Contract on the Processing of Clinical Data and Their Transfer to a Health Sector Database - Islensk Erfoagreining ehf.
Contract on the Processing of Clinical Data
and their Transfer to a Health Sector Database
between
The [ Name of Health Institution ]
hereinafter referred to as [HI],
and
Islensk erfoagreining ehf., State Reg. No. 691295-3549, Lynghals 1, Reykjavik
hereinafter referred to as ISLENSK ERFOAGREINING;
Whereas the Minister for Health issued to Islensk erfoagreining ehf., on
22 January 2000, an Operating Licence for the Creation and Operation of a
Health Sector Database, on the basis of Act No. 139/1998, on a Health
Sector Database;
Whereas Act No. 139/1998 and the Operating Licence provide that the holder of
the Operating Licence is permitted to take delivery of data processed from
medical files for transfer to a Health Sector Database subject to the approval
of health institutions or self-employed health service workers;
Whereas the Operating Licence provides that before the commencement of transfer
of data into the Health Sector Database, the Licensee shall enter into written
contracts with the health institutions in question or self-employed health
service workers on access to information from medical records and the handling
of such information;
Whereas the [Health Institution] and Islensk erfoagreining ehf. have engaged in
negotiations and arrived at an agreement, as set out in this Contract, on the
access of Islensk erfoagreining ehf. to data from medical files in the custody
of the [Health Institution], the procedural arrangements for the processing of
such data for transfer to the Health Sector Database, and their subsequent
transfer to the Health Sector Database; The [Health Institution] and Islensk
erfoagreining ehf. hereby enter into the following
Contract:
<PAGE> 3
1. Definitions
1.1. All terms defined in Section 2.1. of the Operating Licence of
Islensk erfoagreining shall have the same meaning herein, wherever
they appear.
2. Categories of clinical data to be processed and prepared for transfer to
the Health Sector Database pursuant to this Contract
2.1. [HI] will, during the Contract Period, prepare for transfer and
subsequently transfer to the Health Sector Database the clinical
data specified in Annex 1 hereto and determined pursuant to Section
3.3. hereof.
2.2. Islensk erfoagreining may, during the Contract Period, request that
[HI] process and prepare for transfer to the Health Sector Database
all the clinical data specified at any time in Annex B to the
Operating Licence of Islensk erfoagreining, regardless of whether
they are specified in Annex 1 hereto.
2.3. Annex 1A to this Contract specifies clinical data which, in addition
to the clinical data specified in Annex B to the Operating Licence
of Islensk erfoagreining, shall be recorded in an electronic
clinical records file pursuant to the General Specifications for
Clinical Records Systems in Annex A to the Islensk erfoagreining
Operating Licence ("Supplementary Clinical Data"). [HI] agrees, for
its part, to process and prepare for transfer to the Health Sector
Database the Supplementary Clinical Data pursuant to Annex 1A at the
request of Islensk erfoagreining, provided that approval has been
obtained from the Data Protection Commission and the Monitoring
Committee.
2.4. Islensk erfoagreining may, during the Contract Period, request that
[HI] process and prepare for transfer to the Health Sector Database
other data than those specified in Annex B to the Operating Licence
of Islensk erfoagreining and Annex 1A hereto. In addition to the
approval of [HI], the transfer of such data to the Health Sector
Database shall, as applicable, be subject to the approval of the
Data Protection Commission and the Monitoring Committee.
3. Assessment of Classification and Volume of Clinical Data, Condition and
Integrity
3.1. [HI] shall immediately on the effect of this Contract perform an
assessment of the clinical data recorded by [HI] or in the custody
of [HI]. The assessment shall be in the form attached hereto in
Annex 2. The assessment shall specify the clinical data available
and recorded, their condition, the form in which they are recorded
and whether any clinical data require special processing in order to
prepare them and subsequently transfer them to the Health Sector
Database. As regards the cost of the assessment, reference is made
to Section 12.2 hereof.
The assessment shall also specify the clinical data recorded and
processed by [HI] on the effective date of this Contract, the
methods of recording and processing and the form in which the
clinical data are recorded. Furthermore, the assessment shall
outline any future plans of [HI] for new/altered recording of
clinical data. An attempt shall be made to conclude [HI]'s
assessment pursuant to this Section no later than two months
following the date of signature of this Contract.
