Yes, every reading action is recorded. This allows the pregnant woman to see who has viewed what information. If she does not agree, she can ask for justification.
The pregnant woman decides who is allowed to see what, and when. She may be assisted in this by a care provider, for instance if she cannot or does not want to determine herself, but ultimately the pregnant woman decides. Sharing information can help when a pregnant woman is referred to another care provider. But if the pregnant woman decides that the information must not be shared, no one is allowed to view the data. The consequence is then that the pregnant woman must share all the information herself with the other health care provider. But that is her own choice in that case.
The information is managed by the healthcare provider and the pregnant woman. The information is contained in small data files. These datafiles are located in different places, invisible to the outside world and only accessible according to a register. The register states where you can find what.
The register is located within the healthcare network, which is both physically and legally secure. The healthcare provider adds information, the pregnant woman decides who can see what and when.
Access to the data is protected through consent rules (APPC) and complies with NEN7510. Access to the register is protected by IT techniques (secure network, firewalls, ports, etc.).
The information is only accessible via a secure healthcare network, which includes the register, which can only be accessed by authorised healthcare providers. The register does not contain any information. It only states where information can be found. These are the repositories. The repository contains small data files, the so-called healthcare information building blocks. The information in a data file is encrypted and only readable with a key. By collecting different information building blocks and combining them, a readable whole is created.
Before the file is stored, it is encrypted with a unique key that has been determined by the pregnant woman when she identified herself, for example by DigiD or Idensys or other techniques. With the same key, the data is also decrypted before it is presented. The data is transported between the various systems according to end-to-end encryption.
The consent (the pregnant woman's permission) is recorded in the XDS environment. This can be entered in various ways; by the pregnant woman herself, via an app, by the care provider, after verbal consent by the pregnant woman, directly into the XDS environment, or by the care provider in its own healthcare system, after which it is processed in the XDS environment. The pregnant woman can see who has read which information and when.
The CareCodex Foundation continues to work with other parties on increasingly sophisticated methods of ensuring security.
If you want to participate in the pilots, please contact the CareCodex Foundation. Also if you have more questions or would like to receive more information we would like to hear from you.
In the period from June 2016 to January 2017, work on the so-called 'Proof of Concept' was carried out in three Obstetric Collaborations (VSVs). These are the regions: Amsterdam East-Centre, Amsterdam West and Hoorn. These regions have now also been registered as pilot regions for the implementation.
The concept has been designed, the concept has been proven, it is now time to start a pilot with three ESLs after which the application can be implemented in the following ESLs.
Six levels have been designed for the implementation of the integral file. The name 'level' means: the total of available functions in the relevant phase.
The first step in the realisation phase is to implement a live file in the three pilot regions; first in Amsterdam East-Centre and Amsterdam West, and then in the Hoorn region.
Within a period of two months, a so-called 'level 1' file will be implemented in Amsterdam. This is a limited file in which the care network and XDS have been set up, but the documents have not yet been combined into, for example, an integrated pregnancy chart.
At the same time, preparations will be started for the implementation of level 2 in Hoorn. In level 2, there is an integral pregnancy map. For the implementation of level 2 in Hoorn it is estimated that a period of about five months will be needed. At the moment that level 2 is implemented in Hoorn, the level 2 file can also be taken into use in Amsterdam. For the long term, six levels are foreseen.
At each level, the implementation document is expanded and improved, and can then be applied to the implementation of subsequent ESLs.
At the moment, the list of the following ESLs is not yet known.
The secure networks charge a subscription fee for access to the network. The registry is located within the network and the costs of the registry are paid by the manager of the network. The costs are based on the number of persons in the register. The information is retrievable without restriction (within consent). Answering the question of what the exact annual costs of this solution will be is not possible at the moment. The pilots in the coming year will provide a lot of information and insight that will make this concrete and quantifiable.
No, not always. It is precisely because of an integral file that all the patient's details are included, up to date. There may be a desire to copy data for personal administration, but this is expected to diminish as confidence grows that the required information is available. Copying is more work, is error prone, and should be marked as a copy. Otherwise, the information is presented twice in the integral file.
Importing data into one's own system is possible provided that the supplier of one's own application also builds this in. The methodology does offer this possibility.
Yes, all the actions that a pregnant woman would like to take can be taken by a healthcare professional. He can ask questions in plain language, process the answers and read out what is said. The caregiver is bound by a duty of confidentiality and is subservient to the pregnant woman.
