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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">A Tamper-Resistant and Portable Healthcare Folder</title>
<author><name sortKey="Anciaux, Nicolas" sort="Anciaux, Nicolas" uniqKey="Anciaux N" first="Nicolas" last="Anciaux">Nicolas Anciaux</name>
<affiliation><nlm:aff id="I1">Institut National de Recherche en Informatique et en Automatique (INRIA), Rocquencourt, 78153 Le Chesnay Cedex, France</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Berthelot, Morgane" sort="Berthelot, Morgane" uniqKey="Berthelot M" first="Morgane" last="Berthelot">Morgane Berthelot</name>
<affiliation><nlm:aff id="I2">SANTEOS SA, Tour Manhattan, 5,6 Place de l'Iris, 92926 Paris la Défense Cedex, France</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Braconnier, Laurent" sort="Braconnier, Laurent" uniqKey="Braconnier L" first="Laurent" last="Braconnier">Laurent Braconnier</name>
<affiliation><nlm:aff id="I3">Conseil Général des Yvelines, Hôtel du Département, 2 Place André Mignot, 78012 Versailles Cedex, France</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Bouganim, Luc" sort="Bouganim, Luc" uniqKey="Bouganim L" first="Luc" last="Bouganim">Luc Bouganim</name>
<affiliation><nlm:aff id="I1">Institut National de Recherche en Informatique et en Automatique (INRIA), Rocquencourt, 78153 Le Chesnay Cedex, France</nlm:aff>
</affiliation>
</author>
<author><name sortKey="De La Blache, Martine" sort="De La Blache, Martine" uniqKey="De La Blache M" first="Martine" last="De La Blache">Martine De La Blache</name>
<affiliation><nlm:aff id="I3">Conseil Général des Yvelines, Hôtel du Département, 2 Place André Mignot, 78012 Versailles Cedex, France</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Gardarin, Georges" sort="Gardarin, Georges" uniqKey="Gardarin G" first="Georges" last="Gardarin">Georges Gardarin</name>
<affiliation><nlm:aff id="I4">PRISM Laboratory, University of Versailles, 45 avenue des Etats-Unis, 78035 Versailles Cedex, France</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Kesmarszky, Philippe" sort="Kesmarszky, Philippe" uniqKey="Kesmarszky P" first="Philippe" last="Kesmarszky">Philippe Kesmarszky</name>
<affiliation><nlm:aff id="I5">Association Locale de Développement Sanitaire (ALDS ), 25 avenue des Aulnes, 78250 Meulan, France</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Lartigue, Sophie" sort="Lartigue, Sophie" uniqKey="Lartigue S" first="Sophie" last="Lartigue">Sophie Lartigue</name>
<affiliation><nlm:aff id="I6">Coordination Gérontologique Intercommunale du Territoire Est Yvelines (CoGITEY), 6 avenue du Maréchal Franchet d'Esperey, 78004 Versailles, France</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Navarre, Jean Francois" sort="Navarre, Jean Francois" uniqKey="Navarre J" first="Jean-François" last="Navarre">Jean-François Navarre</name>
<affiliation><nlm:aff id="I3">Conseil Général des Yvelines, Hôtel du Département, 2 Place André Mignot, 78012 Versailles Cedex, France</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Pucheral, Philippe" sort="Pucheral, Philippe" uniqKey="Pucheral P" first="Philippe" last="Pucheral">Philippe Pucheral</name>
<affiliation><nlm:aff>NONE</nlm:aff>
</affiliation>
<affiliation><nlm:aff>NONE</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Vandewalle, Jean Jacques" sort="Vandewalle, Jean Jacques" uniqKey="Vandewalle J" first="Jean-Jacques" last="Vandewalle">Jean-Jacques Vandewalle</name>
<affiliation><nlm:aff id="I7">Gemalto, 6 rue de la Verrerie, 92190 Meudon, France</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Zeitouni, Karine" sort="Zeitouni, Karine" uniqKey="Zeitouni K" first="Karine" last="Zeitouni">Karine Zeitouni</name>
<affiliation><nlm:aff id="I4">PRISM Laboratory, University of Versailles, 45 avenue des Etats-Unis, 78035 Versailles Cedex, France</nlm:aff>
</affiliation>
</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">PMC</idno>
<idno type="pmid">18615200</idno>
<idno type="pmc">2443680</idno>
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<idno type="doi">10.1155/2008/763534</idno>
<date when="2008">2008</date>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">A Tamper-Resistant and Portable Healthcare Folder</title>
<author><name sortKey="Anciaux, Nicolas" sort="Anciaux, Nicolas" uniqKey="Anciaux N" first="Nicolas" last="Anciaux">Nicolas Anciaux</name>
<affiliation><nlm:aff id="I1">Institut National de Recherche en Informatique et en Automatique (INRIA), Rocquencourt, 78153 Le Chesnay Cedex, France</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Berthelot, Morgane" sort="Berthelot, Morgane" uniqKey="Berthelot M" first="Morgane" last="Berthelot">Morgane Berthelot</name>
<affiliation><nlm:aff id="I2">SANTEOS SA, Tour Manhattan, 5,6 Place de l'Iris, 92926 Paris la Défense Cedex, France</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Braconnier, Laurent" sort="Braconnier, Laurent" uniqKey="Braconnier L" first="Laurent" last="Braconnier">Laurent Braconnier</name>
<affiliation><nlm:aff id="I3">Conseil Général des Yvelines, Hôtel du Département, 2 Place André Mignot, 78012 Versailles Cedex, France</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Bouganim, Luc" sort="Bouganim, Luc" uniqKey="Bouganim L" first="Luc" last="Bouganim">Luc Bouganim</name>
<affiliation><nlm:aff id="I1">Institut National de Recherche en Informatique et en Automatique (INRIA), Rocquencourt, 78153 Le Chesnay Cedex, France</nlm:aff>
</affiliation>
</author>
<author><name sortKey="De La Blache, Martine" sort="De La Blache, Martine" uniqKey="De La Blache M" first="Martine" last="De La Blache">Martine De La Blache</name>