3.2. The Contracting Parties shall co-operate on the assessment of the
quality and integrity of the clinical data of [HI], the cost and
benefits of processing, taking into account the condition and
usefulness of clinical data in connection
<PAGE> 4
with this Contract. Should the parties see reason to do so, they may
each appoint one party to work on the above projects.
3.3. Following the assessment and evaluation by the parties pursuant to
the above, Islensk erfoagreining shall decide what clinical data
[HI] pursuant to Annex 1 hereto shall be processed and prepared for
transfer and subsequently transferred to the Health Sector Database
pursuant to this Contract. As regards the stages of processing
clinical data, reference is made to Article 5 hereof.
4. Organisation of the processing of clinical data for transfer to the Health
Sector Database
4.1. Processing of clinical data pursuant to this Contract shall take
place on the premises of [HI] and in such places as activities of
[HI] are conducted.
4.2. [HI] is responsible for the observation of legislation and
regulations in the processing of clinical data for transfer to the
Health Sector Database.
4.3. [HI] guarantees that all processing of clinical data for transfer to
the Health Sector Database will be performed, or its performance
managed, by qualified health-care personnel of the [HI].
4.4. [HI] shall provide Islensk erfoagreining with information on which
employees of [HI] are directly involved in transferring clinical
data to the Health Sector Database. Islensk erfoagreining shall
ensure that such employees are not involved in the operation of the
Health Sector Database.
4.5. [HI] and Islensk erfoagreining will jointly organise regular courses
and training for the employees of [HI] on the processing of data for
transfer to the Health Sector Database in order to ensure the
quality and integrity of clinical data.
4.6. In the event that it proves necessary to label and amend clinical
data, [HI] will perform this work in consultation with Islensk
erfoagreining and in accordance with the rules and procedures
specified in Annex 3 hereto.
4.7. The arrangements and implementation of the processing of clinical
data and their preparation for transfer to the Health Sector
Database are divided into four stages, as further specified in
Article 5 hereof.
5. Stages in the Processing of Clinical Data and their Transfer to a Health
Sector Database
5.1. Stage 1: older clinical data in machine-readable form
5.1.1. The first stage covers clinical data in machine-readable
form, recorded and preserved by the [HI] on the effective date
of this Contract.
5.1.2. [HI] undertakes to process and prepare for transfer to the
Health Sector Database, pursuant to Stage 1, the classes of
clinical data specified in Annex 1 hereto, subject, however,
to Section 3.3. The intention is to process clinical data
dating back to 1986, cf. Section 4.6 in the Operating Licence
of Islensk erfoagreining, with due consideration to usefulness
and cost.
5.2. Stage 2: clinical data recorded on documents and paper
5.2.1. Stage 2 covers clinical data recorded on documents and paper.
5.2.2. [HI] undertakes to process clinical data available on paper
and documents in [HI] and prepare them for transfer to the
Health Sector
<PAGE> 5
Database. Classes of clinical data to be processed for
transfer to the Health Sector Database in stage 2 are
specified in Annex 1 hereto, subject, however to Section 3.3.
5.3. Stage 3: Processing of clinical data using medical filing systems
used by [HI] in its activities on the effective date of this
Contract.
5.3.1. Stage 3 covers processing of clinical data using medical
filing systems used by [HI] in its activities on the effective
date of this Contract.
5.3.2. [HI] and Islensk erfoagreining shall in joint consultation
conduct an assessment of the medical filing systems used by
[HI] in its recording and processing of clinical data.
5.3.3. The assessment shall cover all the principal disadvantages of
the current medical filing systems and the impact they have or
may have on the processing of the clinical data subject to
processing under this Contract. The parties may decide to make
temporary improvements in the current medical file systems, if
both agree that this is necessary, in order to make it
possible to process clinical data under Stage 3.
5.3.4. [HI] undertakes to process and prepare for transfer to the
Health Sector Database, pursuant to Stage 3, the classes of
clinical data specified in Annex 1 hereto, subject, however,
to Section 3.3.