No, the information only goes into XDS when the information has been validated. This is a decision for the healthcare provider. Of course, everyone wants things to happen as quickly as possible, but if a pregnant woman is giving birth at home, the file is not the first priority. In a normal birth, the file can then be completed afterwards.
Only in the case of an acute transfer is it desirable for the most important data to be made available immediately. But only if the pregnant woman has given her consent.
Yes, even if the pregnant woman does not visit her own healthcare provider, the provider can still access her data if the pregnant woman gives her permission. A healthcare provider can connect from his or her region to the register in another region. This will allow the healthcare provider to view the information for which consent has been given. This is also possible abroad. The information is translated so that the local healthcare provider can actually read it.
No, that is not necessary. A method has been developed whereby the information is displayed in a fixed place on a screen, on a screen per care step. With the method, different data files are combined into one screen and the information is presented in fixed places.
The care network meets the security standards according to NEN7510 and the processing of the information is carried out according to the worldwide IHE-XDS standard. Data security falls within the scope of the Personal Data Protection Act.
No, that is not necessary. Not all suppliers can, or want to, adapt the software. Therefore, a method has been developed to translate the information that is already available. In this way, software systems that are not yet able to handle XDS can still be linked up.
Zorgdomein is now used to refer a client or patient; with the referral, information about the pregnant woman is also sent. It is expected that the referral will be used for a longer period of time, because it must be legally clear who is responsible for the patient's care at any given time. The care domain referral can also be included in XDS. The extra information no longer needs to be sent along. The healthcare provider can read it in the integral file.
Healthcare mail is now used to send information to another healthcare provider. This is often plain text and medical jargon. The expectation is that this will be used less when there is an integral file. Exchanging safe questions and answers will probably always remain.
A statistics manager can only access the anonymised data. However, this is data that has the right structure and is immediately available. At the moment, the data is still received and corrected before it can be processed (cold data). With the anonymous integral file, the information is immediately available (warm data).
Within the VSV, information can be exchanged easily and quickly with consent. An integrated file means fewer data transfer errors and less administration time.
The healthcare provider works within his/her own healthcare system. Within this system, an extra tab has been added with a viewer to the data of the pregnant woman. The healthcare provider does not have to log in again or search for the pregnant woman's details. The most important retrieval data are known from his/her own screen and the retrieval function is directly logged in (single-sign-on).
The care provider sees the required information for each care step. The information is displayed in a fixed location on the screen. If more values are available for a piece of information, a message is displayed stating that there is a difference and where the differences come from. For example, a different a-terme date.
The healthcare provider receives values with a date from XDS. These values are displayed as dots in a graph and a graph line is drawn through them in the viewer. The graph shows the allowed upper and lower value. The graph also distinguishes for each value by who the value was measured. For example, the blood pressure may have been measured by the pregnant woman herself and may deviate from the value measured by healthcare providers. The healthcare provider can choose whether or not to include the different values in the graph (filter).
Information from the patient's own healthcare system is also included in the file.
The pregnant woman has access via an internet page on a PC or tablet, and/or via an app on a mobile phone or tablet. She logs in with a login and password via Idensys (or DigiD). The information about the pregnant woman is read via XDS and presented to her in her own language. No data is stored in the form of files or cookies.
It sees three main groups of information:
- her own data in the form of an integral pregnancy chart;
- the screens for consent;
- the screens with the history (who saw what and when).
In the future, the individual care plan will be added.
The research and design phase has been characterised by many spontaneous initiatives, unplanned cooperative relationships and a research and experimentation nature. Some of the initiatives were taken by Talmor and De Verbinding in close cooperation with a number of regulatory and support bodies - including Nictiz and Perined - with a number of end users, experts, suppliers and, at a later stage, with the Taskforce transitie geboortezorg. All current programmes will be involved in the realisation. Examples are "registration at source", "Medmij", "healthcare information building blocks", "PWD (unity of language)".
The concept has been designed, the concept has been proven, it is now time to start a pilot with three ESLs after which the application can be implemented in the following ESLs.
Six levels have been designed for the implementation of the integral file. The name 'level' means: the total of available functions in the relevant phase.
The first step in the realisation phase is to implement a live file in the three pilot regions; first in Amsterdam East-Centre and Amsterdam West, and then in the Hoorn region.
Within a period of two months, a so-called 'level 1' file will be implemented in Amsterdam. This is a limited file in which the care network and XDS have been set up, but the documents have not yet been combined into, for example, an integrated pregnancy chart.