<affiliation><nlm:aff id="I3">Conseil Général des Yvelines, Hôtel du Département, 2 Place André Mignot, 78012 Versailles Cedex, France</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Gardarin, Georges" sort="Gardarin, Georges" uniqKey="Gardarin G" first="Georges" last="Gardarin">Georges Gardarin</name>
<affiliation><nlm:aff id="I4">PRISM Laboratory, University of Versailles, 45 avenue des Etats-Unis, 78035 Versailles Cedex, France</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Kesmarszky, Philippe" sort="Kesmarszky, Philippe" uniqKey="Kesmarszky P" first="Philippe" last="Kesmarszky">Philippe Kesmarszky</name>
<affiliation><nlm:aff id="I5">Association Locale de Développement Sanitaire (ALDS ), 25 avenue des Aulnes, 78250 Meulan, France</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Lartigue, Sophie" sort="Lartigue, Sophie" uniqKey="Lartigue S" first="Sophie" last="Lartigue">Sophie Lartigue</name>
<affiliation><nlm:aff id="I6">Coordination Gérontologique Intercommunale du Territoire Est Yvelines (CoGITEY), 6 avenue du Maréchal Franchet d'Esperey, 78004 Versailles, France</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Navarre, Jean Francois" sort="Navarre, Jean Francois" uniqKey="Navarre J" first="Jean-François" last="Navarre">Jean-François Navarre</name>
<affiliation><nlm:aff id="I3">Conseil Général des Yvelines, Hôtel du Département, 2 Place André Mignot, 78012 Versailles Cedex, France</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Pucheral, Philippe" sort="Pucheral, Philippe" uniqKey="Pucheral P" first="Philippe" last="Pucheral">Philippe Pucheral</name>
<affiliation><nlm:aff>NONE</nlm:aff>
</affiliation>
<affiliation><nlm:aff>NONE</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Vandewalle, Jean Jacques" sort="Vandewalle, Jean Jacques" uniqKey="Vandewalle J" first="Jean-Jacques" last="Vandewalle">Jean-Jacques Vandewalle</name>
<affiliation><nlm:aff id="I7">Gemalto, 6 rue de la Verrerie, 92190 Meudon, France</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Zeitouni, Karine" sort="Zeitouni, Karine" uniqKey="Zeitouni K" first="Karine" last="Zeitouni">Karine Zeitouni</name>
<affiliation><nlm:aff id="I4">PRISM Laboratory, University of Versailles, 45 avenue des Etats-Unis, 78035 Versailles Cedex, France</nlm:aff>
</affiliation>
</author>
</analytic>
<series><title level="j">International Journal of Telemedicine and Applications</title>
<idno type="ISSN">1687-6415</idno>
<idno type="eISSN">1687-6423</idno>
<imprint><date when="2008">2008</date>
</imprint>
</series>
</biblStruct>
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<front><div type="abstract" xml:lang="en"><p>Electronic health record (EHR) projects have been launched in most developed countries to increase the quality of healthcare while decreasing its cost. The benefits provided by centralizing the healthcare information in database systems are unquestionable in terms of information quality, availability, and protection against failure. Yet, patients are reluctant to give to a distant server the control over highly sensitive data (e.g., data revealing a severe or shameful disease). This paper capitalizes on a new hardware portable device, associating the security of a smart card to the storage capacity of a USB key, to give back to the patient the control over his medical data. This paper shows how this device can complement a traditional EHR server to (1) protect and share highly sensitive data among trusted parties and (2) provide a seamless access to the data even in disconnected mode. The proposed architecture is experimented in the context of a medicosocial network providing medical care and social services at home for elderly people.</p>
</div>
</front>
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</TEI>
<pmc article-type="research-article" xml:lang="EN"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Int J Telemed Appl</journal-id>
<journal-id journal-id-type="publisher-id">IJTA</journal-id>
<journal-title>International Journal of Telemedicine and Applications</journal-title>
<issn pub-type="ppub">1687-6415</issn>
<issn pub-type="epub">1687-6423</issn>
<publisher><publisher-name>Hindawi Publishing Corporation</publisher-name>
</publisher>
</journal-meta>
<article-meta><article-id pub-id-type="pmid">18615200</article-id>
<article-id pub-id-type="pmc">2443680</article-id>
<article-id pub-id-type="doi">10.1155/2008/763534</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject>
</subj-group>
</article-categories>
<title-group><article-title>A Tamper-Resistant and Portable Healthcare Folder</article-title>
</title-group>
<contrib-group><contrib contrib-type="author"><name><surname>Anciaux</surname>
<given-names>Nicolas</given-names>
</name>
<xref ref-type="aff" rid="I1"><sup>1</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Berthelot</surname>
<given-names>Morgane</given-names>
</name>
<xref ref-type="aff" rid="I2"><sup>2</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Braconnier</surname>
<given-names>Laurent</given-names>
</name>
<xref ref-type="aff" rid="I3"><sup>3</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Bouganim</surname>
<given-names>Luc</given-names>
</name>
<xref ref-type="aff" rid="I1"><sup>1</sup>
</xref>
<xref ref-type="corresp" rid="cor1">*</xref>
</contrib>
<contrib contrib-type="author"><name><surname>De la Blache</surname>
<given-names>Martine</given-names>
</name>
<xref ref-type="aff" rid="I3"><sup>3</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Gardarin</surname>
<given-names>Georges</given-names>
</name>
<xref ref-type="aff" rid="I4"><sup>4</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Kesmarszky</surname>
<given-names>Philippe</given-names>
</name>
