Anmol: Hello and welcome to another episode of the Unthinkable Tech Podcast. Today, we discuss a topic that is crucial when you’re dealing with patient data. I’m talking about healthcare software compliances. We are in an era where data breaches and privacy concerns dominate the headlines. Ensuring that healthcare software meets stringent regulatory standards is becoming all the more important. But what does it actually take to navigate this complex landscape successfully? How do we balance innovation and compliance at the same time?

To help us unravel this, we have a very special guest with us today. Apoorva Chand, Health Tech Consultant at Unthinkable Solutions. Apoorva brings a wealth of knowledge and hands-on experience in helping health tech organizations meet compliance standards. Welcome, Apoorva, excited to have you on the show.

Apoorva: Thank you, Anmol, for your kind words. It’s a pleasure to be here.

Balancing innovation and compliance in healthcare software

Anmol: The pleasure is all ours, Apoorva. So to begin with, I would like to mention that we all are aware that technological innovations are happening at a very rapid pace in the healthcare industry specifically, but it is also very heavily regulated to ensure safety and data security, which is, of course, the priority. It seems that it creates a challenge for health tech companies as, on the one hand, they are constantly striving to develop cutting-edge solutions, and on the other hand, they must adhere to all rigorous standards and regulations. So, my question to you is, how does a company strike that perfect balance between innovation and compliance?

Apoorva: See Anmol, balancing innovation and compliance in the health tech industry is no small feat. But it’s crucial for success. We have been dealing with numerous clients to navigate this delicate balance and have come across some key strategies that have worked wonders for our clients.

To start with, I will tell you about one of my project experiences. The client had a vision to have an application that covers the complete journey of the patient, from scheduling the appointment to their claim settlement, along with the patient portal app. The app would store a lot of patient health information. Considering the volume of patient medical records and personal data, it required careful planning and execution along with the best development practices to ensure that we were building a compliant application.

So, for this, we came up with several plans to make sure the innovative area the client had should meet with compliance and have success in the market eventually. We started by understanding the regulations required, like HIPAA in the USA and GDPR in Europe. Another effective strategy is to build a cross-functional team. We always recommend having both technical experts and compliance officers work together. This way, innovative ideas are evaluated with regulatory requirements in mind.

We also had regular training and updates, which are crucial because regulations can change, and staying updated is essential. We conduct quarterly training sessions for our developers and test engineers to ensure the team is always informed about the latest compliance requirements. This makes it easier to adapt and innovate without falling foul of regulations.

Development and testing are another key approach. By adopting the iterative approach, where solutions are continuously tested against compliance standards, issues can be caught and fixed early. This way, we made it a habit for the test engineers to not just test the application as per the requirement but also as per the compliance requirement. This makes our product more helpful for the compliance part. It’s important to remember that innovation and compliance can coexist. When balanced effectively, they can drive the business forward. By these measures, we can have a balance between innovation and compliance in the health tech industry. This has worked for me, so I would suggest the same thing to everybody.

Overview of key healthcare compliance standards globally

Anmol: Okay, that was an interesting example and some crucial strategies, Apoorva. Moving on, you mentioned regulations like HIPAA in the US and GDPR in Europe. I think these are just a couple of the many standards out there. So, for our listeners who might be navigating this space, could you give us an overview of the key regulations and compliances that healthcare software companies need to be aware of, and how they vary geographically?

Apoorva: Yes, I’d be happy to explain the regulations and standards of each of the compliances we have. To start with, I will start with the USA one. In the United States, we have a very big HIPAA compliance that everyone talks about. If the app is in the health tech industry, it should be HIPAA compliant. HIPAA stands for Health Insurance Portability and Accountability Act. HIPAA is all about protecting patient information. If your software handles patient data, you need to make sure it’s secure and private; no one can have access to that particular patient information, as this is very critical. This means encrypting data, controlling who has access to it, and regularly checking for any security issues.

I myself have worked on a USA-based EHR project where we built a specific functionality just to store patient information. We developed a user role specification so that every user had specific roles, and only the allowed users could access the patient information. This user role can be one of the best practices to protect HIPAA in the USA.

Moving forward to Europe, we have GDPR. GDPR is broader than HIPAA because it’s about protecting all personal data, not just health information. It requires companies to get explicit consent from the user, like patients, before collecting their data, and it gives users the right to access, correct, or delete their data. Basically, any update in patient information needs the consent of the patient for the changes to be made. So, if you’re operating in Europe, you need to be very transparent about what data you’re collecting and why.

