October
18, 2004
PROCEDURES
for the
DICOM Standards Committee
1
Scope of the DICOM Standards Committee
Numerous
and diverse medical specialties create biomedical images. The DICOM Standards Committee exists to
create and maintain international standards for the communication of
biomedical, diagnostic and therapeutic information in those medical disciplines
that use digital images and associated data.
The
goal of the DICOM Standard is to achieve compatibility and improve workflow
efficiency between imaging systems and other information systems in healthcare
environments worldwide.
DICOM
is a cooperative standard. Connectivity
works because vendors cooperate in testing via scheduled public demonstrations,
over the Internet, and during private test sessions. Every major diagnostic medical-imaging vendor in the world has
incorporated the standard into its product design, and most are actively
participating in the enhancement of the standard. Most biomedical professional societies throughout the world support
and participate in the enhancement of this standard.
Proposed
standards are developed by working groups reporting to the Committee and are
approved by the members of the Committee.
Standards are published by the secretariat and are international in
scope. The Committee is proactive to
assure compatibility with related standards developed by other
standards-developing and coordinating bodies such as ANSI, CEN, HL7, IEC, ISO
and JIRA.
2
Membership
The
Committee consists of its members and the secretariat. Membership in the Committee consists of
manufacturing companies, service organizations, consulting companies,
biomedical professional organizations, trade associations, other
standards-developing organizations and government agencies worldwide that have
a direct and material interest in the activities of the Committee.
The
addition or termination of members shall be subject to approval by vote of the
Committee as provided in this section.
2.1
Responsibility of Committee Members
The
Committee members are responsible for:
a)
Developing proposed standards within the scope of the
Committee;
b)
Voting to approve proposed standards within its scope;
c)
Maintaining the Committee’s standard by reaffirming,
revising or withdrawing the standard within five years of its approval;
d)
Responding to requests for interpretations of the
Committee’s standard;
e)
Adopting Committee policy and procedures and revisions
thereof;
f)
Considering and acting on proposals for termination of the
Committee and
g)
Other matters requiring Committee action as provided in
these procedures.
2.2
Application
A
request for membership shall be addressed to the secretariat and shall indicate
the:
a)
Applicant’s direct and material interest in the Committee’s
work;
b)
Applicant’s qualifications and willingness to participate
actively;
c)
Interest category of the applicant and
d)
Identification of a principal representative (and
alternate(s), if desired).
2.2.1
Recommendation
The
secretariat shall make a recommendation to the Committee for action on
applications for membership it receives.
In recommending appropriate action to the Committee, the secretariat
shall consider the:
a)
Need for active participation by each interest;
b)
Potential for dominance by a single interest category;
c)
Extent of interest expressed by the applicant and the
applicant’s willingness to participate actively and
d)
The representative identified by the applicant
organization, company, or government agency.
The
secretariat may consider reasonable limits on Committee size.
2.2.2
Diverse Interests
If
distinct divisions of an organization can demonstrate independent interests and
authority to make independent decisions in the area of the activity of the
Committee, each may apply for membership.
2.2.3
Combined Interest
When
appropriate, the secretariat may recommend that the applicant seek
representation through an organization that is already a member and represents
the same or similar interest.
2.2.4 Review of Membership
The
secretariat shall review the membership with respect to the criteria of this
section. Members are expected to
fulfill obligations of active participation and maintaining current
payment of dues.
If
any member of the Committee is not represented at two consecutive meetings of
the Committee, the member will not be counted in the determination of a quorum
for the next meeting at which it is not represented. After the second meeting where the member is not represented, the
secretariat shall notify the member in writing. The member’s representative may vote at the next meeting that he
or she does attend.
Members
shall be suspended from the Committee if they do not pay their dues within
three months of the invoice date.
Suspended members have no voting rights in committee meetings or letter
ballots. Suspended members will be
reinstated if dues are received within six months of the invoice date.