<xref ref-type="aff" rid="I5"><sup>5</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Lartigue</surname>
<given-names>Sophie</given-names>
</name>
<xref ref-type="aff" rid="I6"><sup>6</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Navarre</surname>
<given-names>Jean-François</given-names>
</name>
<xref ref-type="aff" rid="I3"><sup>3</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Pucheral</surname>
<given-names>Philippe</given-names>
</name>
<xref ref-type="aff" rid="I1"><sup>1, 4</sup>
</xref>
<xref ref-type="aff" rid="I4"></xref>
</contrib>
<contrib contrib-type="author"><name><surname>Vandewalle</surname>
<given-names>Jean-Jacques</given-names>
</name>
<xref ref-type="aff" rid="I7"><sup>7</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Zeitouni</surname>
<given-names>Karine</given-names>
</name>
<xref ref-type="aff" rid="I4"><sup>4</sup>
</xref>
</contrib>
</contrib-group>
<aff id="I1"><sup>1</sup>
Institut National de Recherche en Informatique et en Automatique (INRIA), Rocquencourt, 78153 Le Chesnay Cedex, France</aff>
<aff id="I2"><sup>2</sup>
SANTEOS SA, Tour Manhattan, 5,6 Place de l'Iris, 92926 Paris la Défense Cedex, France</aff>
<aff id="I3"><sup>3</sup>
Conseil Général des Yvelines, Hôtel du Département, 2 Place André Mignot, 78012 Versailles Cedex, France</aff>
<aff id="I4"><sup>4</sup>
PRISM Laboratory, University of Versailles, 45 avenue des Etats-Unis, 78035 Versailles Cedex, France</aff>
<aff id="I5"><sup>5</sup>
Association Locale de Développement Sanitaire (ALDS ), 25 avenue des Aulnes, 78250 Meulan, France</aff>
<aff id="I6"><sup>6</sup>
Coordination Gérontologique Intercommunale du Territoire Est Yvelines (CoGITEY), 6 avenue du Maréchal Franchet d'Esperey, 78004 Versailles, France</aff>
<aff id="I7"><sup>7</sup>
Gemalto, 6 rue de la Verrerie, 92190 Meudon, France</aff>
<author-notes><corresp id="cor1">*Luc Bouganim: <email>luc.bouganim@inria.fr</email>
</corresp>
<fn fn-type="other"><p>Recommended by Frédérique Laforest</p>
</fn>
</author-notes>
<pub-date pub-type="ppub"><year>2008</year>
</pub-date>
<pub-date pub-type="epub"><day>6</day>
<month>7</month>
<year>2008</year>
</pub-date>
<volume>2008</volume>
<elocation-id>763534</elocation-id>
<history><date date-type="received"><day>1</day>
<month>10</month>
<year>2007</year>
</date>
<date date-type="rev-recd"><day>21</day>
<month>3</month>
<year>2008</year>
</date>
<date date-type="accepted"><day>27</day>
<month>5</month>
<year>2008</year>
</date>
</history>
<permissions><copyright-statement>Copyright © 2008 Nicolas Anciaux et al.</copyright-statement>
<copyright-year>2008</copyright-year>
<license license-type="open-access"><p>This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</p>
</license>
</permissions>
<abstract><p>Electronic health record (EHR) projects have been launched in most developed countries to increase the quality of healthcare while decreasing its cost. The benefits provided by centralizing the healthcare information in database systems are unquestionable in terms of information quality, availability, and protection against failure. Yet, patients are reluctant to give to a distant server the control over highly sensitive data (e.g., data revealing a severe or shameful disease). This paper capitalizes on a new hardware portable device, associating the security of a smart card to the storage capacity of a USB key, to give back to the patient the control over his medical data. This paper shows how this device can complement a traditional EHR server to (1) protect and share highly sensitive data among trusted parties and (2) provide a seamless access to the data even in disconnected mode. The proposed architecture is experimented in the context of a medicosocial network providing medical care and social services at home for elderly people.</p>
</abstract>
</article-meta>
</front>
<body><sec sec-type="section" id="sec1"><title>1. INTRODUCTION</title>
<p>Since the early days of medicine,
and before the advent of computers, people have managed healthcare data
manually, accumulating drug prescriptions, examination results, and other
medical documents, all of which were inscribed on paper and stored in physical
folders at home or at the family doctor office. Although archaic by today's
standards, this manual information sharing scheme provided the data owner
(i.e., the patient) with control over the sharing and usage of his or her
information with the advised assistance of his family doctor and under the
protection of the Hippocratic Oath. The patient control was not compromized by
the digitization of medical documents in a first stage, simply because the
information was scattered among several incompatible information systems in
hospitals, clinics, and practitioner's offices. No one knows where the
information is, how to access it, whether it is complete and accurate, and
under which format it has been produced.</p>
<p>During the last decade, several countries
launched ambitious electronic healthcare record (EHR) programs with the
objective to increase the quality of healthcare while decreasing its cost [<xref ref-type="bibr" rid="B1">1</xref>
]. For example, the
national <italic>Connecting for Health</italic>
(<ext-link ext-link-type="uri" xlink:href="http://www.connectingforhealth.nhs.uk">http://www.connectingforhealth.nhs.uk</ext-link>
) program
in the UK, the <italic>National Switch Point</italic>
(<ext-link ext-link-type="uri" xlink:href="https://www.nictiz.nl">https://www.nictiz.nl</ext-link>
) managed by Nictiz in the Netherlands, or the healthcare system <italic>Infoway</italic>
(<ext-link ext-link-type="uri" xlink:href="http://www.
infoway-inforoute.ca/en/home/home.aspx">http://www.
