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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.

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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.

  • Improved Performance

    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.

  • Superior Experiences

    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.

2. Security

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.

3. Compliance

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.

4. Scalability

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.

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www.iCure.com

1. RECITALS

ICure SA is incorporated in Geneva, Switzerland, with a registered office at Rue de la Fontaine 7, 1211 Geneva, Switzerland registered in the commercial registry under CHE-270.492.477 (“iCure”).

These Terms of Use constitute a legally binding agreement made between you, whether personally or on behalf of an entity (“you”) and iCure SA (“we,” “us” or “our”), concerning your access to and use of the https://www.icure.com website as well as any other media form, media channel, mobile website or mobile application related, linked, or otherwise connected thereto (collectively, the “Website”).

When you accept, these Terms form a legally binding agreement between you and iCure. If you are entering into these Terms on behalf of an entity, such as your employer or the company you work for, you represent that you have the legal authority to bind that entity.

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The original language of these Terms and Use is English. In case of other translations provided by iCure, the English version shall prevail.

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4. PROHIBITED ACTIVITIES

You may not access or use the Website for any purpose other than that for which we make the Website available. The Website may not be used in connection with any commercial endeavors except those that are specifically endorsed or approved between you and iCure.

As a user of the Website, you agree not to:

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In no event shall iCure, nor any of its officers, directors, and employees shall be held liable for anything arising out of or in any way connected with your use of this Website whether such liability is under this agreement. iCure, including its officers, directors, and employees shall not be held liable for any indirect, consequential, or special liability arising out of or in any way related to your use of this Website.

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You hereby fully indemnify iCure from and against any and/or all liabilities, costs, demands, causes of action, damages, and expenses arising in any way related to your breach of any of the provisions of these Terms.

8. SEVERABILITY

If any provision of these Terms is found to be invalid under any applicable law, such provisions shall be deleted without affecting the remaining provisions herein.

9. VARIATION OF TERMS

iCure is permitted to revise these Terms at any time as it sees fit, and by using this Website you are expected to review these Terms on a regular basis.

10. ASSIGNMENT

iCure is allowed to assign, transfer, and subcontract its rights and/or obligations under these Terms without any notification. However, you are not allowed to assign, transfer, or subcontract any of your rights and/or obligations under these Terms.

11. ENTIRE AGREEMENT

These Terms constitute the entire agreement between iCure and you in relation to your use of this Website and supersede all prior agreements and understandings.

12. GOVERNING LAW & JURISDICTION

These Terms shall be governed by and construed in accordance with the laws of Switzerland, without regard to its conflict of law provisions.

The parties shall attempt to solve the matter amicably in mutual negotiations. In case of a non-amicable settlement that has been found between the parties, the Court of Geneva will be competent.

13. PRIVACY

Please refer to our Privacy Policy and Cookie Notice for the Data that we collected from the contact form and the Matomo cookie.

iCure SA

Contact: contact@icure.com

Last update: November 2nd, 2022.

Privacy Policy

www.iCure.com

iCure SA (iCure) is incorporated in Geneva, Switzerland, with a registered office at Rue de la Fontaine 7, 1204 Geneva, Switzerland registered in the commercial registry under CHE-270.492.477.

This Privacy Policy describes the information that we collect through our Website (https://www.icure.com), how we use such information, and the steps we take to protect such information. We strongly recommend that you read the Privacy Policy carefully.

BY VISITING THE WEBSITE, YOU ACCEPT THE PRIVACY PRACTICES DESCRIBED IN THIS PRIVACY POLICY. IF YOU DO NOT ACCEPT THE TERMS OF THE PRIVACY POLICY, YOU ARE DIRECTED TO DISCONTINUE ACCESSING OR OTHERWISE VISITING THE WEBSITE.

The original language of this Privacy Policy is English. In the case of other translations provided by iCure, the English version shall prevail.

This Privacy Policy is incorporated into and is subject to, the iCure Terms of Use.

1. Definitions

Administrative Data: means Personal Data such as the Name, Email, and Phone in order to perform administrative tasks like Invoicing or contacting the Client (if support is needed).

