Digital healthcare has been developing rapidly during the last decade: the enactment of the American Reinvestment and Recovery Act (ARRA) in 2009 drove the majority of healthcare organizations in the US to adopt the EHR system, the COVID-19 pandemic boosted telehealth apps’ popularity, and the rapid adoption of sophisticated generative AI during the past couple of years helped virtual health assistance to become a new trend.
While such progress is undoubtedly beneficial for patients and providers, there are also downsides associated with healthcare data circulating in cyberspace. The cost of data breaches in healthcare was twice as high as in any other industry between 2022 and 2023, according to Statista. Therefore, healthcare software development still has challenges to overcome in 2024, mainly in terms of regulatory compliance and strengthening security.
Healthcare software development regulations to consider
The healthcare software regulatory landscape is full of nuances. Therefore, healthcare organizations should always consult an expert before implementing a new solution, modernizing legacy systems, or integrating their software with third-party apps.
In general, a combination of laws and standards that a healthcare app should adhere to depends on the intended purpose of the software use, the type of data it will collect, process, and store, and the geographical location of the healthcare services provider and its patients.
Global security regulations relevant to healthcare software implementation
ISO 13485 and IEC 62304. These standards focus on quality management of the medical device software development process, providing software developers and healthcare device manufacturers with a set of requirements for handling the entire software lifecycle. These rules about how software for medical devices should be designed, implemented, and maintained help strengthen the cybersecurity for software that qualifies as a medical device (SaMD) and software that will be embedded into medical devices.
HL7 (Health Level Seven). This collection of industry-wide standards regulates how clinical and administrative data gets transferred between applications. It lays the foundation of healthcare software interoperability and secure data transfer.
NIST Cybersecurity Framework. This framework provides guidance for managing cybersecurity risks. It is not mandatory, but is used by experienced healthcare app developers, because it outlines the essential practices to keep software secure.
Location-specific standards
In addition to general rules for securely developing and implementing the applications that process patients’ personal information, most countries have their regulations on such software’s development and usage:
HIPAA. The Health Insurance Portability and Accountability Act is a comprehensive set of standards for protecting the privacy and security of patients’ information. Any software used by patients or clinicians in the US that handles patients’ personal health information, must be designed and implemented according to HIPAA.
CCPA. The state of California has an additional privacy protection standard – the California Consumer Privacy Act – that requires companies to disclose how they acquire, store, and share their customers’ data. Healthcare providers operating within the state have to abide by this law.
GDPR. General Data Protection Regulation sets strict rules necessary for the personal data protection of European Union citizens. Healthcare software that handles patient data and is used in the EU falls under this standard.
EU MDR (Medical Device Regulation). This regulation outlines essential safety and performance requirements for medical devices sold in the European Union. Naturally, it includes cybersecurity requirements for software as a medical device that will be used inside the EU.
PDPA. In Saudi Arabia, all operations with personal data, including those performed by healthcare organizations, are regulated by the Personal Data Protection Act. It is a broad framework that lays the foundation for data security in Saudi Arabia.
SEHR. Another Saudi Arabia regulation essential for data protection in the healthcare sector is Saudi Electronic Health Record Framework. It sets security standards specifically for the implementation and use of the EHRs.
Challenges of implementing secure healthcare software
Due to multiple standards determining the rules for safe and secure healthcare application implementation, healthcare providers often struggle to adopt sufficiently secure solutions. Software providers and consultants can help them overcome challenges that depend on the following factors:
- Number and complexity of regulations. Companies operating in multiple countries or states must navigate across and meet different international, national, and regional standards. Healthcare software consultants can assess the particular company’s type of practice, location, patient base, and other parameters to help choose the solution that fits the relevant regulatory landscape.
- Regulations’ constant evolution. While the fact that healthcare regulations are constantly transforming to adapt to the modern state of the industry is undoubtedly a positive one, it creates additional difficulties for healthcare service providers and software developers. They must constantly stay updated on the changes and adapt their software and practices accordingly. To manage this effectively, employing tools like task timers can significantly aid in efficiently allocating time to monitor and integrate these regulatory changes. It is not an easy task, and it is costly too, especially for large corporations with complex IT ecosystems in place. It’s best to partner with a software provider that offers comprehensive support services and can help with ongoing software improvements and upgrades.
- Tug between security and usability. Robust security measures put in place to meet stringent security regulations can be overwhelming for healthcare personnel and patients using the software. Healthcare software must be designed to strike a balance between supplying users with intuitive interfaces, enabling smooth workflows, and ensuring the safety and security of sensitive information and operations.
- Integration with existing systems. Many healthcare organizations have complex legacy systems. Integrating new apps securely with these systems can be challenging, requiring careful data mapping, access control measures, and adherence to interoperability standards. Healthcare organizations can navigate this process better with the help of seasoned integration consultants.
- Limited resources. Smaller healthcare providers often have limited budgets and IT staff, making investing in top-notch security solutions and expertise challenging. They have to determine the possible security breach points in their organization to address the most pressing problems first, and consider cheaper alternatives that don’t compromise security, for example, open-source secure solutions. Implementation service providers help healthcare organizations to find the cheapest solution without cutting off too much of the systems’ capabilities in the name of security.
In conclusion
Keeping sensitive healthcare data safe while providing medical personnel and patients with the convenience and comfort of digital healthcare requires a joint effort. On the one hand, software providers must consider industry specifics during the software development to deliver applications that are secure by design. At the same time, healthcare organizations must implement special measures to secure their entire ecosystem. They must adopt proper data governance strategies, enhance personnel and patients’ cyber literacy, and enforce security procedures in everyday operations.
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