Regulatory cooperation between the EU and the US on standardization and regulation of RFID technology and electronic health record systems

Dear Madams & Sirs,

Under the right of access to documents in the EU treaties, as developed in Regulation 1049/2001, I am requesting documents which contain the following information concerning regulatory cooperation between the EU and the US on standardization and regulation of RFID technology and electronic health record systems (since January 2003):

1) minutes and other reports of meetings between European Commission officials and/or representatives (including the Commissioner and the Cabinet) with their United States counterparts on standardization and regulation of RFID technology and electronic health record systems (since January 2003).

2) all correspondence (including emails, letters) of European Commission officials and/or representatives (including the Commissioner and the Cabinet) with their United States counterparts on standardization and regulation of RFID technology and electronic health record systems (since January 2003).

3) minutes and other reports of meetings between European Commission officials and/or representatives (including the Commissioner and the Cabinet) and representatives of companies and business associations on standardization and regulation of RFID technology and electronic health record systems (since January 2003).

Yours faithfully,

Hans Diels

University of Antwerp
Akkerstraat 10
2500 Lier

Communications Networks, Content and Technology

Your message has been received by the Transparency Unit of the
Secretariat-General of the European Commission.
Requests for public access to documents are treated on the basis of
[1]Regulation (EC) No 1049/2001 of 30 May 2001 regarding public access to
European Parliament, Council and Commission documents.
The Secretariat-General will reply to your request within 15 working days
upon registration of your request and will duly inform you of the
registration of the request (or of any additional information to be
provided in view of its registration and/or treatment).
 
 
L’unité «Transparence» du secrétariat général de la Commission européenne
a bien reçu votre message.
Les demandes d’accès du public aux documents sont traitées sur la base du
[2]règlement (CE) n° 1049/2001 du 30 mai 2001 relatif à l’accès du public
aux documents du Parlement européen, du Conseil et de la Commission.
Le secrétariat général répondra à votre demande dans un délai de 15 jours
ouvrables à compter de la date d’enregistrement de votre demande, et vous
informera de cet enregistrement (ou vous indiquera toute information
supplémentaire à fournir en vue de l'enregistrement et/ou du traitement de
votre demande).
 
 
Ihre Nachricht ist beim Referat „Transparenz“ des Generalsekretariats der
Europäischen Kommission eingegangen.
Anträge auf Zugang zu Dokumenten werden auf der Grundlage der
[3]Verordnung (EG) Nr. 1049/2001 vom 30. Mai 2001 über den Zugang der
Öffentlichkeit zu Dokumenten des Europäischen Parlaments, des Rates und
der Kommission behandelt.
Das Generalsekretariat beantwortet Ihre Anfrage innerhalb von
15 Arbeitstagen nach deren Registrierung und wird Sie über die
Registrierung Ihres Antrags (oder die Notwendigkeit weiterer Informationen
im Hinblick auf dessen Registrierung und/oder Bearbeitung) unterrichten.
 
 

References

Visible links
1. https://eur-lex.europa.eu/legal-content/...
2. https://eur-lex.europa.eu/legal-content/...
3. https://eur-lex.europa.eu/legal-content/...

ve_sg.accessdoc (SG), Communications Networks, Content and Technology

[1]Ares(2020)581768 - RE: access to documents request - Regulatory
cooperation between the EU and the US on standardization and regulation of
RFID technology and electronic health record systems--Ref. Gestdem
2020/550

Sent by ve_sg.accessdoc (SG) <[DG CONNECT request email]>. All responses have
to be sent to this email address.
Envoyé par ve_sg.accessdoc (SG) <[DG CONNECT request email]>. Toutes les
réponses doivent être effectuées à cette adresse électronique.

Dear Sir,

Thank you for your e-mail dated 30/01/2020. We hereby acknowledge receipt
of your application for access to documents, which was registered on
30/01/2020 under reference number GestDem 2020/550.

In accordance with Regulation (EC) No 1049/2001 regarding public access to
European Parliament, Council and Commission documents, your application
will be handled within 15 working days.

The time limit will expire on 20/02/2020. In case this time limit needs to
be extended, you will be informed in due course.

You have lodged your application via the AsktheEU.org website. Please note
that this is a private third-party website which has no link with any
institution of the European Union. Therefore, the European Commission
cannot be held accountable for any technical issues or problems linked to
the use of this system.

Please note that the private third party running the AsktheEU.org website
is responsible and accountable for the processing of your personal data
via that website, and not the European Commission. For further information
on your rights, please refer to the third party’s privacy policy.