5.4. Stage 4: Processing of clinical data using the Integrated Health
Institution Clinical Records System
5.4.1. An agreement has been reached to the effect that [HI] will
take into use an Integrated Clinical Records System, as
further detailed in Article 8 hereof. After [HI] has taken
such a clinical records system into use, [HI] clinical data
will recorded and processed based on the structure of the
electronic Clinical Records Systems based on the general
specifications of the Ministry of Health and Social Security.
Coded and other numerical data defined in Annex B to the
Operating Licence of Islensk erfoagreining, "Transfer of Data
to the to the Health Sector Database", shall be transferred
from the electronic clinical records systems to the Health
Sector Database through the Encryption Agency of the Data
Protection Commission.
5.5. Transfer of Clinical Data from Independent Systems
5.5.1. On the date of effect of this Contract, or at any time during
its term of effect, there may be in existence at [HI]
independent systems created for scientific research and other
activities not directly related to patient services and/or
independent systems set up for experimental or development
purposes. Should Islensk erfoagreining request that [HI]
transfer clinical data from such systems to the Health Sector
Database, [HI] will accede to such request, assuming there are
no reasonable grounds for refusal in specific cases, provided
that an agreement has been reached between Islensk
erfoagreining and the originators and owners of such systems,
to the extent that such originators and owners are not [HI]
itself, and provided also that approval has been obtained from
the Data Protection Commission and the Monitoring Committee,
<PAGE> 6
as applicable. Work on preparations for such transfer shall
then be integrated into project stages pursuant to the above,
as applicable.
6. Start of Processing of Clinical Data at [HI] for Transfer to the Health
Sector Database Pursuant to this Contract
6.1. It is the understanding of the parties that processing of clinical
data pursuant to Stage 1 will begin following assessment of clinical
data pursuant to Article 3 and following a decision pursuant to
Section 3.3.
6.2. It is understood that processing of clinical data pursuant to Stage
2 will begin following assessment of clinical data pursuant to
Article 3 and following a decision pursuant to Section 3.3.
6.3. It is understood that processing of clinical data pursuant to Stage
3 will begin when approval has been obtained for the transfer of
clinical data processed under this Contract to the Health Sector
Database and that such processing will continue until processing
pursuant to Stage 4 begins.
6.4. It is understood that processing of clinical data and their transfer
to the Health Sector Database pursuant to Stage 4 will begin when
[HI] takes into use a clinical records system meeting the general
specifications of the Ministry of Health and Social Security for
clinical records systems.
7. Arrangements for the transfer of clinical data to the Health Sector
Database
7.1. Preparations for the transfer of clinical data to the Health Sector
Database will take place under the management and on the
responsibility of [HI] pursuant to the provisions hereof. Personal
identifiers will be encrypted one way at [HI]. Clinical data shall
be transferred in encrypted form to the Data Protection Commission
Encryption Agency.
7.2. [HI] will perform and take responsibility for the transfer of
clinical data pursuant to this Contract from the [HI] to the Data
Protection Commission Encryption Agency. [HI] shall observe the
terms of the Data Protection Commission.
7.3. Islensk erfoagreining will supply software and hardware for the
encryption and transfer of clinical data from [HI] to the Data
Protection Commission Encryption Agency.
7.4. The frequency and details of the transfer of clinical data processed
for transferring and subsequent transfer to the Health Sector
Database to the Data Protection Commission Encryption Agency shall
be subject to further agreement between the parties.
8. Integrated Clinical Records System
8.1. Pursuant to the provisions of the Operating Licence of the company
and the further provisions of this Article 8, Islensk erfoagreining
will co-operate with [HI] on installing at [HI] a clinical records
system conforming to the General Specifications for Clinical Records
Systems of the Ministry of Health and Social Security, as current at
any time, and other conditions of the Operating Licence, as well as
the special requirements of Islensk erfoagreining regarding the
recording and processing of clinical data for transfer and their
subsequent transfer to the Health Sector Database. With the
integrated clinical records system, the recording and processing of
clinical data at [HI] will be standardised in all the data recording
systems used by the [HI] at any
<PAGE> 7
time to record clinical data in its activities. "Data recording
systems" refers to computer software used by health sector personnel
to record clinical data in the course of their work. An integrated
clinical records system consists of data recording systems,
communications systems capable of retrieving and providing access to
clinical data from individual data recording systems, and a user
interface that displays clinical data provided by the communications
system. The integrated clinical records systems shall be capable of
sending and receiving clinical data over the Icelandic Health
Network currently in preparation by the Health Authorities.