Cookies: means text files placed on a computer to collect standard internet log information and visitor behavior information. When you visit a website, they may collect information from a computer automatically through cookies or similar technology (for further information please refer to our Cookies Notice, visit allaboutcookies.org.).

Data controller: means the natural or legal person, public authority, agency or other body which, alone or jointly with others, determines the purposes and means of the processing of personal data; where the purposes and means of such processing are determined by Union or Member State law, the controller or the specific criteria for its nomination may be provided for by Union or Member State law.

Data processor: means a natural or legal person, public authority, agency or other body which processes personal data on behalf of the controller.

Personal Data: means any information relating to an identified or identifiable natural person (‘data subject’); an identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person.

Processing: means any operation or set of operations which is performed on personal data or on sets of personal data, whether or not by automated means, such as collection, recording, organisation, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction.

Visitor: means the natural person that submits their Personal Data through our contact form; and/or sends us an email; and/or cookies have been implemented.

All other undefined terms used in this Agreement have the meaning from our Terms and Conditions and the General Data Protection Regulation of the Regulation (EU) 2016/679 of 27 April 2016 (GDPR).

2. Concerning your Personal Data

For this website, iCure collects and determines the use and the purpose of any Personal Data uploaded by the visitor, therefore iCure is defined as the Data Controller according to the GDPR.

2.1 Contact Form

iCure collects Administrative Data that the Visitor completed in our contact form available through our Website.

The Administrative Data that Visitor provides to iCure on this contact form are the First name, the last name, the working e-mail address, the name of your organization, and other Personal Data that the Visitor included in the description of its work.

iCure processes these Administrative Data on the lawful basis of the Visitor’s consent (Article 6, 1. a) of the GDPR).

iCure uses these Administrative Data to perform administrative tasks like contacting the Visitor who completed the contact form, to better understand your needs and interests, and to provide you with better service.

2.2 Email

The Visitor can contact iCure through contact@icure.com to get any information about the Company or new job positions. In this email, the Visitor includes his Name, mail address, and any other Personal Data.

iCure processes these Personal Data on the lawful basis of the Visitor’s consent (Article 6, 1. a) of the GDPR).

iCure uses these Personal Data to answer any request from the Visitor and to consider the Visitor’s job application that they sent us by email.

2.3 Newsletters

iCure offers newsletters to provide you with updates, promotional communications, and offers related to our products and services. If you wish to receive our newsletters, we will collect and process your Personal Data for this specific purpose.

iCure processes these Personal Data on the lawful basis of the Visitor’s consent (Article 6, 1. a) of the GDPR). By subscribing to our Newsletters, you explicitly consent to the use of your Personal Data for direct marketing purposes, including the sending of promotional communications and offers by email.

If you do not want your Personal Data to be further processed for direct marketing purposes, you have the right to withdraw your consent at any time, free of charge and without having to provide any justification, by contacting iCure.

3. Security

iCure has implemented appropriate technical and organizational measures to safeguard your Personal Data against any accidental or illicit destruction, loss, modification, deterioration, usage, access, divulgation, and any other unauthorized processing of your Personal Data. We make every effort to protect personal information. However, you should always be careful when you submit personal or confidential information about yourself on any website, including our website.

4. The data retention period and the conditions for deletion

iCure will not retain your Personal Data, as collected, and processed in accordance with this Privacy Policy, for a period longer than necessary to fulfill the purposes described above.

For the Administrative Data from the contact form completed by the Visitor (as described in section 2.1 of this Privacy Policy), these Data shall be stored for a maximum period of 1 month from the completion of the form.

For the Personal Data from the Email completed by the Visitor (as described in section 2.2 of this Privacy Policy), these Data shall be stored for a maximum period of 2 months from the completion of the form.

For the Personal Data from the Newsletters completed by the Visitor (as described in section 2.3 of this Privacy Policy), these Data shall be stored for a maximum period of 11 months from the date of your consent or until you withdraw it.