In addition to these, there are other important standards to consider as well. For example, in Singapore, we have PDPA, which regulates the collection, use, and disclosure of personal data by organizations. It emphasizes obtaining consent and ensuring data accuracy. Then, we have ISO 13485, an international standard for medical devices. If your application deals with any medical devices, you should be compliant with ISO 13485 to ensure it is safe and effective because these devices will eventually be used by patients.

In the United Kingdom, we have the NHS Data Security and Protection Toolkit. This provides a framework for ensuring data security and protection in the UK’s National Health Services. It covers areas such as data protection, information governance, and incident management.

These regulations can seem overwhelming, but with proper planning, they can be achieved.

Anmol: Yeah, it sounds like there’s a lot to keep track of. Different regions have their own set of regulations, but I think, in the end, all of them aim to protect patient data and ensure privacy. So now that we are aware of how critical compliance is, it makes me wonder about the best time to address compliance. Apoorva, when should companies start checking for compliances? Should it be done before the product is ready, or is it better to integrate compliance checks earlier in the development cycle? What are your thoughts?

When should healthcare companies start checking for compliance?

Apoorva: I believe that compliance checks should start early in the development cycle and continue throughout. Starting early ensures that compliance is built into the product from the ground up, reducing the risk of significant issues later on. Waiting until the product is ready can lead to costly rework and delays. Integrating compliance at each stage of the development process, from planning to maintenance, is the best approach according to me.

Anmol: Yeah, that actually makes sense, Apoorva. Starting early can definitely help in avoiding last-minute rushes and potential pitfalls. But building on that, could you walk us through the steps that health tech companies can take at each stage of the development lifecycle to ensure that they are fully compliant?

Step-by-step compliance in the software development lifecycle

Apoorva: Sure. As we discussed earlier, at every stage, we have to continue compliance checks. These are some steps that can be followed at each stage by health tech companies.

The first step in every product development is requirement gathering. At this stage, we need to identify all regulatory requirements that the software must comply with. This involves understanding the relevant laws and standards such as HIPAA, GDPR, and ONC certification requirements, and engaging with legal and compliance experts early to ensure all the necessary regulations are considered. There can be situations where we assume a particular compliance says something else, but the compliance expert says, no, this is like that. So, all these things should be handled at the stage of requirement gathering.

Then comes the product designing phase. In this phase, we need to ensure the software architecture supports compliance requirements. This can include designing systems for secure data storage, implementing encryption, and ensuring data integrity. The solution architect should keep these points in mind while designing the system. They can also incorporate role-based access control to restrict access to sensitive information based on user roles. Additionally, they can have some audit trails to track what has been edited by whom and when keeping a logging mechanism to track access and modification of patient data.

Next is the development phase. When I mentioned we should continue compliance checks, I was talking about the development phase. Generally, some issues are left in this phase because developers are focused on developing the system and might miss compliance standards. We should follow coding standards and practices to ensure compliance, using secure coding techniques to avoid any hiccups later on, such as SQL injections and cross-site scripting. At the code level, we should also implement audit trails to track errors or missing data.

Conduct regular code reviews and security assessments to identify and address potential compliance issues. Then comes the final stage of development, which is testing. As I mentioned previously, how testing is incorporated with compliance can boost the system. Include compliance testing in the strategy, validate that all regulatory requirements are met, and perform comprehensive security testing. Use automated testing tools to check for compliance with standards and regulations. These automation tools, like JMeter, can help a lot by allowing bulk testing to ensure the system can handle multiple users simultaneously.

By integrating compliance checks at each stage of the development cycle, health tech companies can create applications that not only meet regulatory requirements but also build trust with users and stakeholders. This proactive approach helps avoid last-minute rushes and potential pitfalls, ensuring a smoother and more secure development process.

Anmol: Right, right. That was a really thorough breakdown, Apoorva. And I think it’s clear that compliance isn’t a one-time effort but something that needs to be woven into every stage of the development lifecycle. Considering all these stages and the need for continuous checks, are there any tools or frameworks that you consider to work best when managing compliances? You just mentioned some automated testing tools, right? There must be many others. Can you walk us through that?

Top tools & frameworks to manage healthcare software compliance

Apoorva: Yes, there are several tools and frameworks that can assist in managing compliance effectively. Talking about the automated testing tools, we have Selenium, JUnit, and JMeter. These tools can be included in our compliance testing. These tools help ensure regulatory requirements are met. In Selenium, for instance, you just need to make the code compliant, and then the tool will test the code automatically and generate a report for you.

Then come the static code analysis tools. This is for the development phase I mentioned earlier. We can use SonarQube, which is one of the best examples of a static code analysis tool. SonarQube helps ensure code adherence to secure coding practices. The tech lead or solution architect can configure SonarQube to check for issues like code repetition and unnecessary table creation. In my current project, developers use SonarQube to ensure code quality meets the standards. We are currently working on an EMR and EHR project using SonarQube.