At the same time, preparations will be started for the implementation of level 2 in Hoorn. In level 2, there is an integral pregnancy map. For the implementation of level 2 in Hoorn it is estimated that a period of about five months will be needed. At the moment that level 2 is implemented in Hoorn, the level 2 file can also be taken into use in Amsterdam. For the long term, six levels are foreseen.
At each level, the implementation document is expanded and improved, and can then be applied to the implementation of subsequent ESLs.
At the moment, the list of the following ESLs is not yet known.
- Existing techniques and methods are used.
- Software suppliers are asked to make adjustments, but these are minimal and preferably avoided.
- Pregnant/mother/child focus.
- The application must contribute directly to the needs of the pregnant woman; she must be in control of her own data.
- Register once at the source.
- The application should minimise the need for copying data. The data is entered by the healthcare provider concerned into its own system and is then readable by another healthcare provider (by consent). If data is already copied, it must be clear that it has been copied.
- Supporting integral cooperation.
- The application must be suitable for the Multi Disciplinary Consultation (MDO).
- Healthcare providers have and will continue to have the possibility of working in their own (current) systems.
- The application should not require the healthcare provider to work with another application. The healthcare provider is familiar with, and has confidence in, their own application.
- Solution must be sustainable: comply with (IHE) international standards and with laws and regulations.
The CareCodex concept is based on the wish that information can be found quickly, for instance in such a way that there is one screen display per care step in which all desired information is visible in a structured way. This information can come from various sources. The first basic starting point is the integral pregnancy chart.
There are three variants of 'consuming' data:
- Viewing data
- Download
- Import
For the time being, we are focusing on the viewer for the first levels (the first steps in the realisation phase). Further development for both downloading and importing is necessary.
One of the pitfalls of the possibility of exchanging information is that a large number of documents have to be gone through to find the desired information. The composition, structure and layout of the data do not yet match the wishes of the care provider in relation to the care contacts, the care steps in the client's care process.
The same can be said for the display of data and information for the patient or client themselves. With the CareCodex concept, the IHE-XDS technique is extended with additional resources, which also eliminates this disadvantage. Moreover, this provides the additional advantage that suppliers do not necessarily have to be XDS-compliant.
With the CareCodex concept, the information is collected per care step and presented in a structured manner. The care provider then knows exactly where to find which information.
Furthermore, the care providers can continue to work in the current applications that they are already used to. The transition to using this method is therefore relatively small.
A methodology using the regional registers, based on international standards according to IHE (Integrating the Healthcare Enterprise) is particularly suitable, as is the realisation of interoperability - i.e. exchangeability of patient and client information - between different domains of birth care in the Netherlands.
This means that healthcare providers from different regions can also exchange information. The IHE-XDS methodology lends itself to expansion with techniques to ensure that all suppliers can participate and that the data - regardless of how it is provided - becomes available in a selected and well-organised manner to clients/patients and healthcare providers.
The general global vision is that in the future, images and data will be shared more and more through the technique of IHE-XDS. This technique is based on the storage of documents in a relatively freely chosen location (repository) and the registration of where these documents are (registry). Documents are understood to be: photos, texts, ultrasound, X-rays, films, data, etcetera.
The CareCodex methodology is based on this and has supplemented it with solutions to secure and translate data in such a way that implementation can be accelerated and security increased.
Existing hardware is used. The repositories are located in secure networks that meet the highest standards. The repositories are located as much as possible in the same secure networks. These cannot be accessed just like that. Access is only possible from the registry.
The data in the repositories is stored encrypted. There is no data on the pregnant woman's phone or laptop. Data is stored centrally, even if it belongs to the patient or client. If the pregnant woman loses the phone, authentication of the person, number and phone must be carried out again. This is the standard method of Idensys, for example.
The most important requirements are:
- Access control, authentication and data security;
By means of identity check of the healthcare provider (e.g. UZI pass), identity check of the computer (e.g. server certificate) and identity check of the pregnant woman (e.g. DigiD and/or Idensys), consent control according to APPC standard. APPC is Advanced Patient Privacy Consents, APPC goes beyond BPPC (Basic Patient Privacy Consents). - Information for the pregnant woman, and control and direction for the pregnant woman;
The pregnant woman must be able to view her own information. The pregnant woman must be able to determine who is allowed to see what (consent), and must be able to see which care provider has seen what of her. - Support for the caregiver;
The information should quickly help the caregiver to collect and present relevant information. - Supporting the organisation;
The information should contribute to overseeing the care pathways and provide the organisation with management information. - Information for statistical managers;
It must be possible to use the information anonymously for creating statistics.