5. Your rights

You are entitled to access your Personal Data processed by iCure and request their modification or erasure if it is incorrect or unnecessary. To exercise your rights, you may get in touch with iCure by using the electronic contact form available on our website or send a written and signed request to iCure at the email address privacy@icure.com with a copy of your ID or other identification documents, and any document proving that you are the data subject.

In general, where applicable, you also have the right to withdraw consent to the processing at any time. This withdrawal does not affect the lawfulness of processing based on consent made prior to such withdrawal. In certain cases, you also have the right to data portability. Those rights can be exercised by following the abovementioned procedure.

You have the right to lodge a complaint with a supervisory authority, in the Member State of the European Union of your usual place of residence, your place of work, or the place where the violation occurred, if you consider that the processing of personal data relating to you infringes Data Protection Law.

Please, note that the term of processing of such request can take up to one month. Contact: privacy@icure.com

6. Modification

iCure expressly reserves the right to modify this Privacy Policy and you undertake to regularly review the Privacy Policy. By amending the Privacy Policy, iCure will consider your legitimate interests. You will receive a notification if the Privacy Policy is modified. By continuing to actively use the iCure Services after such notification, you acknowledge that you have read the modifications to the Privacy Policy.

7. Information Sharing

Our employees and/or authorized contractors are the people in charge of the Data Processing.

iCure does not sell, rent, or lease any individual’s personal information or lists of email addresses to anyone for marketing purposes, and we take commercially reasonable steps to maintain the security of this information.

However, iCure reserves the right to supply any such information to any organization into which iCure may merge in the future or to which it may make any transfer in order to enable a third party to continue part or all of its mission.

We also reserve the right to release personal information to protect our systems or business when we reasonably believe you to be in violation of our Terms of Use and Privacy Policy or if we reasonably believe you to have initiated or participated in any illegal activity.

In addition, please be aware that in certain circumstances, iCure may be obligated to release your personal information pursuant to judicial or other government subpoenas, warrants, or other orders.

8. Links to other Websites

This Website may provide links to third-party websites (Instagram and Linkedin) for the convenience of our users. If you access those links, you will leave this website. iCure does not control these third-party websites and cannot represent that their policies and practices will be consistent with this Privacy Policy. For example, other websites may collect or use personal information about you in a manner different from that described in this document. Therefore, you should use other websites with caution and do so at your own risk. We encourage you to review the privacy policy of any website before submitting personal information.

9. Cookies

To get more information on how iCure uses Matomo’s cookies, please check our Cookie Notice.

10. Contact

Please contact us with any questions or comments about this Policy, your Personal Data, and our use and disclosure practices by email at privacy@icure.com If you have any concerns or complaints about this Policy or your Personal Data, you may contact our DPO at privacy@icure.com.

Please, note that the term of processing of such request can take up to one month.

iCure SA

Contact : privacy@icure.com

Last update: July the 26th, 2023.

Information Security Policy

www.iCure.com

1. Introduction

The iCure universe is built on trust. Guaranteeing the confidentiality of the data that are entrusted to us is our highest priority.

The Information Security Policy of iCure abstracts the security concept that permeates every activity and abides by the ISO 27001:2013 requirements for Information Security, so that we ensure the security of the data that iCure and its clients manage.

Every employee, contractor, consultant, supplier and client of iCure is bound by our Information Security Policy.

2. Our Policy

iCure is committed to protecting the confidentiality, integrity and availability of the service it provides and the data it manages. iCure also considers protecting the privacy of its employees, partners, suppliers, clients and their customers as a fundamental security aspect.

iCure complies with all applicable laws and regulations regarding the protection of information assets and voluntarily commits itself to the provisions of the ISO 27001:2013.

3. Information Security Definitions

Confidentiality refers to iCure’s ability to protect information against disclosure. Attacks, such as network reconnaissance, database breaches or electronic eavesdropping or inadvertent information revealing through poor practices.

Integrity is about ensuring that information is not tampered with during or after submission. Data integrity can be compromised by accident or on purpose, by evading intrusion detection or changing file configurations to allow unwanted access.

Availability requires organizations to have up-and-running systems, networks, and applications to guarantee authorized users’ access to information without any interruption or waiting. The nature of data entrusted to us requires a higher-than-average availability.