infoway-inforoute.ca/en/home/home.aspx</ext-link>
) in Canada are all running projects aiming at building a wide scale EHR. In a recent report [<xref ref-type="bibr" rid="B2">2</xref>
], French Deputy
J.-P. Door identified more than 100 EHR running projects worldwide at the scale
of a country or region in a recent report. The objective of centralizing medical information in
database systems is manifold (centralization refers
to the fact that the data is stored, organized, made available, and controlled by database servers, whatever the computer system infrastructure is):
<italic>completeness</italic>
(i.e., to make the information complete and up to date), <italic>availability</italic>
(to make it accessible through the internet 24 hours/7 days a week), <italic>usability</italic>
(to organize
the data and make it easily queryable and interpretable), <italic>consistency</italic>
(to guarantee integrity constraints and enforce atomicity
and isolation of updates), <italic>durability</italic>
(to protect the data against failure), and <italic>security</italic>
(to protect the data against illegal accesses).</p>
<p>On the other hand, studies in
different countries [<xref ref-type="bibr" rid="B3">3</xref>
, <xref ref-type="bibr" rid="B4">4</xref>
], show that several patients and even
practitioners are reluctant to use EHR systems arguing increasing threats on
individual privacy. This
suspicion is fuelled by computer security surveys pointing out the vulnerability
of database management systems (DBMSs) against external and internal attacks [<xref ref-type="bibr" rid="B5">5</xref>
]. Indeed, centralizing
and organizing the information make it more valuable, thereby motivating
attacks, and facilitates abusive usages. In consequence, EHR
providers must comply with very stringent legislation regarding the storage and
preservation of medical data. Regardless of the security procedures put in
place at the server and their effectiveness, the patient has the sense of losing
control over his or her data. There
are four main reasons for that.</p>
<p><list list-type="roman-lower"><list-item><p><italic>Guidance of the patient consent</italic>
: the patient is usually asked to give his consent to an access control policy specifying who (individuals or
roles) is granted access to which part of his folder. Even with the help of a
practitioner, it is difficult to ensure that this consent is fully enlightened.
This is due to the high number of people interacting with the folder, the
diversity of their roles, the complexity of the medical information, and the
intrinsic difficulty to determine which data (or data association) reveals a
given pathology. Consequently, the patient usually adheres to a predefined
access control policy that he does not really master. Complementary to access control,
audit trails can help the patient tracking a posteriori who accessed
which part of his folder and when. However, audit trails exploitation is fairly
complex and may require a dedicated query language [<xref ref-type="bibr" rid="B6">6</xref>
]. With respect to the free expression
of the patient consent, EHR systems cannot compete with the archaic manual information
sharing scheme.</p>
</list-item>
<list-item><p><italic>Unbounded data retention</italic>
: limited data retention is one of the central principles of
laws related to the safeguard of personal data [<xref ref-type="bibr" rid="B7">7</xref>
]. Limited data
retention attaches a lifetime to a data (e.g., 10 years for a given court
sentence) after which it must be withdrawn from the system [<xref ref-type="bibr" rid="B8">8</xref>
]. Unfortunately, limited
data retention conflicts with the primary objective of an EHR, that is building
a complete medical history of each patient. In addition, [<xref ref-type="bibr" rid="B9">9</xref>
] highlighted the difficulty to physically
destroy information stored in existing DBMSs, showing that it can be recovered
by a forensic analysis in many ways. This reinforces the patient's perception that
his complete history is recorded forever. A side effect is that the patient may
choose not to store some information in his folder (synonym of incompleteness
and lower quality of healthcare) because he cannot assess a priori the
sensitiveness of this information.</p>
</list-item>
<list-item><p><italic>No
security guarantee outside the server domain</italic>
: healthcare data is likely to
be extracted from the server and hosted in a client device (e.g., the doctor's or
the patient's device). Typically, healthcare folders need to be extracted for
use in a disconnected mode, for example, to provide healthcare at home. This
situation will remain the rule for a while, that is until every point of the
territory be connected through a secure, fast, reliable, and free of charge
network. Unfortunately, the hosting device is much more spyware, trojan, and
virus prone than the server, introducing an important security breach in the
architecture.</p>
</list-item>
<list-item><p><italic>No
disconnected access to the folder:</italic>
EHR has been designed with online usage in mind.
This may constitute a real barrier for a large category of patients (e.g.,
elderly, disabled, and needy people), the prerequisite to get access to their folder
being either to use a terminal at some public place or to own a PC, to master
its use (including the computer administration burden) and to pay for an
internet connection. If these latter conditions are not satisfied, a practitioner
providing healthcare at home will have to download on his mobile device the
folders of all visited patients, a complex and time-consuming task, beside the
security breach mentioned above.</p>
</list-item>
</list>
</p>
<p>In
this paper, we propose a novel organization of EHR aiming at circumventing these
four drawbacks. This organization capitalizes on a new hardware device called <italic>secure portable token</italic>
(<italic>SPT</italic>
). Roughly speaking, an SPT combines
a secure microcontroller (similar to a smart card chip) with a large external flash
memory (gigabyte sized) on a USB key form factor [<xref ref-type="bibr" rid="B10">10</xref>
, <xref ref-type="bibr" rid="B11">11</xref>
]. An SPT can host
onboard data and run onboard code with proven security properties thanks to its
tamper-resistant hardware and a certified operating system [<xref ref-type="bibr" rid="B11">11</xref>
]. Embedding a database
system and a web server in an SPT gives the opportunity to manage a healthcare
folder (or a part of it) outside the EHR server with no loss of security. Accessing
the onboard folder while being disconnected from the network requires a simple rendering
device equipped with a USB port and running a web browser. More, the embedded