Members
shall be terminated from the Committee if they do not pay their dues within six
months of the invoice date. Terminated
members may be reinstated only by vote of the Committee.
2.2.5
Observers
Individuals
and organizations having an interest in the Committee’s work may request
listing in the Committee’s roster as observers (mailers).
Observers
shall be advised of the Committee activities, may attend meetings and may
submit comments for consideration, but they shall have no vote.
2.2.6
Interest Categories
All
appropriate interests that might be directly and materially affected by the
standards activity of the Committee shall have the opportunity for fair and
equitable participation without dominance by any single interest. Each member shall propose its own interest
category as appropriate and in accordance with the Committee's established
categories.
Members
are classified into the following interest categories: producers, users, and
general interest.
The
interest categories may be revised by a vote of the Committee upon
recommendation of the secretariat. The
rationale for the selection of categories shall be included in the Committee
ballot.
2.3
Member Affiliation
2.3.1
Producers
Any
manufacturing company, service organization or consulting company that wishes
to participate in standards development within the scope of the Committee may
apply for membership on the Committee.
Each
company or service organization elected to membership shall designate one
principal voting representative to represent it on the Committee. One or more alternate representatives may
also be designated.
Each
member company or service organization shall have a single vote in the business
of the Committee.
Manufacturing
companies, service organizations and consulting companies elected to membership
shall be classified as producer members.
2.3.2
Biomedical Professional Organizations
Any
biomedical professional organization that wishes to participate in standards
development within the scope of the Committee may apply for membership on the
Committee.
Each
biomedical professional organization elected to membership shall designate one
or more voting representatives to represent it on the Committee, providing that
representatives from any single organization do not compose more than 20% of
the total membership in the Committee.
Each
person who represents a biomedical professional organization shall have one
vote in the business of the Committee.
Biomedical
professional organizations elected to membership shall be classified as user
members.
2.3.3
Trade Associations
Any
trade association that is not, also, a standards-developing organization and
wishes to participate in standards development within the scope of the
Committee may apply for membership on the Committee.
Each
member association shall designate a principal voting member to represent it on
the Committee. One or more alternate
representatives may also be designated.
Each
member association shall have one vote in the business of the Committee.
Trade
associations elected to membership shall be classified as producer members.
2.3.4
Standards-Developing Organizations
Any
standards-developing organization that wishes to participate in standards
development within the scope of the Committee may apply for membership on the
Committee.
Each
standards-developing organization elected to membership shall designate one
principal voting representative to represent it on the Committee. One or more alternate members may also be
designated.
Each
standards-developing organization elected to membership on the Committee shall
have one vote in the business of the Committee.
Standards-developing
organizations elected to membership may be classified either as producers or as
general interest members.
2.3.5
Government Agencies
Any
government agency that wishes to participate in standards development within
the scope of the Committee may apply for membership on the Committee.
Each
government agency elected to membership on the Committee shall designate one
voting representative to represent it on the Committee. One or more alternate members may also be
designated.
Each
government agency elected to membership on the Committee shall have one vote in
the business of the Committee.
Government
agencies elected to membership shall be classified as either users or general
interest members.
2.4
Dues
Dues
are determined annually based on an annual budget and operating plan. Dues are collected and administered by the
secretariat. Dues are based on the
categories of membership.
3
Committee Structure
3.1
Officers
There
shall be two co-chairs – one representing a producer and one representing a
biomedical professional organization.
Each
co-chair shall serve a two-year term and may serve no more than two consecutive
terms. The terms of the co-chairs shall
expire in alternate years.
At
the meeting preceding the meeting before the last Committee meeting each year,
the co-chairs shall appoint a three-member nominating subcommittee consisting
of at least one representative of a producer, one representative of a
biomedical professional organization and one former committee officer (if one
is available). The former officer (if
one is available) shall chair the nominating subcommittee. Members of the nominating subcommittee shall
develop and submit to the secretariat a slate of candidates. The names of the candidates should be
submitted to the secretariat no later than 30 days prior to the meeting
preceding the last meeting of the year so that their names may be included in
the published agenda. Additional
nominations may be made from the floor at this meeting.
