomes, but it is also creating new challenges for the software development teams charged with creating and deploying the applications that drive this innovation.
As the healthcare system increasingly moves towards a value-based model, the need for software that can help manage risk, improve patient outcomes, and drive operational efficiencies has never been greater.
At the same time, the regulatory environment in which healthcare software must operate is becoming more complex. On top of that, healthcare facilities are often targets of attacks by hackers. For example, in October 2022, the second largest US hospital chain was dealing with a “cybersecurity incident” that caused them to divert ambulances from some facilities, take their EMR systems offline, and had to take more actions to protect critical systems that in the end caused major disruptions.
In this blog post, we will explore some of the challenges facing software development teams in traditional healthcare, as well as in the BioTech, MedTech, and HealthTech fields, and the best practices that can help them meet these challenges.
1. Healthcare Software Development - Challenges and Strategies
The healthcare software development landscape is changing rapidly. New technologies, such as artificial intelligence and blockchain, are being applied to healthcare data to drive innovation in medical care.
At the same time, the regulatory environment in which healthcare software must operate is becoming more complex. The 21st Century Cures Act, for example, introduced new requirements for the development and deployment of healthcare applications.
The challenges facing healthcare software development teams are many and varied. But there are some common themes, such as:
- The need to balance regulatory compliance with the speed of innovation.
- The need for better collaboration between different stakeholders.
- The need for improved communication between development and clinical teams.
- The need for better security and privacy measures.
- Finally, the need to keep up with the changing technological landscape.
In order to meet these challenges, healthcare software developers need to establish best practices in the development and deployment of their applications. This includes the following strategies:
- Establish and adhere to a robust software development lifecycle – This involves everything from writing comprehensive requirements to defining and following a secure coding standard. By following an established process, teams can ensure that their software is secure, compliant and of a high quality.
- Adopting Agile and Test-Driven Development (TDD) approaches to ensure that applications meet the necessary quality and security standards, as well as regulatory compliance.
- Using Continuous Delivery (CD) tools and techniques to deploy software quickly and safely.
- Employing DevOps practices to foster collaboration between different teams, such as developers, IT, and clinicians.
- Improve communication between development and clinical teams – One of the biggest roadblocks facing healthcare software teams is a lack of communication between the development and clinical teams. By fostering better communication between these two groups, teams can ensure that the software is meeting the needs of the clinical team while staying compliant with the regulations.
- Integrating data from different sources to gain valuable insights into patient care.
- Establishing secure and effective data sharing protocols to enable the efficient exchange of health data across healthcare providers.
We will be covering these concepts and more in the following sections.
2. Establishing Best Practices for Quality Assurance
Healthcare software is often mission-critical, and it must meet the highest standards for quality and reliability. Establishing best practices for quality assurance is therefore essential for healthcare software development teams.
An important part of establishing best practices for quality assurance is understanding the regulatory requirements for healthcare software. The FDA, for example, has released guidance on the software development process, including the use of agile methodology. The FDA also has specific regulations for medical device software.
While understanding the regulatory requirements is an important step, healthcare software development teams should also have a quality assurance process in place that incorporates industry-standard practices.
This should include everything from regular code reviews and automated tests to user acceptance testing and performance testing. It is also important to have clear documentation and a version control system in place to ensure that the software is well-maintained and updated over time.
Additionally, developers should have a process in place for responding to bugs and other issues. This should include an issue tracking system and a support team to provide timely assistance to end users.
Adhering to best practices for quality assurance can help healthcare software development teams ensure that their applications meet the necessary standards for safety and efficacy.
3. Methodologies for Testing Healthcare Software
Testing is an essential part of the software development process. It is especially important for healthcare software, as these applications must meet stringent quality and reliability standards.
There are several different testing methodologies that can be used for healthcare software. These include unit testing, integration testing, regression testing, and usability testing:
- Unit testing focuses on the functionality of individual components of the software. It is used to check the functionality of individual units such as classes and methods in the code.
- Integration testing verifies the interactions between components of the software. The end-to-end functionalities of the software are verified, including the interactions between the user interface, database, and back-end services.
- Regression testing is used to check the previously implemented features of the software after changes have been made. It ensures that no existing features are affected by any modifications made to the software.