We understand that the third party running that website usually publishes
the content of applicants’ correspondence with the European Commission on
that website. This includes the personal data that you may have
communicated to the European Commission (e.g. your private postal
address).

Similarly, the third party publishes on that website any reply that the
Commission will send to the email address of the applicants generated by
the AsktheEU.org website.

If you do not wish your correspondence with the European Commission to be
published on the AsktheEU.org website, you can provide us with an
alternative, private e-mail address for further correspondence.

In that case, the European Commission will send all future electronic
correspondence addressed to you only to that private address.

Yours faithfully,

Access to documents team (RC)
SG.C.1
Transparency

show quoted sections

ve_cnect.public_access_to_documents (CNECT), Communications Networks, Content and Technology

1 Attachment

Link: [1]File-List
Link: [2]Edit-Time-Data
Link: [3]themeData
Link: [4]colorSchemeMapping

[5]Ares(2020)932894 - Your application for access to documents –GestDem
2020/0550 - Clarification's request

Sent by ve_cnect.public_access_to_documents (CNECT)
<[email address]>. All responses have to be
sent to this email address.
Envoyé par ve_cnect.public_access_to_documents (CNECT)
<[email address]>. Toutes les réponses
doivent être effectuées à cette adresse électronique.

Dear Mr Diels

We refer to your e-mail, dated 30/01/2020, in which you make a request for
access to documents pursuant to Regulation (EC) No 1049/2001 of the
European Parliament and of the Council of 30 May 2001 regarding public
access to European Parliament, Council and Commission documents
(hereinafter ‘Regulation 1049/2001’), registered on the same date under
the above-mentioned reference number. 

Your application reads as follows:

‘Under the right of access to documents in the EU treaties, as developed
in Regulation 1049/2001, I am requesting documents which contain the
following information concerning regulatory cooperation between the EU and
the US on standardization and regulation of RFID technology and electronic
health record systems (since January 2003):

 

1) minutes and other reports of meetings between European Commission
officials and/or representatives (including the Commissioner and the
Cabinet) with their United States counterparts on standardization and
regulation of RFID technology and electronic health record systems (since
January 2003).

 

2) all correspondence (including emails, letters) of European Commission
officials and/or representatives (including the Commissioner and the
Cabinet) with their United States counterparts on standardization and
regulation of RFID technology and electronic health record systems (since
January 2003).

 

3) minutes and other reports of meetings between European Commission
officials and/or representatives (including the Commissioner and the
Cabinet) and representatives of companies and business associations on
standardization and regulation of RFID technology and electronic health
record systems (since January 2003).’

The description given in your application does not enable us to identify
specific documents corresponding to your request. We therefore invite you,
pursuant to Article 6(2) of Regulation 1049/2001 regarding public access
to documents, to clarify the relation of ‘RFID technology’ and ‘electronic
health record systems’. Could you please clarify if the request relates to
RFID technology in so far as it is relevant for electronic health record
systems, or if it concerns regulatory cooperation of the EU and US for
RFID and to regulatory cooperation of the EU and US for electronic health
record systems.

We kindly ask you to reply by email to:
[6][email address]

In accordance with Article 2, third paragraph of the Implementing Rules to
Regulation 1049/2001, the 15 working days time limit for handling your
application will start running when we receive the requested
clarifications.

 Thank you in advance for your understanding. 

 Yours faithfully,

 DG CONNECT ACCESS TO DOCUMENTS Team

 

[7]cid:image001.png@01D46222.1AC4EB30
European Commission
DG CONNECT/R4 - ACCESS TO DOCUMENTS

1049 Brussels

BELGIUM

 

 

 

 

References

Visible links
1. file:///tmp/cid:filelist.xml@01D5E261.DDD75700
2. file:///tmp/cid:editdata.mso
3. file:///tmp/~~themedata~~
4. file:///tmp/~~colorschememapping~~
5. https://webgate.ec.testa.eu/Ares/documen...
6. mailto:[email address]

Dear Connect,

My request relates to regulatory cooperation of the EU and US for
RFID and to regulatory cooperation of the EU and US for electronic health
record systems.

Yours sincerely,

Hans Diels

Dear DG Connect,

My request concerns regulatory cooperation of the EU and US on
RFID and regulatory cooperation of the EU and US on electronic health
record systems.

Yours sincerely,

Hans Diels

ve_cnect.public_access_to_documents (CNECT), Communications Networks, Content and Technology

1 Attachment

Link: [1]File-List
Link: [2]Edit-Time-Data
Link: [3]themeData
Link: [4]colorSchemeMapping

[5]Ares(2020)1212213 - Gestdem 2020/0550 - Fair solution proposal

Sent by ve_cnect.public_access_to_documents (CNECT)
<[email address]>. All responses have to be
sent to this email address.
Envoyé par ve_cnect.public_access_to_documents (CNECT)
<[email address]>. Toutes les réponses
doivent être effectuées à cette adresse électronique.