Prior
to the last meeting of the year the secretariat shall conduct a letter
ballot. The name of the person elected
shall be announced at the last meeting of the year. That person shall assume office immediately following the last
meeting of the year.
One
co-chair shall be designated as the presiding officer for each portion of
Committee meetings.
The
Committee has the right to recall a co-chair.
There
shall be a secretary who is appointed by the secretariat.
3.2
Executive Committee
The
Committee may elect an Executive Committee.
If
one is created, the membership shall consist of:
a)
The officers of the Committee;
b)
The chair of the Base Standard Working Group;
c)
The principal individual representing NEMA on the
Committee;
d)
A minimum of one and a maximum of three members at large
(chosen from among the members of the committee) and
e)
The two most recent past chairs of the Committee (one
producer and one user), if they are available to serve.
The
responsibilities of the Executive Committee are to:
a)
Provide advice on, and resolution of, administrative issues
as requested by the secretariat;
b)
Develop recommendations to the Committee (e.g., agenda for
Committee meetings, changes in the Committee procedures and recall of an
officer) and
c)
Fulfill other responsibilities specifically delegated by
the Committee.
4
Subgroups
4.1
Function
The
Committee may form subgroups (often called working groups) to expedite the work
of the Committee. Their formation (and
later disbandment) requires approval by a majority vote of the Committee and
appropriate notice to those who have interest in the activities of the
Committee.
The
scope and duties delegated to the subgroup shall be approved at the time it is
formed. Subsequent changes in scope or
duties shall also require Committee approval.
All
subgroups shall:
a)
Be project oriented with clear deliverables or have other,
well-defined responsibilities;
b)
Have appropriate membership from interest categories
represented on the Committee and
c)
Have a subgroup secretariat and a secretary (as provided in
Section 5.2, below) who will work closely with the Committee’s secretariat to
assure proper conduct and documentation of subgroup activities.
The
charge to the subgroup shall clearly state whether the subgroup is responsible
for:
a)
The definitive content of one or more proposed standards
(or parts of a standard) and for responding to views and objections thereon; or
b)
Assisting the Committee in some other way.
Subgroups
responsible for the definitive content of a proposed standard shall:
a)
Maintain a membership roster in accordance with 5.1(c);
b)
Maintain fair and equitable participation in accordance
with Section 2.3, except the 20% rule in Section 2.3.2;
c)
Conduct open meetings in accordance with Section 6; and
d)
Operate in accordance with Section 7 as applied to voting
on proposed standards.
The
Committee shall annually review the scope, duties and membership of all
subgroups.
4.2
Members and Officers of Subgroups
There
are two ways that a company, organization or agency may become a member of a
subgroup:
a)
A member of the Committee may join a subgroup by informing
the Committee’s secretariat of its desire to participate in the work of the
chosen subgroup and designating the name and contact information for its voting
representative and, if desired, one or more alternates;
b)
The officers of a subgroup may nominate one or more
companies, organizations, agencies or individuals for participation on that
subgroup. Such a nomination shall be
submitted to the Committee and shall include evidence that the proposed member
meets the criteria spelled out in Sections 2.2, above. Such nominations shall be accompanied by
information regarding the proposed member’s voting representative and
alternate(s), if any. The Committee
shall vote on such nominations and appoint those companies, organizations,
agencies or individuals that are approved.
Each
subgroup shall elect a chair or co-chairs.
Other officers may be elected by the subgroup.
If
any member of a subgroup is not represented at two, consecutive, fact-to-face
meetings of the subgroup, that member shall be suspended from the
subgroup. Suspended members:
a)
Will not be counted in determining a quorum for
face-to-face meetings and telephone conferences;
b)
May vote in telephone conferences, but participation in the
conference call will not affect the member's suspension status and
c)
Will be reinstated to good standing in the subgroup if they
attend one of the next two face-to-face meetings.