- Usability testing is used to assess the ease of use, accessibility, and overall user experience of the software. This testing helps ensure that the application’s user interface is intuitive and easy to use.
It is important to select the right mix of testing methodologies for the specific application. A healthcare software development team should work with a healthcare compliance consultant and at least some senior Quality Auditors and Automation Testers who are experienced in the healthcare industry to ensure that the application is properly tested.
4. Defining and Assessing Regulatory Processes for Healthcare Software
Another critical topic to keep in mind that oftentimes guides the whole quality assurance processes and strict rules is the topic of regulatory compliance.
The regulatory environment for healthcare software is complex and ever-changing. Healthcare organizations must have a clear understanding of the regulatory landscape in order to ensure that their applications meet the necessary standards.
There are a few different regulatory agencies that have a role in the development and deployment of healthcare applications. These include the FDA, the Centers for Medicare and Medicaid Services, and state licensing boards.
Each of these agencies has its own specific requirements that must be met. A healthcare organization should work with a regulatory compliance consultant to ensure that its applications meet the necessary standards.
5. Software Engineering: Meeting Regulatory Compliance Standards
Since the healthcare system continues to move towards a value-based model, the need for software that can help manage risk, improve patient outcomes, and drive operational efficiencies is greater than ever before. This has placed a new emphasis on the critical role of software engineering in healthcare, and the need for high-quality software.
Healthcare software must meet many different regulatory standards. In order to meet these standards, healthcare software development teams must have a strong understanding of the regulatory requirements.
To meet these standards successfully, working with a healthcare regulatory compliance consultant and a true and tested team of specialized developers is can help healthcare software development teams ensure that their applications meet the necessary standards.
One of the most critical compliance standards is HIPAA compliance. The risks from failing to adhere to the standard can be devastating to healthcare institutions and HealthTech companies.
6. HIPAA Compliance & Security Standards for Healthcare Software
HIPAA compliance is a complex and ever-changing landscape. Healthcare organizations must take a risk-based approach to ensure that their applications meet the necessary security and privacy standards.
There are several different security standards that must be met, such as the requirements for data encryption and the use of two-factor or multi-factor authentication. In addition, applications must be able to meet the strict requirements for auditing and logging.
HIPAA compliance can be a challenge for healthcare software development teams, but working with a healthcare compliance consultant and a software development team with domain experience can help ensure that applications meet the necessary standards.
7. Healthcare Software Architecture - Design Considerations
The architecture of a healthcare application is also a critical part of the software development process. The architecture must take into account the specific needs of the healthcare environment and the goals of the application.
There are several different design considerations that must be considered when designing the architecture of a healthcare application.
These include the following needs and considerations:
- Meet HIPAA compliance standards
- To support the scalability of the application
- High availability
- Secure authentication and authorization mechanisms
- Robust performance monitoring
- Effective data management and storage
- Appropriate data access controls
- Robust logging and auditing capabilities
- Automated testing and continuous integration
- Secure backup and disaster recovery capabilities
- Integration with other healthcare systems
- Medical device and system integration
- And much more
Diving deeper into a few examples, here is why each of these is so critical
Interoperability is a critical requirement for healthcare applications, as the application needs to be able to communicate and exchange data with other healthcare systems. The application must also meet the HIPAA compliance standards to ensure that patient data is properly secured and managed.
The application needs to be designed to be scalable, as the number of users and data will increase over time. The architecture must also support high availability, so the application is always available when needed. Amazon HealthLake could help here. It’s a “HIPAA-eligible service for healthcare and life sciences organizations to ingest, store, query, and analyze their health data at scale, adding it to a growing portfolio of health-specific services such as Amazon Comprehend Medical and Amazon Transcribe Medical."
Authentication & Authorization
Secure authentication and authorization mechanisms must also be implemented to ensure that only the right users have access to the data they need. Performance monitoring and data management must be implemented to ensure the application is performing optimally and data is properly managed.
Data Access Controls
Data access controls must be implemented to further protect data security. Logging and auditing capabilities should also be implemented to track user access and activities. Automated testing and continuous integration should also be implemented to ensure that the application is working as expected.
Backup & Disaster Recovery
Finally, secure backup and disaster recovery capabilities should be implemented in case of system failure or data loss. Medical device and system integration may also be required if the application needs to work with other medical devices and systems.