8.2. In the course of the installation of the integrated clinical records
system at [HI] it will be determined to what extent it is possible,
and feasible, for both contracting parties to continue to use the
data recording systems being used by [HI] for the recording of
clinical data on the effective date of this Contract. The parties
shall jointly conduct an assessment of the data recording systems in
question and the contracts concluded with their proprietors.
8.3. Following the joint assessment pursuant to Section 8.2, and, as
applicable, following negotiations with the proprietors of the
systems in question, the parties shall make a decision on what data
recording systems will continue in use as part of the integrated
clinical records system of [HI], and what data recording systems
will be discontinued. In arriving at decisions in this respect,
account shall be taken of the experience of [HI] of the data
recording systems in question, the future prospects of the systems
in the light of other available options, their usefulness in
processing clinical data for the Health Sector Database, and the
reasonable interests of Islensk erfoagreining in achieving
co-ordination and minimising the costs of the methods and solutions
of taking into use the integrated clinical records systems selected
by individual health institutions and self-employed health service
workers with whom Islensk erfoagreining contracts for the processing
of clinical data for transfer to the Health Sector Database and
their subsequent transfer.
8.4. In the event of a decision, following assessment pursuant to Section
8.2, to discontinue the user of a data recording system in use at
[HI], or if there is a need to add a new data recording system,
Islensk erfoagreining shall, in consultation with [HI] and with due
consideration to the special needs of both parties, create, have
created, or purchase such a data recording system and supply it to
[HI]. Islensk erfoagreining shall, in the same way, create, have
created or purchase and supply to [HI] communications systems and
user interfaces for the integrated clinical records system.
8.5. [HI] shall be a formal contracting party vis-a-vis the owners of the
proprietary rights to the data recording systems to be used pursuant
to this Contract in the recording and processing of clinical data,
and vis-a-vis the owners of communications systems and user
interfaces for the integrated clinical records system. All such
contracts and amendments to them shall be subject to the consent of
Islensk erfoagreining. Payments of licence fees shall be subject to
Section 12.1.
8.6. After the integrated clinical records system has been taken into use
at [HI], the participation of Islensk erfoagreining in the cost of
the renewal of data
<PAGE> 8
recording systems, communications systems and user interface, and
the installation of additional systems shall be subject to the prior
approval of Islensk erfoagreining. The same applies to costs of
updating or increasing the capacity of data recording systems,
communications systems or user interface for the integrated clinical
records system. The creation of new systems shall be subject to the
provisions of Section 8.4.
8.7. In the event that a data recording system, communications system or
user interface used by [HI] as part of the integrated clinical
records system has become inefficient, e.g. for technical,
professional or financial reasons, Islensk erfoagreining and [HI]
shall jointly decide whether a request should be made to the owner
of the proprietary rights to the system for amendments to the
contract or whether the contract should be terminated. Both Islensk
erfoagreining and [HI] may take the initiative as regards the review
of a contract with the owner of the proprietary rights to such
system pursuant to the above.
9. Development Projects
9.1. Islensk erfoagreining and [HI] will explore the potential for
co-operation during the term of this contract as regards development
projects relating to the creation and utilisation of clinical
records systems or other related projects. The parties shall enter
into separate contracts on each such project.
10. The Share of Islensk Erfoagreining in Payments to [HI] in Respect of
Third-Party Access Granted by [HI] to the Clinical Records System
10.1. In the event that [HI] or employees of [HI], alone or in
co-operation with other parties, use the clinical records system set
up at [HI] pursuant to Article 8 for research, and [HI] receives
payments from a third party in respect of the research, Islensk
erfoagreining shall be entitled to a share of such third-party
payments or their value (e.g. if payments take the form of
instruments or other equipment) following deduction of direct costs
of [HI] of the research in question. The share of Islensk
erfoagreining shall be 35%, unless the parties hereto agree
otherwise in individual cases. [HI] shall immediately inform Islensk
erfoagreining of any events giving rise to payments to [HI] pursuant
to the above. Payment of shares to Islensk erfoagreining shall be
made within 10 days of receipt by [HI] of individual third-party
payments. Islensk erfoagreining shall be entitled to have a
chartered accountant appointed by Islensk erfoagreining verify that
payments to Islensk erfoagreining in compliance with the above
provisions. The accountant shall be entitled, for this purpose, to
examine the payment clauses of contracts made by [HI] with third
parties regarding the above, as well as accounting documents and
other documents of [HI] as necessary at his discretion.