If a
subgroup member is not represented at four consecutive face-to-face meetings,
then, it shall be converted to observer (mailer) status in that subgroup. The company, organization or agency may be
reinstated as a member if it is represented at a face-to-face meeting and
submits a written request for reinstatement to the subgroup’s secretary.
4.3
Observers
Individuals
and organizations having an interest in the work of a subgroup may request
listing in the subgroup’s roster as observers (mailers).
Observers
shall be advised of the subgroup’s activities, may attend meetings and may
submit comments for consideration, but they shall have no vote.
4.4
Base Standard Working Group
The
Committee shall form a subgroup with responsibility for assuring technical
consistency and maintaining the overall structure of DICOM standards. This subgroup shall be called the Base
Standard Working Group.
The
responsibilities of this working group are described in Section 8, below.
This
working group may also perform other functions, such as the development of
proposed standards.
5
Secretariat
5.1
Secretariat of the Committee
The
National Electrical Manufacturers Association (NEMA) is secretariat of the
Committee.
Meetings
of the Committee shall operate under these procedures and the secretariat's
appeal procedures. The secretariat
shall:
a)
Organize the committee.
b)
Oversee the Committee’s compliance with these and the
secretariat's procedures.
c)
Maintain a current and accurate roster of the Committee and
distribute it to the members at least annually and, otherwise, on request. The roster shall include the following:
·
Title of the Committee;
·
Scope of the Committee;
·
Name and address of the secretariat and secretary;
·
Officers;
·
Members -- including the name of the organization, company
or agency; its voting representative and alternate(s) with their addresses and
other contact information;
·
Classification of each member;
·
Tally of classifications: total of voting members and
subtotals for each interest category and
·
Subgroups: title, chair, and names and addresses of all
members.
d)
Maintain a list of standards for which the Committee is
responsible;
e)
Provide a Committee secretary to perform administrative
work including:
·
Handling meeting arrangements;
·
Distributing meeting notices, agendas, minutes, ballots and
draft standards and
·
Maintaining adequate records;
f)
Collect Committee dues and provide accounting support;
g)
Arrange for the publication of Committee standards,
revisions, and addenda;
h)
Maintain a list of ongoing standardization projects and
their status and
i)
Perform other administrative functions as required.
5.2
Secretariat of Subgroups
For
the DICOM Standards Committee, Working Group Six (Base Standard) and Working
Group Ten (Strategy), the full-time attendance of a member of the secretariat's
staff is required at every meeting to provide secretarial services.
For
other subgroups, the Committee may designate another organization to perform
the duties of the secretariat. Such
subgroup secretariats shall be approved by the Committee secretariat. Meetings of all subgroups served by
secretariats other than NEMA shall operate under these Committee procedures and
the procedures of the subgroup’s secretariat.
The subgroup secretariat shall:
a)
Oversee the subgroup's compliance with these and the
subgroup secretariat's procedures;
b)
Maintain a roster of the subgroup;
c)
Provide a secretary to perform administrative work
including:
·
Handling meeting arrangements;
·
Distributing meeting notices, agendas, minutes, ballots and
draft standards and
·
Maintaining adequate records;
d)
Forward copies of the meeting minutes to the DICOM
secretariat for legal review and for posting to the Committee’s web page;
e)
Perform other administrative functions as required and
f)
Follow the meeting procedures as provided in Section 6.
Additionally,
as a means of conserving resources, the Committee secretariat may request a
member (which is not a producer) to allow its representative to perform some of
the duties of the secretariat for a specific subgroup – e.g., to host a meeting
or to prepare minutes of a meeting and, subsequently, assure that they are
delivered directly to the secretariat for the working group. That person shall insure that the
discussions at the meeting do not violate NEMA’s antitrust rules as listed in
Section 6.1.
6
Meetings
Committee
meetings shall be held to conduct business, such as making assignments,
receiving reports of work, considering proposed standards, resolving
differences among subgroups, and considering views and objections from any
source.