DBMS can be made self-administered so that the patient keeps a full control
over the onboard data, with no external intervention of a database
administrator. The data retention period and the sharing of onboard data can be
organized similarly to the previous manual scheme, under the patient control. The
resulting architecture is decentralized, with a central server managed by a
public or private database service provider and one embedded local server per
patient. Splitting the folder in a centralized part and a local part remains
under the patient's responsibility. However, the local server cannot provide
properties like availability and durability on the local data on its own. We
will show that combining the capacities of the central server and the local
servers restores these fundamental properties.</p>
<p>Our project is not the first to
promote the use of secure tokens. A growing number of initiatives are using
smart cards (e.g., the French <italic>Sesam Vitale</italic>
[<xref ref-type="bibr" rid="B12">12</xref>
], the <italic>Patient
Health Smart Card</italic>
in New York [<xref ref-type="bibr" rid="B13">13</xref>
], the <italic>National
Health Card System,</italic>
(24 millions of smart cards, see
<ext-link ext-link-type="uri" xlink:href="http://www.gi-de.com/portal/page?_pageid=42,55000&_dad=portal&_schema=PORTAL">http://www.gi-de.com/portal/page?_pageid=42,55000&_dad=portal&_schema=PORTAL</ext-link>
.), in Taiwan, etc.) to carry patient's national
security number and practitioner's certificate in order to implement a strong
identification process. Also, the German EHR initiative plans to use smart cards
to carry recent prescription information [<xref ref-type="bibr" rid="B14">14</xref>
]. As our project,
the German initiative underlines the interest of holding part of the patient's folder
locally. However, this project uses a traditional smart card technology thereby
proscribing storing a significant volume of patient's records locally (the
smart card is endowed with less than 100 KB of stable memory, (Wiki
in German: <ext-link ext-link-type="uri" xlink:href="http://www.de.wikipedia.org/wiki/
Elektronische_Gesundheitskarte">http://www.de.wikipedia.org/wiki/
Elektronische_Gesundheitskarte</ext-link>
), versus 256 MB for the preliminary
SPT we are currently working on). To the best of our knowledge, our project is
the first to tackle the technical challenges related to the management
(storage, querying, and secure sharing) of large folders embedded in secure
token.</p>
<p>The
paper is organized as follows. <xref ref-type="sec" rid="sec2">Section 2</xref>
introduces the functional architecture
of the proposed EHR system and discusses different scenarios, showing the
benefit of combining a central EHR server with secure portable folders. <xref ref-type="sec" rid="sec3">Section 3</xref>
sketches important
technical challenges and outlines the solutions proposed. <xref ref-type="sec" rid="sec4">Section 4</xref>
describes
an application of our solution to a medical network providing healthcare at
home and <xref ref-type="sec" rid="sec5">Section 5</xref>
concludes.</p>
</sec>
<sec sec-type="section" id="sec2"><title>2. FUNCTIONAL ARCHITECTURE AND SCENARIOS</title>
<p>The proposed EHR architecture, pictured in <xref ref-type="fig" rid="fig1">Figure 1</xref>
, is built around a
central DBMS server providing the functionalities mentioned above (completeness, availability, usability,
consistency, durability, and security) on all patient's folders. This server
offers an internet access to all authorized users (e.g., doctors, nurses, etc.)
and enforces access control policies defined by the patients. These policies are
based on default policies promoted by EHR groups like the GIP DMP (the GIP DMP is in charge of
setting up the French medical folder project called DMP (dossier médical personnel). See <ext-link ext-link-type="uri" xlink:href="http://www.d-m-p.org/docs/EnglishVersionDMP.pdf">http://www.d-m-p.org/docs/EnglishVersionDMP.pdf</ext-link>
and <ext-link ext-link-type="uri" xlink:href="http://www.d-m-p.org/">http://www.d-m-p.org/</ext-link>
) and can be refined with the help of practitioners.
To allow disconnected accesses to any patient folder, a folder replica is
managed on a secure portable token (SPT) provided to each patient. Once endowed
with the appropriate embedded software (typically a web server and a DBMS) and timely
synchronized with the central server, SPT servers successfully to surrogate the central server.
The access control policy defined by the patient is enforced uniformly
on the central DBMS and on the SPT. Note that the synchronization between central and SPT servers must
occur in all situations (e.g., even if an SPT remains at patient's home and is
never connected to the network). We detail this synchronization process later.</p>
<p>SPT is the means by which a patient
can recover a full control over his folder, similarly to the manual sharing
scheme. Let us assume that
a patient is
willing to hide information he judges as highly sensitive (e.g., because it may
reveal a serious or shameful disease). In a traditional EHR system, if the
patient does not fully trust the server or does not fully understand the access
control policy (for the reasons mentioned above), he has no other choice than
discarding this information, thereby producing an incomplete folder. Here, the
patient can store this information, called <italic>hidden
data</italic>
(<italic>HD</italic>
), locally on his SPT
without replicating it on the central server. A data which is not hidden is
called <italic>regular data</italic>
(<italic>RD</italic>
) and is replicated on the SPT and the
central server. If the patient changes his mind afterwards (e.g., following the
advice of his doctor), he still has the opportunity to change the status of a
data from hidden to regular. Note
that the reverse conversion (from regular to hidden) is uncertain since the
data could have been queried and/or copied beforehand. Hiding data
matches the privacy objective but the durability property is lost for this data
since a portable token is by nature not durable (it might be lost or
destroyed). Durability can be restored by using the central server as a
repository for cryptoprotected data (i.e., encrypted and signed). To this end,
hidden data is encrypted by the patient's SPT and stored encrypted on the
central server but the encryption keys are never revealed to the central
server. (Note that
encryption techniques are sometimes used by central servers to protect the
database footprint [<xref ref-type="bibr" rid="B15">15</xref>
]. With such
server-based encryption solutions, data is encrypted and decrypted on the fly
by the DBMS. Server-based encryption is thus orthogonal to the SPT-based