These design considerations should be carefully evaluated when designing the architecture of a healthcare application. It is important that the architecture is carefully planned and implemented in order to ensure that the application is secure, reliable, and performant.
As an example, ransomware attacks do happen more and more often. Are you sure your organization is prepared to deal with them?
8. Healthcare Software Deployment - Moving the Application to Production
Once a healthcare application has been developed, it must be deployed to a production environment. This can be a challenge, as healthcare environments are often complex and heterogeneous.
Deploying a healthcare application to a production environment requires a careful and well-planned process. The first step is to create a deployment plan. This plan must consider how the target environment and the application will interact between each other.
Before we even get to production, though, we must create a test environment that simulates the production environment as closely as possible. This is to make sure that the code that we are deploying will meet rigorous standards.
Finally, once deployed, one must monitor the software carefully. This will help ensure that it is functioning as expected and that any problems are identified and resolved quickly.
9. Patient Safety and Enhancing Patient Experience
Patient safety is a top priority for healthcare organizations. In order to ensure that patients receive the best possible care, it is essential to have systems in place that can identify and prevent errors.
Healthcare software can play a role in patient safety by providing alerts and reminders to clinicians. In addition, data analytics can be used to identify trends and potential problems.
Enhancing the patient experience is another important goal for healthcare organizations. Healthcare software can help by providing patients with access to their health data and by offering features that make it easy to schedule appointments and refill prescriptions. Automated messaging can also keep patients informed of their care status.
Furthermore, patient portals must provide a secure and convenient way for patients to communicate with their provider and access educational material. This can not only help them better understand their health conditions, but also increase patient engagement and satisfaction.
By leveraging patient feedback, healthcare systems can further tailor their services to meet the needs of their patients.
Finally, healthcare providers should also invest in training their staff on the use of healthcare software. Having knowledgeable and capable staff can ensure that healthcare software is being utilized in an optimal manner and provide a better experience for patients.
10. Balancing Quality Assurance and Speed of Development
Given the development complexity, stringent requirements, and need for airtight design and development, one of the challenges facing healthcare software development teams is the need to balance quality assurance with the speed of software development.
The pressure to release new features and functionality quickly can often result in corners being cut in the testing process. It is important for healthcare software development teams to establish a clear process for testing and quality assurance before any development starts and to continue improving the requirements to adhere to patient safety and wellbeing. This process should be followed for every new feature or function that is developed.
In addition, it is important to have a clear understanding of the risks associated with each new feature or function. This will help the team prioritize testing and ensure that the most critical features are tested thoroughly.
11. Measuring and Improving Performance of Healthcare Software
The performance of healthcare software is critical to the success of the healthcare organization. In order to ensure that applications are performing optimally, it is necessary to measure and track a number of different metrics.
Some of the metrics that should be tracked include uptime, response time, and user satisfaction. In addition, it is important to monitor the number of errors and incidents.
Tracking these metrics will help healthcare organizations identify problems and potential areas for improvement. In addition, it will help the organization set goals and target areas for improvement.
12. Automation in Healthcare Software Development
Automation is playing an increasingly important role in healthcare software development. Automated testing, for example, can help reduce the time and cost of testing.
In addition, automation can help reduce the risk of errors in the software development process. Automated tools can help enforce coding standards and prevent common errors.
Automation can also help improve the communication between development and operations teams. Automated deployments, for example, can help ensure that everyone is working with the same version of the code.
13. Moving Towards Continuous Improvement for Healthcare Software Development
Continuous improvement is a key goal for healthcare software development teams. There are a number of different ways to achieve continuous improvement.
One way is to establish a process for tracking and measuring performance metrics. This will help identify areas for improvement.
Another way to achieve continuous improvement is to automate the software development process. Automated testing, for example, can help reduce the time and cost of testing.
Finally, it is important to have a clear understanding of the risks associated with each new feature or function. This will help the team prioritize testing and ensure that the most critical features are tested thoroughly.
The bottom line
By following these best practices, healthcare software development teams can overcome the challenges they face and ensure that their applications meet the needs of the healthcare organization.
By understanding the regulatory environment, establishing best practices for quality assurance, and leveraging automation tools, teams can ensure that their applications are secure, compliant, and performant. With the right tools and processes in place, healthcare software development teams can help make healthcare more efficient and improve patient outcomes.