The
frequency of Committee meetings shall be determined by the Committee. Additional meetings may be called by an
officer, the secretariat, or by petition to the secretariat of five or more
members.
Meetings
of subgroups may be held as decided upon by the members or the chair of the
subgroup.
Meetings
of the Committee and subgroups shall be open to all individuals having a direct
and material interest.
6.1 Meeting Conduct for Vendor Members
All
meetings of the Committee and subgroups shall be conducted under the following
procedures and any additional procedures that the secretariat may prescribe to
avoid any antitrust problems.
a)
No commercial topics shall be acted upon or even
considered. To avoid the most sensitive
areas, there shall never be a discussion of the following at Committee or
subgroup meetings:
·
Current or future prices or components thereof, including
discounts, rebates, and credit terms;
·
Price list or procedures for coordinating price changes;
·
Sales or production quotas;
·
Allocation or division of territories of customers among
manufacturers, distributors, or retailers;
·
Boycotting any party or denying any party access to
markets, products, product inputs, or information;
·
Identified individual company statistics, market shares,
inventories or merchandising methods;
·
Commercial practices, warranties, guarantees, or the
particular terms and conditions of sales, including credit, shipping and
transportation arrangements, or
·
Anything dealing with "arm-twisting," trade
abuses, or excluding or controlling competition.
b)
Committee and subgroup meetings shall be conducted in such
a manner that all members are afforded an adequate opportunity to present their
views. All opinions shall be considered
before actions are voted upon. The
officers shall undertake this responsibility with the assistance of the
secretariat's staff.
c)
Discussions shall be confined to technical, engineering and
safety factors. Commercial
considerations (warranties, guarantees, etc.) are not proper factors and shall
not be considered. Since the DICOM
Standard is voluntary, there must be no agreement to adhere to it or any
discussions as to when members will begin to offer products conforming to
DICOM.
d)
The secretariat shall ensure that minutes of all meetings
are clear, complete, and accurate with regard to the actions that were taken
and the justification for those actions.
e)
There shall be no conversations "off the record"
at a Committee or subgroup meetings. If
comments are not appropriate for recording, they shall not be brought up at
meetings.
f)
Committee and subgroup meetings shall be adjourned when all
business has been completed. Informal
"rump" sessions are not part of Committee or subgroup meetings and
should not be held.
6.2
Meeting Conduct for Biomedical Organization Members
The
objective of these rules is to create a neutral ground at meetings of the
Committee or its subgroups for the biomedical professionals and their influence
on vendors.
a)
Members and non-members who attend meetings shall
understand that the main goal of the Committee is to develop standards for
medical imaging communications and related technologies in the healthcare
domain.
b)
Potentially contentious issues of professional control over
an imaging technique or the resulting images (e.g., who should perform
examinations and interpret the resulting images and who should bill for the
professional services rendered) are outside the scope of work of the Committee
and shall not be topics for discussion at meetings of the Committee or its
subgroups.
c)
Discussion of professional practice regarding imaging and
interpretation shall be permitted provided that they are described in the
context of professional practice as conducted in a particular institution. Such discussions shall be permitted for the
purposes of generalizing information models, when requested for clarification
by manufacturers or other professional societies. They are also justified when Committee or subgroup consensus is
that such a discussion is materially important to the task at hand and does not
represent a particular professional society's desire to advance its own goals
for medical imaging to the detriment of other organizations.
In accordance with item a), a biomedical professional
organization or group of such organizations shall not attempt to direct standards
development in the DICOM Standards Committee or its subgroups to further their
own goals to the disadvantage of other biomedical professional organizations.
These rules are in addition to, not in lieu of, the
secretariat's rules for conduct of meetings. These rules shall apply
irrespective of the organization serving as secretariat for the meeting.
7
Voting
Each
member shall vote one of the following positions:
a)
Affirmative;
b)
Affirmative, with comment;
c)
Negative, with reasons (the reasons for a negative vote
shall be given and if possible should include specific wording or actions that
would resolve the objection); or
d)
Abstain.
