July 10, 2023
How to build a medical software infrastructure: everything you need to know
Building a medical software infrastructure involves several core elements that need to be considered for it to operate effectively and securely.
And the first core element to consider is Interoperability.
Interoperability in medical software infrastructure is a critical factor in facilitating seamless communication and collaboration between different systems and software applications in the healthcare sector.
Why is Interoperability so important?
Enhanced Care Coordination
Through the availability of data, medical practitioners can readily access a patient’s crucial health records. This data accessibility could result in fewer duplicate tests, help avoid unintentional treatment interferences, and decrease communication errors.
The ease of data amalgamation directly contributes to its ease of analysis. Interoperability allows healthcare institutions to examine data trends and past performance, enabling them to make data-driven enhancements in patient care and other sectors.
Data interoperability has the potential to diminish redundant administrative tasks within and across organizations. This streamlining leads to more satisfying experiences not only for employees but also for the individuals they cater to.
Interoperability allows different software systems to “speak the same language”, improving overall efficiency and effectiveness. The 2 key concepts of interoperability are Protocols and Formats.
Protocols include email, FTP, HTTP, REST APIs, etc., and are a way of sending info from A to B.
Formats represent the information you are going to exchange. Certain formats can be relevant for a series of completely independent and unrelated protocols.
In terms of format, there are several contenders. One of the most prominent ones is FHIR.
FHIR is a way to represent medical info to exchange it. It is a verbal format that consolidates a lot of information in a single document with the aim of making it a self-contained piece of information that’s easily exchangeable without references to external resources.
That means FHIR has never been meant as a storage format. It’s inefficient for storing information and very complicated to manipulate for developers. Nonetheless, FHIR is a very complete, very versatile, and very verbose format to exchange medical information.
The iCure way: While building our IT infrastructure, we made the design decision not to store the information in the FHIR format. We use a much simpler low-level format, but we make sure that on any point, we have a bi-directional correspondence between FHIR and our internal format.
Security in medical software infrastructure is vital in maintaining the trust and safety of healthcare providers and patients alike.
With the Digital Transformation in healthcare, sensitive data such as patient records, treatment plans, and billing information are stored and transferred digitally, making them potential targets for cyber threats.
Security, in this case, pertains to measures taken to protect these health information systems against threats and attacks, ensuring the confidentiality, integrity, and availability of data.
Encryption technologies, secure communication protocols, regular software updates, and the implementation of strong access controls are all strategies used to enhance the security of medical software infrastructure.
The iCure way: You can achieve better security by putting it at the very center of your design. That’s exactly what we did with iCure. When we created iCure, we decided on 3 major design decisions:
It’s going to be distributed and possible to sync in a P2P fashion so that doctors can have data ownership.
The data is to be encrypted, with the whole design being built around the possibility of encrypting while still sharing the information.
The “Trust no one” rule is in place, so the only way you can be trusted is when it’s impossible to ‘eavesdrop’ on the data.
Compliance is a cornerstone in ensuring that healthcare systems and applications adhere to established legal, regulatory, and best practice standards aimed at safeguarding patient data and privacy.
In many countries, compliance is not merely a choice but a legal obligation.
For instance, in the United States, the Health Insurance Portability and Accountability Act (HIPAA) sets forth strict regulations to ensure the privacy and security of patient health information. Similarly, the European Union’s General Data Protection Regulation (GDPR) has provisions that apply to the handling of personal health data.
Compliance entails adherence to such laws and regulations and often involves implementing technical, physical, and administrative safeguards to protect health information.
A major aspect of compliance in medical software infrastructure involves ensuring that the software systems are designed and operated in a manner that guarantees the confidentiality, integrity, and availability of patient data. This includes employing encryption for data in transit and at rest, implementing robust authentication and authorization mechanisms, and conducting regular audits and risk assessments. Moreover, many regulations mandate that healthcare providers must enter into agreements with their vendors (such as Business Associate Agreements under HIPAA) to ensure that the vendors themselves are compliant and do not put patient data at risk.