Dear Mr Diels

We refer to your e-mail, dated 30/01/2020, in which you make a request
for  access to documents pursuant to Regulation (EC) No 1049/2001 of the
European Parliament and of the Council of 30 May 2001 regarding public
access to European Parliament, Council and Commission documents
(hereinafter ‘Regulation 1049/2001’), registered on the same date under
the above-mentioned reference number. 

In your application reads as follows:

‘Under the right of access to documents in the EU treaties, as developed
in Regulation 1049/2001, I am requesting documents which contain the
following information concerning regulatory cooperation between the EU and
the US on standardization and regulation of RFID technology and electronic
health record systems (since January 2003):

1) minutes and other reports of meetings between European Commission
officials and/or representatives (including the Commissioner and the
Cabinet) with their United States counterparts on standardization and
regulation of RFID technology and electronic health record systems (since
January 2003).

2) all correspondence (including emails, letters) of European Commission
officials and/or representatives (including the Commissioner and the
Cabinet) with their United States counterparts on standardization and
regulation of RFID technology and electronic health record systems (since
January 2003).

3) minutes and other reports of meetings between European Commission
officials and/or representatives (including the Commissioner and the
Cabinet) and representatives of companies and business associations on
standardization and regulation of RFID technology and electronic health
record systems (since January 2003).’

We also refer to your email, dated 17/02/2020, in which you clarified to
be interested in

a)      concerns regulatory cooperation of the EU and US on RFID and

b)      regulatory cooperation of the EU and US on electronic health
record systems

Due to the wide scope of your request, namely from a temporal point of
view, its handling would involve the search and assessment of many
documents older than 10 year which have been already transferred to the
central archives. The work needed to deal with your application would
cover the following steps:

- Multiple searches for the identification of the documents which fall
within the scope of the request in several document management systems,

- Retrieval and establishment of a complete list of the documents falling
under the scope of your requests, 

- Scanning of the documents which are not in pdf format,

- Preliminary individual Assessment of the content of the documents in
light of the exceptions contained in Article 4 of Regulation 1049/2001,

- Third party consultations under Article 4(4) and / or 4(5) of Regulation
1049/2001,

- Final assessment of the documents in light of the comments received,

- Redaction of those parts of the documents to which one or several
exceptions apply,

- Preparation of the draft reply,

 - Finalisation of the reply at administrative level and formal approval
of the draft decision

- Preparation of the reply and the documents for dispatch. 

As the request relates to correspondence, minutes and other reports of
meetings held between 2003 and 2020, the work needed for the treatment of
your requests cannot expected to be completed within the normal time
limits set out in Article 7 of Regulation 1049/2001.

Article 6(3) of the Regulation 1049/2001 provides that, in the event of an
application relating to very large number of documents, the institution
concerned may confer with the applicant informally with a view to finding
a fair solution. In accordance with the case law of the Union Courts, the
proposal for a fair solution aims to balance the interest of the applicant
against the workload resulting from the processing of the application in
order to safeguard the interests of good administration (Judgments of 6
December 2001, Council v Hautala, Case C 353/99 P, EU:C:2001: 661, para.
30, and of 2 October 2014, Strack v Commission, Case C 127/13 P,
EU:C:2014:2250, para.27). Such solution can only concern the content or
the number of documents applied for, not the deadline for replying
(Judgment of the Court of Justice of 2 October 2014 in case C- 127/13,
Guido Strack v Commission, paragraphs 26-28). This means that the scope of
the request must be reduced in a way that would enable its treatment
within the extended deadline of 15 + 15 working days. This also excludes
the provision of documents on a rolling basis.

Based on the above, we would kindly ask you to specify the objective of
your request, your specific interest in the requested documents and to
narrow down the scope of your request (namely the timeframe covered), so
as to reduce it to a manageable amount of documents.

According to our first estimates and taking into account the other ‘access
to documents’ requests being handled within DG CONNECT at the same time,
the global workload of the concerned staff during the same period, the
human resources available and the need to safeguard good administration,
we estimate that only a maximum of 20 documents can be dealt with in the
remaining time. We therefore kindly ask you to specify the documents you
are interested.