encryption applied to hidden data). Encryption keys stay under the SPT
control and make themselves
durable thanks to a trusted depositary. The central server guarantees the durability
and availability of hidden data without being able to interpret its content.</p>
<p>Let us now assume that the patient is
willing to share hidden data among a restricted <italic>trusted circle</italic>
of persons. The patient can define appropriate
access control rules on this data so that it becomes accessible to these people
in the presence of the patient and of his SPT (as in a paper-based scheme). The
SPT allows an even smarter way of exchanging sensitive information. The patient
may grant a trusted circle of participants to access his hidden data even if it is not together at the
same physical place. This may be helpful in case of emergency or if a remote
diagnosis is required. This can be implemented by sharing the encryption keys
of the hidden data among the SPTs of people participating in the same trusted
circle so that only these SPTs are able
to free the hidden data from its cryptoprotection. Note that those
keys are never externalized from the SPT, thus allowing enforcing access
control rules locally (those rules are stored encrypted along with the hidden
data on the central server). To distinguish them in <xref ref-type="fig" rid="fig1">Figure 1</xref>
, regular (resp.,
hidden) data and its
related access control rules are pictured in white (resp., grey). As mentioned
above, the access control policy defined by a patient must be enforced
uniformly on the central DBMS and on the SPT, independently of the status of
the data. With
hidden data, the access
control policy is strengthened by the obligation of physically sharing the
encryption keys, and this sharing is totally under the patient control. Once
decrypted, hidden data is still protected by the access control policy enforced
by the SPT.</p>
<p>Let us illustrate the behavior of
the system through a scenario involving three participants: an elderly patient named
Bob, his family doctor Jim, and a nurse Lucy. Every participant owns an SPT. Several
medical examinations are prescribed to Bob who designates a subset of them as hidden
(the others being considered as regular). The medical lab performing the examination
pushes the results on the central server. Results corresponding to hidden data are
cryptoprotected using Bob's public key before being pushed. (Bob's
public key is delivered by a PKI server while Bob's private key is replicated
on every SPT belonging to Bob's trusted circle. The management of private keys
is under the control of the secure chip and even the SPT holder cannot
interfere or tamper it. For the sake of conciseness, we do not detail further
the key exchange protocol among SPT. For efficiency,
asymmetric encryption is used only to encrypt symmetric keys used to protect
the hidden data).</p>
<p>Lucy frequently visits Bob at home.
Bob has no internet connection and seldom leaves home. Thus, Lucy acts as a
synchronization means for Bob's folder (as any other person visiting Bob and
owning an SPT). Before the visit, Lucy downloads from the central server only
the latest updates, either hidden or regular, performed in Bob's folder. This
includes the recent examination results. During the visit, Lucy's and Bob's SPTs
are synchronized. The latest updates from the central server are integrated in
Bob's local folder. Conversely, the latest updates performed in Bob's local
folder, if any, are loaded on Lucy's SPT. This allows refreshing the central
server replica the next time Lucy will connect to the server. Synchronized data
is only delivered to the recipient (i.e., central server or patient's SPT)
using a secure protocol (authentication and encryption). Lucy cannot get access
to this data, protected by the tamper resistance of the SPT.</p>
<p>Jim participates in Bob's trusted circle.
At his office, he can connect to the central server and view Bob's up-to-date folder,
including the results of the recent examinations and possible updates carried back
by Lucy (in the limit of Jim's access rights granted by Bob). When visiting Bob
at home, Jim can get the same level of information by connecting locally to Bob's SPT.</p>
<p>To summarize, any authorized people
(or people playing an authorized role) can connect to the central server or to
an SPT local server and retrieve the regular data he is granted access to by
the access control policy. No people outside the trusted circle can get access
to the hidden data, whatever their role(s) and privilege(s). Indeed, this hidden data is
cryptoprotected on the central server and the encryption keys are only known by
the patient's SPT and by the SPTs of people belonging to her trusted circle. Hidden
data stored on the patient's SPT benefits from the SPT's tamper resistance.
Encryption keys (symmetric and private keys) are transmitted from the patient's
SPT to the SPTs of the trusted circle using a secure protocol (based on symmetric
encryption). This transmission may happen either in a connected mode or via
another SPT as part of the synchronization described above. Finally,
synchronized data (regular, hidden, or encryption keys) is never disclosed to
anyone except the recipient and is also protected during transmission by a
secure protocol.</p>
<p> This mode of operation provides
stronger privacy preservation guarantees than any traditional EHR. First, attacks
conducted at the server can only reveal regular data, hidden data being absent
from the server or encrypted with keys that are let under the control of the clients'
SPTs. Most advanced server-based security solutions, even those using encryption [<xref ref-type="bibr" rid="B15">15</xref>
], cannot offer
such a level of protection because encryption keys remain accessible at the
server side to enable query execution. Second, attacks conducted at the client terminal
cannot reveal more than the data displayed by the application at runtime, but
no data is ever stored on client terminals in the clear. Third, the SPT
inherits its security from a tamper-resistant hardware and a certified embedded
code (certified CC EAL4 or 5, FIPS or using other relevant scheme [<xref ref-type="bibr" rid="B11">11</xref>
]). We do not
argue that SPT is provably unbreakable because ultimate security does not exist
but it makes the attacks so complex and costly to implement as they become
meaningless in practice. To make the analysis complete, let us consider anyway
the impact of an SPT attack. Breaking a patient's SPT will lead to disclose her
medical folder stored locally (hidden and regular data); breaking a doctor's
SPT will lead to disclose the encryption keys of the patients having registered