The wish is that a solution will be found whereby everyone can continue to work with their own current software system, that they can share information with each other, that the pregnant woman can view her information, that she can determine who can see what and that she can also see who has seen what, when and why.
In addition, the solution must be sustainable so that it can also be used in 20 years' time - just like the information that is currently being created - and so that it is part of all healthcare information exchange. In other words, it is about more than just information relating to pregnancy and birth. Ease of use and hence time savings are important aspects for all users. Even though everyone can get used to time-consuming and sometimes cumbersome working methods, the desire to have as much attention and time available as possible for customer contact and substantive care provision is great and only growing.
In the field of childbirth care, there is a great need for all parties involved to share patient and client information. There are plenty of indications that preventing the loss of information during the transfer of care between healthcare providers can make an important contribution to quality improvement.
The multitude of parties involved in the care of a pregnant woman means a complex network of applications that must be adequately connected in order to share information reliably, effectively and efficiently. There is a need for structured information at the right time. In short: the right information at the right time.
Several healthcare providers are involved in supporting a pregnant woman: midwives, gynaecologists, ultrasound operators, maternity nurses, lab technicians, etc.
Much of the information about the pregnant woman is not shared with other care providers or with the client or patient herself. If information is shared in the current situation, it may be sent directly by fax, by secure mail or by the pregnant woman herself (on paper). The wish to share relevant information - digitally - was expressed by both care providers and the pregnant woman herself. This prevents information from being missed at crucial moments and eliminates unnecessary duplication of work, thereby reducing errors and, consequently, incorrect information.
A prerequisite is that it is safe, that the pregnant woman's consent is required, that the pregnant woman can see who has seen what, and that the information is correct and above all legible, both for the care provider involved and for the pregnant woman. The problem here is that different healthcare providers also use different software systems, and that in a number of cases the software suppliers are unable (and sometimes unwilling) to cooperate in adapting the systems.
As a solution, it is sometimes thought of to work together in one central system, for example of a hospital, but then it must still be possible to communicate with other stakeholders. The goal was to come up with a solution that meets all these wishes and requirements.
Talmor and De Verbinding have started the initiative for an integral file for birth care.
In 2015, research was started by Talmor into the status of the PWD and the possibilities for an integrated record for birth care. After research and development of a concept, three test sessions were held in 2016 as proof of concept.
Furthermore, it is now time to determine which activities and financial flows belong to the commercial domain and which to the public domain. One of the consequences of this is that the facilitation of these developments will soon no longer be part of Talmor or De Verbinding, but will be housed in the CareCodex Foundation.
If you would like more information, please contact the CareCodex Foundation.
We are located at:
Andreas Bonnstraat 24hs
1091 AZ Amsterdam
T: 020-33 46 050
E: carecodex@carecodex.org
I: www.carecodex.org
The concept has been designed, the concept has been proven, it is now time to start a pilot with three ESLs after which the application can be implemented in the following ESLs.
Six levels have been designed for the implementation of the integral file. The name 'level' means: the total of available functions in the relevant phase.
The first step in the realisation phase is to implement a live file in the three pilot regions; first in Amsterdam East-Centre and Amsterdam West, and then in the Hoorn region.
Within a period of two months, a so-called 'level 1' file will be implemented in Amsterdam. This is a limited file in which the care network and XDS have been set up, but the documents have not yet been combined into, for example, an integrated pregnancy chart.
At the same time, preparations will be started for the implementation of level 2 in Hoorn. In level 2, there is an integral pregnancy map. For the implementation of level 2 in Hoorn it is estimated that a period of about five months will be needed. At the moment that level 2 is implemented in Hoorn, the level 2 file can also be taken into use in Amsterdam. For the long term, six levels are foreseen.
At each level, the implementation document is expanded and improved, and can then be applied to the implementation of subsequent ESLs.
At the moment, the list of the following ESLs is not yet known.
The CareCodex Foundation is a non-profit foundation that aims to improve healthcare in the Netherlands and abroad by enabling transparent, secure, digital information exchange between healthcare providers and clients/patients. The client/patient is at the top of the hierarchy of end-users and has control over his/her personal data and information, while his/her privacy and self-determination are guaranteed.
The CareCodex Foundation promotes (the improvement of) the quality of care in the Netherlands and abroad by developing, implementing and maintaining a route and methodology for the integral exchange of information between care providers and client/patient.
The foundation also aims to stimulate a living environment and develop conditions and circumstances that ensure data security, data privacy and the control thereof for individual patients and clients.