However, maintaining compliance in medical software infrastructure is an ongoing and dynamic process. As technologies evolve, so do the threats and vulnerabilities associated with them. It is critical for healthcare organizations to stay abreast of changes in both the technological landscape and regulatory environment. Continuous training and education programs for staff, coupled with periodic review and updating of policies and procedures, are essential components of a comprehensive compliance strategy. Additionally, as healthcare systems increasingly adopt cloud services and mobile technologies, they must also consider the compliance implications of these technologies and ensure that they are integrated in a manner that aligns with regulatory requirements and best practices.
The iCure way: We believe compliance is the bare minimum if we talk about medical software infrastructure.
Scalability in medical software infrastructure refers to the ability of a system to handle an increasing amount of work or its potential to accommodate growth. In healthcare, scalability is of paramount importance due to the ever-evolving nature of the industry.
As healthcare providers continue to integrate technology into their practices, they experience an influx of data from electronic health records (EHRs), medical imaging, remote patient monitoring systems, and other sources. Scalability ensures that the infrastructure can handle this increase in data volume without performance degradation, enabling healthcare organizations to deliver services to a growing number of patients timely and efficiently.
One of the critical aspects that contribute to scalability is the flexibility and adaptability of the infrastructure to accommodate various forms of data and communication protocols. In the context of healthcare, this means the infrastructure must not only be capable of handling large volumes of data but also manage different data types, such as structured and unstructured data.
The integration of standardized APIs and adherence to interoperability standards, such as FHIR, can significantly improve the system’s capability to interface with multiple sources of data, thus improving scalability.
Additionally, the advent of cloud computing has provided a significant boost to scalability in medical software infrastructure. With cloud-based solutions, healthcare organizations can scale their operations efficiently and effectively without the need for substantial upfront investment in hardware.
This model, often referred to as infrastructure as a service (IaaS), allows organizations to add resources dynamically based on demand. Consequently, healthcare providers can respond swiftly to changes, such as sudden increases in patient numbers during pandemics or the rapid adoption of telemedicine, without the worry of overburdening their existing infrastructure.
The iCure way: Another thing that we put at the center of the design was scalability. We started with 180 doctors and 200,000 patients using our solutions. Right now, it’s 3,000 doctors and 4m patients, though we didn’t change a thing in design. Scalability was the cornerstone, so we counted on it.
Another principle we’ve built iCure on was the CIA Triad of the data.
The CIA triad is a widely-recognized information security model that stands for Confidentiality, Integrity, and Availability. It serves as a guideline for policies and procedures aimed at securing data.
Confidentiality ensures that data is only accessible to authorized individuals, typically achieved through encryption and access controls. Integrity involves maintaining and ensuring the accuracy and reliability of data throughout its lifecycle and includes mechanisms such as checksums and data validation to detect any unauthorized alterations. Availability ensures that data is accessible when needed by authorized users, which is vital for the smooth operation of systems and services.
The CIA triad is fundamental to creating a secure environment for data storage, processing, and transmission.
The iCure way: The confidentiality of iCure was guaranteed by having true E2E encryption by design. We guaranteed Integrity by using a distributed system where lots of copies of the information are going to exist, being updated in real time. And Availability is guaranteed by having a very scalable system with no single point of failure. The key here is to integrate these constraints into the lower layers of your design (instead of putting them on top of everything in the end).
In conclusion, building a medical software infrastructure is an intricate yet essential undertaking that can significantly transform healthcare delivery.
By focusing on interoperability, security, compliance, scalability, and employing the CIA triad principles, organizations can create robust systems that not only streamline operations but also enhance patient outcomes. It’s vital to recognize that the healthcare landscape is continuously evolving, and as such, a medical software infrastructure should be adaptable and future-proof.
Additionally, collaboration among stakeholders, including healthcare providers, software developers, regulatory bodies, and patients, is key to addressing challenges and leveraging opportunities.
Ultimately, a well-designed medical software infrastructure can be instrumental in advancing healthcare towards a more efficient, integrated, and patient-centric model, one that capitalizes on data-driven insights for better decision-making and improved overall public health.