this doctor in their trusted circle; finally, breaking an SPT serving for
synchronization (typically a nurse's SPT) will not disclose any information.</p>
</sec>
<sec sec-type="section" id="sec3"><title>3. TECHNICAL CHALLENGES</title>
<p>Many technical challenges are introduced by the proposed EHR architecture,
like the access control definition and enforcement, the management of encryption
keys, the data synchronization between the central server and the embedded
local servers, and so forth. Due to space limitation, this section focuses on
the challenges related to the SPT and the embedded data management techniques
which are central to the architecture.</p>
<sec sec-type="subsection" id="subsec3.1"><title>3.1. SPT hardware and operating system</title>
<p> An SPT aims at combining in the
same hardware platform a secure chip and a mass storage NAND flash memory
(several gigabytes soon). The secure chip is of the smart card type, with a 32 bit RISC CPU clocked at about 50 MHz, memory modules composed of ROM, tens of
KB of static RAM, a small quantity of internal stable storage (NOR flash) and
security modules. A first obvious challenge is to produce this hardware platform
and assess its tamper resistance and performance. In this platform, the mass
storage NAND flash memory is outside the secure chip (connected by a bus) and
does not benefit from the chip hardware protection. A second challenge is then to
enforce the integrity and the confidentiality of the data stored in mass
storage thanks to the cryptographic capability of the secure chip, with a
minimal impact on read/write performance. Considering the increasing storage
capacity, computation power and communication throughput of this new generation
of smart tokens, integrating them in a distributed architecture as regular
computers is a third challenge.</p>
<p>Gemalto, the smart card world
leader, is developing an experimental SPT platform. This platform includes a
new multitasking operating system allowing the development of web applications
based on Java and Servlet technology, and thus offering a standardized means to
integrate services or embedded web applications to the SPT. The operating
system supports natively:</p>
<p><list list-type="roman-lower"><list-item><p>the USB 2.0 protocol and the internet
protocol IP for communicating with the external world [<xref ref-type="bibr" rid="B16">16</xref>
];</p>
</list-item>
<list-item><p>multithreaded Java applications;</p>
</list-item>
<list-item><p>cryptographic primitives (some of which being implemented in hardware);</p>
</list-item>
<list-item><p>memory management and garbage collection;</p>
</list-item>
<list-item><p>servlet management and web server.</p>
</list-item>
</list>
</p>
<p>The internal architecture of the
SPT in described in
<xref ref-type="fig" rid="fig2">Figure 2</xref>
. For more technical details, we refer the reader to [<xref ref-type="bibr" rid="B17">17</xref>
].</p>
</sec>
<sec sec-type="subsection" id="subsec3.2"><title>3.2. Embedded database system</title>
<p>DBMS designers have produced light versions of their systems for
personal assistants (e.g., Oracle-lite, DB2 everyplace, SQL Server for Window
CE) but they never addressed the more complex problem of embedding a DBMS in a
chip. Initial attempts toward a smart card DBMS were ISOL's SQL Java machine [<xref ref-type="bibr" rid="B18">18</xref>
], the ISO
standard SCQL [<xref ref-type="bibr" rid="B19">19</xref>
], and the
MasterCard Open Data Storage [<xref ref-type="bibr" rid="B20">20</xref>
]. All these
proposals concerned traditional smart cards with few resources and therefore
proposed basic data management functionalities (close to sequential files).
Managing embedded medical folders requires much more powerful storage,
indexation, access control, and query capabilities. PicoDBMS was the first full-fledged
relational DBMS embedded in a smart card [<xref ref-type="bibr" rid="B21">21</xref>
] and was implemented on top of Gemalto's smart
card prototypes [<xref ref-type="bibr" rid="B22">22</xref>
]. The
peculiarities of secure chip environments compel to deeply revisit existing
DBMS techniques like storage and indexing models, query execution strategies
and transaction management. PicoDBMS has been designed for managing databases
stored in a (megabyte sized) EEPROM stable memory integrated in the secure chip
and protected by the chip tamper resistance.</p>
<p>The SPT framework introduces
important new challenges [<xref ref-type="bibr" rid="B23">23</xref>
].</p>
<p><list list-type="order"><list-item><p>How to support complex access rights and
queries over a gigabyte-sized onboard database (compared to PicoDBMS, the
database size grows by three orders of magnitude while the RAM resource was multiplied
roughly by 5)?</p>
</list-item>
<list-item><p>How to organize the data storage and the
indexes with an acceptable insert/update time considering the peculiarities of
NAND flash memory (fast reads, costly writes, block-erase-before-page-rewrite
constraint)?</p>
</list-item>
<list-item><p>How to protect the onboard database
against confidentiality and integrity attacks without degrading the query
performance; this challenge is related to the flash protection problem
mentioned in <xref ref-type="sec" rid="subsec3.1">Section 3.1</xref>
but solutions specific to database management can be
devised to provide optimal performance?</p>
</list-item>
</list>
</p>
<p><xref ref-type="fig" rid="fig3">Figure 3</xref>
depicts the main software
modules of the embedded DBMS, tagged with numbers indicating the related technical
challenge.</p>
<p>The <italic>Query Manager</italic>
is in charge of parsing the incoming SQL query,
building an optimal query execution plan, and executing it. This module must
consider peculiar execution strategies to answer complex SQL queries over a
large quantity of data (gigabytes) while coping with the SPT hardware constraints
(challenge 1). To tackle this challenge, we designed a massive indexing scheme presented in [<xref ref-type="bibr" rid="B24">24</xref>
], which allows processing complex queries while consuming as little RAM as
possible and still exhibiting
acceptable performances. The idea is to combine in the same indexing model
generalized join indices and multitable selection indices in such a way that
any combination of selection and join predicates can be evaluated by set
operations over lists of sorted tuple identifiers. The operator library
(algorithms for the operators of the relational algebra, e.g., select, project,
join, and aggregate) and the execution engine integrate those techniques.</p>
<p>The <italic>Storage Manager</italic>
, on which the query manager relies to access the
database content (index and tables), is directly concerned with challenge 2.