Privacy is the right of individuals to control the collection, use, and disclosure of their personal information. Our privacy policies are based on the GDPR(https://gdpr-info.eu/) and can be augmented by added requirements of specific clients or law areas.

4. Risk Assessment

The main threats iCure is facing as a company are:

  1. Data Theft;
  2. Data Deletion;
  3. Denial of Service attacks;
  4. Malware;
  5. Blackmail and Extortion.

As providers of a solution used by developers active in Healthcare, we also have to anticipate the risks of:

  1. Attacks on our clients’ data, which could lead to major social damages and a loss of trust in our solution;
  2. Abuse of our solution by ill-intentioned clients, that could impact the quality of the service provided to the rest of our clients.

The motivation of the attackers in the latter cases can range from financial gain to political or ideological motivations.

A last risk is linked to the nature of the healthcare data we handle. We must ensure, that the data we handle are not used for purposes other than those for which they were collected:

A piece of data collected from a patient for the purpose of a medical consultation should not be available to third parties, not even a government agency.

5. Risk Management

The main principles we apply to manage the risks we face are:

  1. Confidentiality by design: All sensitive data is encrypted end-to-end before being stored in our databases. We do not have any access to the data we store. Our client’s customers are the only ones who can decrypt the data we store.
  2. Anonymization by design: Healthcare information that has to be stored unencrypted is always anonymized using end-to-end encryption scheme. This means that the link between the healthcare and administrative information must be encrypted.

Those two principles allow us to minimize the risks of data theft, blackmail, extortion, and coercion by government agency.

  1. Multiple real-time replicas, with automatic failover: We use a distributed database architecture to ensure that our data is available at all times. We use a master-master architecture, each data is replicated at least 3 times. Snapshots are taken every day to ensure that we can restore the data in case of a malevolent deletion event.
  2. Automatic password rotations: no single password can be used for more than 48 hours. Passwords are automatically rotated every 24 hours. In case of a password leak, we can limit the window of opportunity for an attack.

Those two principles allow us to minimise the risks of data deletion, denial of service attacks, and malware.

  1. Minimization of the attack surface: we deploy our systems in the most minimal way. We only expose the network services that are strictly necessary.
  2. Strict dependency management: we only use open-source software that is regularly updated and audited by the community. We favor dependency management software and providers that minimize the risk of supply chain poisoning.

Those two principles allow iCure to minimise the risks of intrusion by vulnerability exploit or supply chain attacks, two risks that could lead to data theft or data deletion.

6. Further Information

This policy is valid as of November 10th, 2022. For futher information please connect with us at privacy@icure.com

Impressum

iCure SA

Rue de la Fontaine 7, 1204 Geneva, Switzerland

CHE-270.492.477

Website: https://icure.com/

Contact email: client@icure.com

Privacy request: privacy@icure.com

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www.iCure.com

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The user can, at any time, allow, block or delete the cookies installed on his/her device by changing the settings on the browser installed on his/her computer:

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  • Firefox Firefox: Tools – > Options -> Privacy -> History -> Customised Settings. For more information, consult Mozilla support or your browser Help
  • Safari Safari Preferences -> Security. For more information, consult Apple support or your browser Help.
  • You will not access the Website through automated or non-human means, whether through a bot, script, or otherwise.
  • You will not use the Website for any illegal or unauthorized purpose.
  • Your use of the Website will not violate any applicable law or regulation.

6. Withdrawing consent

The user may withdraw his/her consent relating to the Cookies Policy at any time, and may delete the cookies stored on his/her device by adjusting his/her internet browser settings, as described above.

7. Cookie settings

This Cookies Policy may be modified when required by the legislation in force at any time or when there is a change in the type of cookies used on the website. For this reason, we recommend that you review this policy every time you access our website so that you are appropriately informed of how and why we use cookies.

8. Contact

Please contact us with any questions or comments about this Policy, your Personal Data, and our use and disclosure practices by email at privacy@icure.com

iCure SA

Contact: contact@icure.com

Last update: September 13th, 2023