An
alternate's vote is counted only if the principal representative fails to
vote. If none of these representatives
is able to attend, the organization they represent may designate someone else
to cast the vote for the organization.
This designation shall be documented by a written proxy from either the
member’s principal or alternate representative.
7.1
Single Vote
Generally,
no representative shall have more than one vote. However, if two or more members appoint the same individual to
represent each of them, that individual may cast a separate vote for each
organization represented. The
organizations shall confirm in writing to the secretariat that they are aware
of and will accept the results.
7.2
Quorum
A
majority of the members of the Committee with voting rights or a majority of
members of subgroups with voting rights shall constitute a quorum for
conducting business at a meeting.
Voting rights are described in Section 2.2.4 and Section 4.2.
If a
quorum is not present, actions may be taken subject to confirmation by letter
ballot or future approval of the minutes of the meeting.
7.3
Actions Requiring Approval by a Majority
The
following actions require approval by a majority of the membership present at a
meeting where a quorum is present:
a)
Election of officers and at-large members of the Executive
Committee;
b)
Formation of a subgroup, including its procedures, scope,
and duties;
c)
Approval of new standardization projects;
d)
Appointment of subgroup members who are not members of the
Committee;
e)
Disbandment of subgroups;
f)
Addition of new Committee members and designation of their
interest categories;
g)
Approval of minutes and
h)
Other actions not specifically described in these
procedures.
Action
on items not published in the meeting agenda, may be postponed until a future
meeting at the discretion of the officers and the secretariat.
7.4
Actions Requiring Two Thirds Approval
The
following actions require a letter ballot or an equivalent recorded vote:
a) Adoption of Committee procedures, interest categories,
or revisions thereof;
b) Approval of new standards or supplements to an existing
standard;
c) Approval of, reaffirmation, or withdrawal of an existing
standard;
d) Approval of change of Committee scope;
e) Approval of termination of the Committee; and
f) Recall of officers.
Recorded
votes on these actions at a Committee meeting require approval by at least a
majority of the membership with voting rights and at least two-thirds of those
voting affirmative or negative.
These
actions shall not be taken at a Committee meeting unless the published agenda
for the meeting stated that action was on the agenda and that a vote on the
action was expected.
Letter
ballots require approval by two-thirds of those voting affirmative or negative
and return of more than one-half of the ballots sent to members in good
standing relative to letter ballots.
Members
are not in good standing relative to letter ballots if they (or their
alternate) have not responded to two consecutive letter ballots of the
Committee. Members not in good standing
will continue to receive and may vote on subsequent letter ballots.
7.5
Letter Ballot Voting
A
letter ballot may be authorized by any of the following:
a) A majority vote of those present at a Committee meeting;
b) Either co-chair;
c) The secretariat and
d) A petition by five or more members of the Committee.
Except
for approval of standards, the voting period for letter ballots shall end 30
days from the date of issue or as soon as all ballots are returned, whichever
comes earlier. An extension may be
granted at the option of either co-chair, when warranted.
A
follow-up letter requesting immediate return of the ballot shall be sent, as
appropriate, to members and alternate members whose votes have not been
received within ten working days before the ballot closes.
8
Standardization Project Phases
Standardization
projects shall be conducted in the following phases.
a) Requirements Definition (optional),
b) Early Draft,
c) Public Comment Draft,
d) Intermediate Draft,
e) Trial-Use Draft (optional),
f) Letter-Ballot Text and
g) Final Text.
All
draft standards shall be identified with one of the names in items b) through
f) above.
8.1
Requirements Definition (optional)
The
proposal to begin this phase should contain:
·
A title under which the extension is identified;
·
A description of the application and an explanation why
this application cannot be handled by the present standard;
·
A prediction of the parts of the standard which will be
influenced by the proposed extension; and
·
An estimate of the required capacity and expertise in the
subgroup responsible for the project and other subgroups, such as the Base
Standard Working Group.