Indeed, the proposed massive
indexation scheme causes a difficult problem in terms of flash updates, due to
the severe read/write constraints of NAND flash. Therefore, we designed
a structure which manages data and index keys sequentially so that the number of rewrites in flash
is minimized. The use of summarization structures (based on bloom filters [<xref ref-type="bibr" rid="B25">25</xref>
]) and vertical
partitioning reduce the cost of index lookups. These additional structures are
also managed in sequence. A first implementation of this principle has been
patented jointly by INRIA and Gemalto [<xref ref-type="bibr" rid="B26">26</xref>
] and is integrated in the current DBMS
prototype.</p>
<p>The <italic>Hardware Manager</italic>
embeds
the methods for accessing the different memory modules of the SPT (through the
Flash Translation Layer (FTL) [<xref ref-type="bibr" rid="B27">27</xref>
] or with direct access). It includes techniques
associated with challenge 3, to protect the confidentiality and the integrity
of the data, in an efficient way with respect to DBMS access patterns. Indeed, our
massive indexation technique leads to numerous, random, and fine grain accesses
to raw data. We conducted preliminary studies [<xref ref-type="bibr" rid="B28">28</xref>
], in which we combine
encryption, hashing, and timestamping techniques with query execution techniques in order to satisfy three conflicting
objectives: efficiency, high security, and compliance with the chip hardware
resources.</p>
<p>Finally, the <italic>Metadata Manager</italic>
manages the DBMS metadata, the access
control rules regulating the access to regular and hidden data and the encryption keys.</p>
</sec>
</sec>
<sec sec-type="section" id="sec4"><title>4. EXPERIMENTAL PLATFORM</title>
<sec sec-type="subsection" id="subsec4.1"><title>4.1. Experiment in the field</title>
<p>The functional architecture presented in <xref ref-type="sec" rid="sec2">Section 2</xref>
will be experimented
in the context of a medicosocial network providing medical care and social
services at home for elderly people in the Yvelines district, France. Today,
the coordination among the participants of this network (doctors, nurses,
physiotherapists, social workers, etc.) is organized around a paper-based
folder. This folder stays at home and is queried and updated by every
participant. This solution suffers from two main drawbacks. First, instead of
providing a natural and controlled way of sharing medical and social
information, the paper-based folder is the primary source of confidentiality
breach in this setting. Indeed, this folder must be shared by all participants
but there is no means by which an effective access control policy can be
implemented. Second, the folder cannot be accessed and filled remotely,
precluding remote diagnosis, and is often incomplete due to its physical
centralization. Replacing this paper-based folder system by a traditional EHR
would introduce the drawbacks mentioned in <xref ref-type="sec" rid="sec1">Section 1</xref>
. The proposed
experimentation will combine a central database with medicosocial folders
embedded in SPT, according to the architecture presented in the previous
section.</p>
<p>This experimentation will be conducted with a population of about 100
volunteer patients and 25 practitioners and social workers in the Yvelines
district in France.
It involves the following partners: the French National Research Institute in
Computer Sciences (INRIA), University of Versailles, SANTEOS
(EHR provider for the prefiguration phase of the French national healthcare folder
system), Gemalto (world leader in the smart card domain), ALDS (a home healthcare
association), and CoGITEY (a clinic with a section dedicated to elderly
people). This project is partly funded by the Yvelines district council and by
the French National Agency for Research (ANR). The design phase started in
January 2007 and the experimentation in the field will be conducted fall 2009.</p>
</sec>
<sec sec-type="subsection" id="subsec4.2"><title>4.2. Software platform</title>
<p>In the experiment, the final user (either practitioner or patient) will
be able to connect to a server (either central or embedded) with a web browser
running on any terminal (fixed or mobile). A web-based interface (GUI) is
provided to browse the patient folder. By manipulating the GUI, the user
generates HTTP requests to the server, thereby activating Servlets which in
turn generate database queries and build the next page of the interface. Whatever
the server it is connected to, the GUI provides similar functions, for example,
access to patients' folders, authorization management, and so forth. The software
platform enabling this behavior is presented in <xref ref-type="fig" rid="fig4">Figure 4</xref>
.</p>
<p>The central server is equipped with commercial software including a web
server (the GUI is generated using Servlets and JavaServer Pages), a relational
DBMS (to store, index, and retrieve patients' folders), and a server of
identities (to manage certificates and identifiers for medical and social
workers and patients).</p>
<p>The SPT embeds a proprietary web server and Servlets communicating with
a lightweight DBMS engine via a JDBC-like driver. A synchronization module is
also embedded in the SPT to synchronize the embedded folder with the copy
stored in the central server. Thus, the software deployed on the central server
and the SPT provide
similar functionalities while relying on highly different technology to cope
with the SPT hardware constraints. For more information about the software
platform, we refer the reader to [<xref ref-type="bibr" rid="B17">17</xref>
].</p>
</sec>
</sec>
<sec sec-type="section" id="sec5"><title>5. CONCLUSION</title>
<p>In this paper, we presented an
alternative to centralized EHR systems, relying on a new hardware portable
device called <italic>secure portable token</italic>
(<italic>SPT</italic>
). This
architecture is being implemented in the scope of the DMSP and PlugDB projects
started in November 2006 and will be experimented in the fall of 2009 in the context of a medical social network providing medical care and
social services at home for elderly people.</p>
<p>The objectives pursued are</p>
<p><list list-type="roman-lower"><list-item><p>to build a
shared medicosocial folder providing the highest degree of availability,
whatever the mode of operation (disconnected or not);</p>
</list-item>
<list-item><p>to reestablish
a natural and powerful way of protecting and sharing highly sensitive
information among trusted parties.</p>
</list-item>
</list>
</p>
<p>The expected outcome of this project is to demonstrate that these two
objectives can be reached with a positive impact on the coordination of medical
and social workers and on the acceptation of patients of an electronic usage of
their medical history.</p>
</sec>
</body>
<back><ack><title>ACKNOWLEDGMENTS</title>
<p>This work is partially funded by the French National Agency for Research
(ANR) under the RNTL-PlugDB project and by the Yvelines district council under
the DMSP contract.</p>
</ack>
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<floats-wrap><fig id="fig1" position="float"><label>Figure 1</label>
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