11. Confidentiality
11.1. The contracting parties and their employees shall keep in confidence
everything of which they may become aware in the course of their
work regarding the activities of each other. The confidentiality
shall remain in effect following the end of the Contract.
11.2. The contracting parties declare that they and their employees will
treat information regarding this contract and its implementation as
confidential,
<PAGE> 9
subject to the obligation of [HI] to provide information under the
Information Act.
12. Payments of Islensk Erfoagreining for Processing of Clinical Data Pursuant
to this Contract
12.1. Islensk erfoagreining will pay the cost of creating an integrated
clinical records system, cf. Article 8, and new version thereof, and
[HI] will refund license fees in respect of licence contracts with
the owners of the proprietary rights.
12.2. Islensk erfoagreining will pay the cost of assessment pursuant to
Article 3, including wage costs and other costs of [HI].
12.3. Islensk erfoagreining will pay the wage costs and operating costs of
[HI] resulting from the processing of clinical data for transfer to
the Health Sector Database. This cost shall be specified in a
separate cost and time schedule prepared jointly by the parties
hereto when the assessment pursuant to Article 3 has been carried
out and the decision of Islensk erfoagreining pursuant to Section
3.3 on the processing of clinical data for transfer to the Health
Sector Database has been made. The schedule shall describe the
project stages and set out the project schedule, and estimate the
human resources required and other costs for each stage, cf. Article
5. The schedule shall furthermore estimate the cost of teaching and
training health care employees in the recording and processing of
clinical data. In the event of part-time employment of an [HI]
employee, who is also engaged in other work, the proportion of work
shall be determined in the preparation of the cost estimate. [HI]
guarantees that the project schedule will be observed. The cost and
time schedule shall be subjected to review once every six months.
Islensk erfoagreining may suspend payment for work which is
demonstrably not performed pursuant to the schedule, provide that
there is no reasonable justification for such deviation. [HI] may
halt the transfer of clinical data pursuant to this Contract to the
Encryption Agency if Islensk erfoagreining does not effect payments
pursuant to this contract.
12.4. Islensk erfoagreining will supply [HI] with and pay [HI]'s costs of
special hardware and/or software necessary to enable processing of
clinical data for transfer to the Health Sector Database pursuant to
stages 1 and 2. Islensk erfoagreining will also pay the cost of
software and hardware for the encryption and transfer of clinical
data from [HI] to the Data Protection Commission Encryption Agency
which Islensk erfoagreining supplies to [HI] pursuant to Section
7.3. Furthermore, Islensk erfoagreining will pay all
telecommunications cost relating to the transfer of clinical data
from [HI] to the Data Protection Commission Encryption Agency.
12.5. [HI] and the employees of [HI] may, at no separate cost, submit
queries to the Health Sector Database for their own research
conducted by themselves. Such queries shall be subject to normal
rules on queries to the Health Sector Database. The above permission
of [HI] and [HI] employees does not extend to queries made for third
parties or in respect of scientific research or other projects
conducted in co-operation with third parties which pay [HI] or [HI]
employees for their roles in the research. Such queries and payments
for them
<PAGE> 10
to Islensk erfoagreining shall be treated as third-party queries to
the Health Sector Database. Islensk erfoagreining shall be entitled
to receive from [HI] or the employees of [HI] who submit queries to
the Health Sector Database based on the above provision satisfactory
information on the nature of and the parties responsible for the
scientific research in question in order to clarify whether the
query falls under the said provision. Islensk erfoagreining may
refuse a request of [HI] or employees of [HI] for processing of a
query without special payment if Islensk erfoagreining has
reasonable grounds for believing that the provisions of this Article
are being violated.
13. Term of Effect of the Contract
13.1. This contract shall take effect on its confirmation by the
Monitoring Committee, cf. Article 19, as of its date of signature.