During
this phase, a detailed proposal of the scope of the project, subgroup
resources, and timeframe for completion is prepared. This phase should be completed in no more than two meetings of
the subgroup.
The
Committee may decide that this phase is not required if the project is
relatively small. In this case, the
Committee may approve starting with the Early Draft phase.
Approval
for a project to begin this phase requires a majority vote of the Committee.
8.2
Early Draft
The
proposal to begin this phase shall contain either the detailed proposal
prepared in the Requirements Definition Phase or a brief proposal as described
in Section 8.1.
Approval
for a project to begin this phase requires a majority vote of the Committee.
During
this phase, the initial drafts of the standard or supplement are prepared.
This
phase is completed when the:
·
Subgroup prepares a Public Comment Draft of the proposed
standard and
·
Public Comment Draft is approved by the Base Standards
Working Group.
8.3
Public Comment Draft
The
time that the document is in the public comment draft is called the Public
Comment Period. The Public Comment
Period shall be at least 45 days.
During this period, the proposed standard is submitted to a group of
interested parties outside the Committee and to other interested subgroups that
report to the Committee. The
originating subgroup shall make an effort to identify all interested parties
worldwide.
8.4 Intermediate Draft
This
phase begins following the public comment period.
During
this phase the subgroup addresses all comments received and prepares revised
drafts of the proposed standard.
The
subgroup shall make a recommendation to the Base Standard Working Group
regarding whether the proposed standard should go through the Trial-Use Draft
Phase or move directly to the Letter-Ballot Phase. The Base Standard Working Group shall make the final decision.
This
phase is completed when the:
·
Subgroup prepares either a Trial-Use Draft or Letter-Ballot
Text and
·
Document is approved by the Base Standard Working Group.
8.5
Trial-Use Draft (optional)
This
phase begins when the Trial-Use Draft is approved by the Base Standard Working
Group.
The
purpose of this phase is to provide a stable draft of the proposed standard to
encourage prototype implementations. It
shall be used when it is believed that implementation experience is needed
before the content of the proposed standard can be finalized and submitted for
letter ballot.
During
this phase, changes to the Trial-Use Draft shall only be made following a
well-documented change process that is maintained by the subgroup responsible
for the proposed standard.
The
following statement, or equivalent, shall be included on the front cover of the
draft standard:
"Publication
of this Draft Standard for trial use and comment has been approved by the Base
Standard Working Group of the DICOM Standards Committee. Distribution of this draft standard for
comment shall not continue beyond ( ) months from the date of publication. It is expected, but not certain, that
following this ( ) month period, this draft standard, revised as necessary,
will be submitted to the DICOM Standards Committee for approval as an addition
to the DICOM Standard. Suggestions for
revision should be directed to ...."
This
phase is completed when:
·
The subgroup determines that sufficient input has been
obtained;
·
It prepares a Letter-Ballot Draft; and
·
The Letter-Ballot Text is approved by the Base Standard
Working Group.
8.6
Letter-Ballot Text
Following
approval of the Letter-Ballot Text, the secretariat and either co-chair shall
authorize a letter ballot of the members of the Committee. This letter ballot shall have a 49-day time
limit.
Following
the letter ballot, the Base Standard Working Group shall consider all comments
from the letter ballot according to the secretariat's procedures. It may prepare a final proposed standard
(Final Text) and an explanation of how each comment was resolved. These shall be submitted to the secretariat
and officers of the Committee.
Alternatively,
the Base Standard Working Group may decide to submit the proposed standard to
the subgroup that developed the standard for further action.
8.7
Final Text
If
the secretariat and either co-chair determine that all comments received during
the letter ballot have been addressed according to these procedures and if
there are no technical differences that directly and materially affect the use
of the standard between the Letter-Ballot Text and the Final Text, then, the
standard is approved.
