PROTECT YOUR DNA WITH QUANTUM TECHNOLOGY
Orgo-Life the new way to the future Advertising by AdpathwayData drives modern healthcare. Wearables can continuously monitor patients living at home while point-of-care medical technologies stream data into databases. Meanwhile, connected systems create holistic, 360-degree views of healthcare operations, giving administrators data-driven insights to improve productivity.
However, healthcare data is a double-edged sword. For every benefit, there is a risk that inefficient, poorly protected systems will lead to negative patient or institutional outcomes.
You don’t want your medical software developers adding to these risks. But how do you know a vendor handles data properly? You don’t have the resources to audit every vendor’s IT infrastructure, much less its cybersecurity practices. Fortunately, independently-audited certifications can ease your concerns about a developer’s trustworthiness.
Key takeaways
- Third-party software developers could increase your healthcare institution’s cybersecurity, productivity, and compliance risks.
- Evaluate potential vendors for their ability to protect data privacy, security, and integrity while ensuring interoperability with your healthcare systems and the quality of their products.
- Certifications make evaluating potential developers easier by demonstrating their conformance to standards and best practices.
Data risks in healthcare software
Managing risks in your network architecture is hard enough, but adding third-party applications magnifies your exposure to cybersecurity, productivity, and compliance risks.
The early 2024 attack on UnitedHealth Group’s Change Healthcare showed how far-reaching third-party breaches can be. Threat actors target software developers to bridge into more lucrative targets like hospitals and laboratories.
Attacks on developers can use familiar techniques like phishing. They can also use more subtle techniques like compromising open source code the developer uses in its software. A developer’s cybersecurity practices directly impact your cyber risks.
A vendor’s development practices can also introduce operational risks. If the software doesn’t exchange data reliably with your existing infrastructure, it will undermine data quality and may misinform administrators or personnel at the point of care.
These cybersecurity and operational risks could put your institution at risk of violating data regulations with the resulting financial, legal, and reputational implications.
Risk criteria for choosing healthcare software developers
To manage your third-party risk, you must understand five ways a software developer manages its own risks.
- Privacy: A developer must understand the importance you place on preserving patient privacy. If it handles any protected health information (PHI), then it must have systems to prevent unauthorized access. In addition, the developers’ programmers must understand how to build privacy protections into the software.
- Cybersecurity: A software developer’s IT infrastructure must have adequate cybersecurity systems to prevent unauthorized access and quickly respond to breaches. As with privacy, the developer’s software must have internal security controls and integrations with your existing security stack.
- Data integrity: Tracking changes protects the integrity of healthcare data. Third-party software must have change management features that document alterations and who makes the changes.
- Interoperability: Third-party software must integrate with your existing systems by adopting standard protocols and data formatting conventions. This is the only way to ensure data quality so administrators and physicians can make effective decisions.
- Software quality: Finally, you must be confident in a developer’s commitment to quality throughout the software product lifecycle. This means knowing it has development and maintenance practices that ensure privacy, security, integrity, and interoperability.
Key data security and quality certifications
Evaluating every potential software vendor’s ability to meet these criteria would require dedicating expert staff to crawl through every aspect of every vendor’s business. Certifications provide a reliable shortcut early in your evaluations.
When independent auditors certify a vendor’s compliance with national regulations or internationally recognized standards, you know the developer has met a threshold for protecting your sensitive healthcare data.
Here are a few certifications your software developers should provide:
1. Privacy standards – Given the seriousness of regulatory violations, your software vendor must show it can comply with your national healthcare privacy regulations. The United States, for example, requires compliance with the Health Insurance Portability and Accountability Act (HIPAA). Penalties for HIPAA violations can reach as high as $1.5 million per year per violated provision.
A software developer with third-party certificates of HIPAA compliance will have safeguards to guarantee PHI integrity and privacy.
2. Cybersecurity standards – Software developers should also have certifications demonstrating they follow cybersecurity best practices appropriate to their size and risk exposure.
At a minimum, compliance with voluntary standards like the United Kingdom’s Cyber Essentials Scheme shows a vendor has protections against the most common forms of cyberattack. Companies receive a base-level Cyber Essentials certificate by submitting a self-evaluation for review by an independent assessor. A successful on-premise audit will yield a Cyber Essentials Plus certificate.
When considering a large developer for more critical applications, you should expect its information security management system to comply with the ISO/IEC 27001:2022 standard. More comprehensive than Cyber Essentials, this internationally-recognized standard requires your software vendor to apply risk-based data management and cybersecurity best practices.
3. Med tech standards – Look for certifications that document a developer’s ability to build applications to meet your data integrity, interoperability, and development quality criteria.
For instance, data processing systems in the American healthcare industry must comply with the Food and Drug Administration’s 21 CFR Part 11 data integrity regulations. These rules govern how developers control, validate, and audit changes within their systems.
Certification to industry standards demonstrates your developer’s ability to integrate software within your information architecture. Health Level Seven (HL7) certification shows software can exchange clinical data consistently with other systems. Digital Imaging and Communications in Medicine (DICOM) certification does the same for medical imaging devices and software they interact with.
IEC 62304 certification is particularly useful for evaluating a vendor’s software development practices. Compliance with IEC 62304 shows the developer has quality management processes throughout the software lifecycle, from initial coding to maintenance and updates.
Conclusion
When choosing the software development company for the healthcare organization it is important that you sign a contract with a company that conforms to the healthcare, privacy, and cybersecurity standards that matter to you. Their certification portfolio should demonstrate a commitment to excellence and trustworthiness, verified by third-party auditors, which can ease the challenges of choosing a healthcare software developer.
Photo: zhaojiankang, Getty Images
Alexander Podgornyy is the Founder and Managing Director of IT Medical, a custom software and AI-powered solutions developer exclusively for the Healthcare Sector. Alexander has over a decade of experience in software development and product engineering with a deep background in Healthcare IT and the cybersecurity protocols that help achieve superior productivity within medical institutions of any size without compromising on data safety and privacy.
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