Then come the compliance management platforms. Solutions like ComplyTrack and RSA Archer help manage and track compliance requirements and audits. These platforms offer centralized management of compliance activities, documentation, and reporting.

For security frameworks, we can implement frameworks like NIST and HITRUST. HITRUST is widely used in the USA. These frameworks ensure that software meets security compliance standards, providing guidelines and best practices for securing data and managing risk.

Then comes the CI/CD pipeline. This is again the development phase. Integrating compliance into continuous integration and continuous delivery (CI/CD) pipelines ensures compliance is verified with every build and deployment. This approach automates compliance validation and reduces the risk of human error.

Anmol: Now that we have discussed why and how we can meet regulatory standards, I want to know what happens if somebody fails to meet these regulations. How can it affect companies in both the short term and long term?

Consequences of non-compliance: Financial, Legal & Reputational

Apoorva: Non-compliance can have serious repercussions. Financial penalties can be substantial. For example, in 2020, a large healthcare provider was fined $6.85 million for HIPAA violations.

Anmol: Yeah, that is actually a very huge number.

Apoorva: Right, and that’s just for HIPAA. This shows how important these compliances are. Talking about fines, I remember a client whose product was not ONC-certified. He faced hefty fines every month. To give you an overview, ONC certification ensures that the product meets standards for security and functionality, which are critical for maintaining compliance. Without ONC certification, he was unable to use his product in multiple clinics across the USA.

Non-compliance can have short and long-term impacts on the business. In the short term, beyond fines, non-compliance can lead to legal liabilities, including lawsuits from patients whose data may have been compromised. These lawsuits can be costly and time-consuming, diverting resources away from the company’s primary focus and damaging its financial stability.

Apart from financial and legal issues, there’s reputational damage. In healthcare, trust is everything. If a company fails to comply with regulations and experiences a data breach or compliance issue, it can suffer significant reputational damage. Patients and partners may lose trust in the organization, leading to a loss of business and partnerships. Rebuilding this trust can be incredibly challenging and time-consuming.

In the long term, non-compliance can hinder a company’s growth and market expansion. For example, a company that fails to meet GDPR standards may find it challenging to operate in the European market. Similarly, lacking ONC certification can limit a company’s ability to work with certain healthcare providers and organizations in the USA.

To summarize, the impacts of non-compliance are extensive and can affect health tech companies financially, legally, operationally, and reputationally. Ensuring compliance from the outset is not just about avoiding penalties; it’s about building a sustainable, trustworthy business. By prioritizing compliance, companies can protect patient data, maintain trust, and ensure long-term success.

Anmol: That was quite interesting to know. Now, as we come to the end of the episode, I am curious to know about how emerging technologies are influencing the healthcare landscape. What future trends do you foresee in healthcare compliance, and how should leaders prepare for them?

Future trends

Apoorva: Talking about future trends and how leaders should prepare for them, the upcoming areas are AI, blockchain, and IoT. One thing I believe is that health tech experts should be investing in advanced technologies. These advanced technologies will enhance their compliance capabilities, which include adopting compliance management platforms that integrate these technologies.

To further explain, AI helps automate compliance monitoring and detect potential violations in real-time, reducing the burden on humans. On the other hand, blockchain offers a secure and transparent way to handle patient data, ensuring data integrity and traceability, which is crucial for compliance.

Health tech experts should also invest in collaboration with tech experts. There are multiple consultants specialized in healthcare compliance and emerging technologies. They can provide valuable insights and help effectively implement new technologies for compliance.

To summarize, emerging technologies are reshaping the landscape of healthcare compliance, offering new tools and methods to ensure regulatory adherence and data security. By embracing these technologies and preparing for future trends, healthcare organizations can not only meet compliance requirements but also gain a competitive edge in the market, drive innovation, and improve patient care.

Anmol: That is really insightful, Apoorva. Thank you so much. These technologies do offer incredible potential to streamline compliance efforts and improve patient care overall. Well, that brings us to the end of the episode. Apoorva, thank you so much for sharing your expertise and knowledge with us. You have provided a wealth of information that is invaluable for anyone navigating the complex landscape of healthcare compliance.

Apoorva: Thank you, Anmol. It was a lovely experience talking with you.

Anmol: And to our listeners, thank you for tuning in for this episode of the Unthinkable Tech Podcast. If you found this discussion helpful, don’t forget to subscribe and leave us a review. Until next time, stay compliant and keep innovating!