If
the secretariat and either co-chair determine that there are only minor
technical differences between the Letter-Ballot Text and the Final Text, the
secretariat shall inform all members of the Committee regarding the nature of
the changes. Each member shall be given
a 30-day opportunity to change its vote.
At the conclusion of this period, the secretary shall recount the votes
and determine whether, in view of these changes, the standard is approved or
rejected.
If
the secretariat and either co-chair determine that there are major technical differences
between the Letter-Ballot Text and the Final Text, another ballot will be
required.
9.
PATENT DISCLOSURE POLICY
9.1
Purpose
Numerous
technologies are required for the effective implementation of the DICOM
Standard. When it is both possible and practical,
such technologies should be available for public use; however, both the DICOM
Standards Committee (“the Committee”) and its Secretariat, the National
Electrical Manufacturers Association, recognize that Members of the Committee
(including its subdivisions and working groups) may hold patents or patent
applications for technology that, for sound technical reasons, are required to
implement the DICOM Standard. The
Committee, in connection with its efforts to develop and update the DICOM
Standard, would prefer to know, in advance of the development or revision of
the DICOM Standard, whether there are claims of a patent or pending patent
application, which users seeking to conform to the DICOM Standard would be
required to practice, so that informed decisions can be made by the Committee,
its subdivisions or working groups about whether to incorporate proprietary
technology in the DICOM Standard. On
the other hand, the Committee recognizes the difficulty that some Members may
have in monitoring and searching patent portfolios in view of an evolving
Standard. The Committee also recognizes
that the actual participants in the Committee, or its subdivisions and working
groups, may not be familiar with the patents and patent applications of their
respective employers or affiliated firms.
To meet these competing concerns of the Committee, the users of the
DICOM Standard, and the holders of patent rights, the Committee adopts the
following policy:
9.2
No Duty to Search Patent Portfolio
Committee
Members do not have an affirmative duty to search a patent portfolio to
determine if they own a patent or patent application whose claims are required
to implement the DICOM Standard.
9.3
Duty of Good Faith to Disclose Known Inventions Required to Implement the DICOM
Standard
Subject
to the above, Members have an affirmative duty to act in good faith toward the
Committee and its other Members to bring to the attention of the Committee any
patents or patent applications (where disclosure of the latter would not prejudice
the intellectual property rights of an applicant), owned by the Member (or an
employer, parent company, subsidiary or affiliate of the Member) and known to
the Member that practicing one or more claims of a patent or patent application
is required to implement any portion of the DICOM Standard or a revision
thereof that is proposed for adoption.
No Member shall knowingly conceal from the Committee any patents or
patent applications owned by it (or any employer, parent company, subsidiary or
affiliate of a Member) where practicing the claimed invention(s) is required by
a user of the DICOM Standard to conform to the DICOM Standard and any revision
thereof that is proposed for adoption.
The
Committee further adopts a requirement that each of its Members execute a
Declaration in the form set forth below to ensure fair use of the DICOM
Standard, which includes a commitment by the Members to make available
inventions subject to a patent or patent application that are required to be
practiced by a user of the DICOM Standard in order to conform to the DICOM
Standard, on terms described in the Declaration, and subject to a condition of
reciprocity. As used herein,
“reciprocity” means that with respect to other parties that have a patent or
patent application required in the use of the DICOM Standard, the Member shall
only be required to license to such parties if they are willing to license
their patent or patent applications on the terms provided in the Declaration.
9.4
Timing of Disclosure
The
Duty of Good Faith includes a requirement that the disclosure to be made by the
Member under this Policy shall be made to the Secretariat of the Committee as
expeditiously as possible after the Member recognizes the obligation of
disclosure. The disclosure shall be made
in a manner as prescribed by the Committee, including any documentation
required by the Committee.
9.5
Definitions
The term “Member” as used in this Policy refers to any organization that has been elected membership in the DICOM Standards Committee and to any organization or individual that was appointed by the DICOM Standards Committee as a member or participant in one or more of the DICOM Standards Committee’s