The Contract shall remain in effect while Islensk erfoagreining is
in possession of an operating licence pursuant to law for the
creation and operation of a Health Sector Database.
13.2. If [HI] is merged with another health institution, or its activities
or scope of activities are changed, with the result that the basis
for this Contract is altered, Islensk erfoagreining may request a
review of its terms.
13.3. In entering into this Contract, the parties recognise that it is
impractical to make provisions for every contingency which may arise
during the effective term of the Contract. The parties declare it to
be their intention that the Contract shall be operated between them
with fairness.
13.4. Should however the occurrence of events, including fundamental
changes in the arrangement or implementation of health services at
[HI], or in the basis for operation of the Health Sector Database,
beyond the control of the parties, and not reasonably foreseeable by
the parties on entering into this Contract, and if such events have
the effect that the premises of either party for entering into the
Contract are fundamentally altered with the result that the
unchanged operation of the Contract would cause unfairness to that
party, the parties will meet and in good faith negotiate and use
their best endeavours to agree upon an amendment to this agreement
to counteract such unfairness. In the event that the parties are
unable to agree as to the existence of such unfairness or reactions
to such unfairness, either party may refer the dispute to
arbitration pursuant to Article 17 hereof. Notwithstanding the
foregoing, neither party may invoke the provisions of this Section
13.4 prior to 22 January 2006, or more than one time during the term
of the original Operating Licence of Islensk erfoagreining, or more
than one time during the term of an extended or new Operating
Licence for Islensk erfoagreining.
14. End of the contract
14.1. At the end of this Contract, [HI] is entitled, against reasonable
remuneration, to a licence to software owned by Islensk
erfoagreining and custom made for [HI] for the recording and
processing of clinical data. The licence shall cover the right to
further development of such software for use in the activities of
[HI]. All such additions and improvements shall be delivered to
Islensk erfoagreining as they come into existence. Islensk
erfoagreining will be the
<PAGE> 11
owner of all such additions and improvements with unlimited rights
of utilisation and disposal.
15. Contracting
15.1. The contracting parties may contract with other parties to perform
work on their behalf on individual components of this Contract with
the prior approval of the Monitoring Committee and/or the Data
Protection Commission, where the component in question requires the
consent of those parties. If the parties employ another party to
perform its contractual obligations hereunder, they shall guarantee
the work of such party to the other party pursuant to the provisions
hereof.
16. Operation of the Contract
16.1. [HI] and Islensk erfoagreining shall hold regular progress meetings
on the operation of this Contract. A record of minutes shall be kept
of proceedings of meetings and the parties shall have equal access
to the minutes.
17. Settlement of Disputes
17.1. In the event of any dispute regarding the interpretation of this
Contract, and if no agreement can be reached between the parties on
the issue in dispute, an arbitration tribunal composed of three
arbitrators, one nominated by each party and a third nominated by
the District Court of Reykjavik, shall resolve the dispute. In other
respects, the arbitration and arbitration proceedings shall be
governed by Act No. 53/1989 on Contractual Arbitration.
17.2. Notwithstanding the provisions of Section 17.1, a contracting party
who believes that a quick settlement is needed may submit the
dispute to an arbitrator agreed by both contracting parties on the
signature of this Contract or subsequently selected as his
replacement. The arbitrator shall submit an interim decision
regarding the dispute within 7 days of the submission of the
dispute. The decision shall be based only on documents submitted
before the said deadline and before the arbitrator accepts the
dispute for decision. The arbitrator shall decide which party shall
bear the cost of his work and the amount of the cost. In other
respects, the work of the arbitrator and rules of procedure shall be
governed by Act No. 53/1989 on Contractual Arbitration. The decision
of the arbitrator can be submitted to arbitration pursuant to
Section 17.1, provided that this is done within 14 days from the
delivery of his decision.
<PAGE> 12
18. Miscellaneous Provisions
18.1. [HI] shall take regular backup copies of clinical data recorded in
its data recording systems. The frequency and arrangements of such
backing up shall be in accordance with accepted practice.
19. Approval of the Monitoring Committee
19.1. This Contract is concluded subject to the approval of the Monitoring
Committee.
[Place of signature], [Date]
For the [Health Institution] For Islensk erfoagreining ehf.
------------------------------ ------------------------------
Kari Stefansson, CEO.