Podcast Summary
Healthcare software regulations: Understanding healthcare regulations and mapping them to specific technical implementations is crucial for developers in regulated industries like healthcare to pass audits.
Creating software in a regulated industry like healthcare comes with unique challenges for developers. MedPlum, an open source electronic health record development platform, is an example of this. The regulations and programs governing healthcare applications require specific technical implementations, such as data privacy regulations like HIPAA, and specific interfaces mandated by the government. Developers cannot create their own data models or identity management systems; instead, they must inherit them from the regulations. Interpreting these regulations correctly and mapping them to the regulated environment is crucial to pass audits. The Smart on FHIR specification, which is similar to OAuth 2 but more specific to healthcare, adds on extra scopes and a data model. While it simplifies some aspects, it also adds complexity. Overall, the process of creating software in a regulated industry requires a deep understanding of both the technical and regulatory aspects.
Regulatory testing in healthcare: Regulatory testing is crucial in healthcare, and TDD, source control, and a strong understanding of regulations are essential to ensure applications pass regulatory scenarios and maintain compliance.
In the healthcare industry, adhering to regulations while maintaining a fast pace of development is crucial. The Center for Medicare and Medicaid Services (CMS) provides a test harness named Inferno to ensure applications pass regulatory scenarios. Test-driven development (TDD) is essential in this context, as it allows for rigorous testing and change management. Regulations are tagged with tests and documentation in source control, making it easier to track when changes were made and passed. However, the large surface area of functionality required in regulated industries can make it challenging to ensure all less frequently used features are tested. The ONC certification process involves demonstrating application functionality in a lab setting, with annual audits. Open source software can add complications due to regulatory misunderstandings, but it also offers benefits such as community collaboration and additional eyes on the code. Overall, TDD, source control, and a strong understanding of regulations are key to navigating the complexities of developing in a regulated industry.
Regulated industry compliance: In regulated industries, focusing on code compliance through tools and infrastructure as code, maintaining a robust CI/CD process, and understanding data flow, specialized skills, and potential non-compliant patterns are crucial for avoiding fines and legal consequences.
In a regulated industry, ensuring compliance involves dealing with both code and infrastructure. For software providers, focusing on code compliance through tools like code scanners and infrastructure as code is crucial. Maintaining a robust CI/CD process with continuous testing and updates is essential for releasing changes confidently. From an engineering perspective, working in a regulated industry requires understanding data flow, specialized skills in data platforms and pipelines, and a keen awareness of potential non-compliant patterns like unauthenticated access, cookies, and impersonation. The healthcare industry, in particular, has shown that ignoring these issues can lead to fines and legal consequences.
Regulated industries cross-functional skills: Engineers with cross-functional skills, including regulatory navigation, effective communication, and technical-non technical bridge building, are highly valued in regulated industries. Logging, observability, flexibility, and good change history are essential for maintaining regulatory requirements.
In regulated industries, cross-functional skills are highly valued for building and certifying apps. Engineers with the ability to navigate regulations, communicate effectively, and bridge the gap between technical and non-technical aspects are extremely valuable. Compliance is a critical consideration at every level, and logging and observability are essential for maintaining regulatory requirements. Flexibility and a good change history are necessary to adapt to changing regulations. Tools like Vanta, Secure Frame, CDK, and DocuSaurus have made it easier for organizations in regulated industries to manage compliance and maintain documentation effectively. Overall, regulations provide a framework for creating ethical and secure software, and the increasing literacy and tooling in this area is a positive development.
Healthcare data challenges: The digitization of healthcare presents challenges related to data quality, governance, and security, but AI and other tools can help address these issues and improve patient care. Collaboration between stakeholders is crucial to ensuring secure and effective use of healthcare data.
The digitization of healthcare is a promising development, but it also presents challenges related to data quality, governance, and security. The increasing use of technology in healthcare, such as GitHub actions and CICD, can save time and improve efficiency. However, the vast amount of unstructured medical data and the need for robust identity matching pose challenges. AI and other tools can help address these challenges by handling poor data quality and unstructured data. Additionally, there is a missed opportunity to utilize and reuse medical data to improve patient care. The future of healthcare data management lies in the development of nuanced tools that allow patients to control access to their data. However, governance and security remain unsolved issues, and the potential risks of data breaches and unauthorized access are significant. Community-wide initiatives and collaboration between stakeholders, including regulators, healthcare providers, and technology companies, will be crucial in addressing these challenges and ensuring the secure and effective use of healthcare data.
Insurance industry innovation: The insurance industry, like finance and healthcare, can benefit from innovation and knowledge sharing to overcome complexities and challenges
The insurance industry, like healthcare and finance before it, is ripe for innovation and transformation. The complexity and difficulty of making changes to insurance plans and policies mirrors the challenges faced in finance during its fintech revolution. Any industry where getting things done and achieving desired outcomes is a struggle is ripe for disruption. A specific example of this was addressed during the show when the difference between Bitteray and Bull was clarified. KVAM, a Stack Overflow user, provided an answer to a question that had been saved from the dustbin of history. This serves as a reminder that the insurance industry, like other industries, can benefit from the sharing of knowledge and expertise. Overall, the discussion underscores the importance of innovation and the power of knowledge sharing in addressing the challenges and complexities of various industries.