In order to help you to narrow down your request, please note that from a
first search in our databases we have already identified almost 20-30
documents dated from 2008 and falling within the scope of your request.
These documents are mainly belonging to the category of correspondence
between Commission’s officials and US counterparts concerning:

a)       the discussions regarding the Memorandum of Understanding (MoU)
with the US on cooperation surrounding health related ICT signed in
December 2010. The MoU was then followed in the spring of 2013 by the
publication by DG CNECT and the US Department of Health and Human Services
(HHS) of a first Roadmap of MoU actions.

b)      the discussions regarding the Communication published in 2011 on
RFID.

Please note that even after reducing the scope of your request to the last
12 years, it is possible that the number of documents is still
significantly higher than 20 and would need to be reduced further. We
therefore invite you to specify the objectives for which you are making
the request to allow us to identify the documents you are most interested
in.

In order to enable us to respect the time limits of Regulation 1049/2001,
we would ask you for a swift response to our proposal for a fair solution
to limit the search to relevant documents dated as from 2008 for point a)
and as from 2010 for point b). Please respond within three working days at
the latest. Please send your response by email to the following address:
[6][email address]

In the absence of a reply within three working days, we will unilaterally
restrict the scope of your applications to those parts that can be dealt
with within the extended deadline of 30 working days counting from the
date of registration of your application.

 Thank you in advance for your cooperation.

 DG CONNECT ACCESS TO DOCUMENTS Team

 

[7]cid:image001.png@01D46222.1AC4EB30
European Commission
DG CONNECT/R4 - ACCESS TO DOCUMENTS

1049 Brussels

BELGIUM

 

 

 

 

References

Visible links
1. file:///tmp/cid:filelist.xml@01D5ECCA.1AF6ABA0
2. file:///tmp/cid:editdata.mso
3. file:///tmp/~~themedata~~
4. file:///tmp/~~colorschememapping~~
5. https://webgate.ec.testa.eu/Ares/documen...
6. mailto:[email address]

Dear ve_cnect.public_access_to_documents (CNECT),

Can you focus the document search on:
- E-Health: Reports of meetings between EU and US officials in preparation of the 2010 MoU and the 2013 Roadmap. In the roadmap, I'm interested in the workstream on standards development.
- RFID: Reports of meetings between EU and US officials in preparation of the Communication published in 2011 on RFID.

Yours sincerely,

Hans Diels

ve_cnect.public_access_to_documents (CNECT), Communications Networks, Content and Technology

1 Attachment

Link: [1]File-List
Link: [2]Edit-Time-Data
Link: [3]themeData
Link: [4]colorSchemeMapping

[5]Ares(2020)1400280 - Your access to document application - Gestdem
2020/0550 - Holding reply

Sent by ve_cnect.public_access_to_documents (CNECT)
<[email address]>. All responses have to be
sent to this email address.
Envoyé par ve_cnect.public_access_to_documents (CNECT)
<[email address]>. Toutes les réponses
doivent être effectuées à cette adresse électronique.

Dear Mr Diels,

We refer to your access to documents request dated 30/01/2020 and
registered on the same day under the above mentioned reference number. We
also refer to your reply dated 13/02/2020 to our clarification request on
which basis the time limit to reply to your application has been
recalculated and fixed at the 06/03/2020.

Your application is currently being handled. However, we will not be in a
position to complete the handling of your application within the time
limit of 15 working days, which expires today.

An extended time limit is needed as the documents identified following the
fair solution agreement concerns several services which need to be
consulted.

Therefore, we have to extend the time limit with 15 working days in
accordance with Article 7(3) of Regulation (EC) No 1049/2001 regarding
public access to documents. The new time limit expires on 27/03/2020.

We apologise for this delay and for any inconvenience this may cause.

Yours faithfully,

 

Access to Documents Team

 

[6]cid:image001.png@01D3AF19.959C0670

European Commission

DG Connect – ACCESS TO DOCUMENTS

BU25 – Avenue de Beaulieu 25

B-1160 Brussels/Belgium

 

References

Visible links
1. file:///tmp/cid:filelist.xml@01D5F2E6.3C822660
2. file:///tmp/cid:editdata.mso
3. file:///tmp/~~themedata~~
4. file:///tmp/~~colorschememapping~~
5. https://webgate.ec.testa.eu/Ares/documen...

ve_cnect.public_access_to_documents(CNECT), Communications Networks, Content and Technology

1 Attachment

Advance copy by e-mail and registered mail with acknowledgement of receipt

Dear Mr Diels,

Please find attached document Ares(2020)1799190 regarding "Reply to your access to document request - GESTDEM 2020/0550" sent by Mr Roberto Viola, General Director of DG CONNECT on 27/03/2020.

Best regards,

European Commission
DG CONNECT — ACCESS TO DOCUMENTS
Avenue de Beaulieu, 25
B-1160 Brussels/Belgium