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  <front>
    <journal-meta>
      <journal-title-group>
        <journal-title>October</journal-title>
      </journal-title-group>
    </journal-meta>
    <article-meta>
      <title-group>
        <article-title>Development of a HIPAA-compliant synchronizer to Enable Automatic Reporting and Inter-institutional Collaboration in Healthcare Systems Worldwide.</article-title>
      </title-group>
      <contrib-group>
        <contrib contrib-type="author">
          <string-name>Fernando Yepes-Calderon</string-name>
          <xref ref-type="aff" rid="aff1">1</xref>
        </contrib>
        <contrib contrib-type="author">
          <string-name>J. Gordon McComb</string-name>
          <xref ref-type="aff" rid="aff0">0</xref>
        </contrib>
        <aff id="aff0">
          <label>0</label>
          <institution>Children Hospital Los Angeles</institution>
          ,
          <addr-line>Los Angeles</addr-line>
          ,
          <country country="US">United States</country>
        </aff>
        <aff id="aff1">
          <label>1</label>
          <institution>Science Based Platforms LLC</institution>
          ,
          <addr-line>604 Beach CT, Florida, 34950</addr-line>
          ,
          <country country="US">USA</country>
        </aff>
      </contrib-group>
      <pub-date>
        <year>2023</year>
      </pub-date>
      <volume>2</volume>
      <fpage>6</fpage>
      <lpage>28</lpage>
      <abstract>
        <p>Having analytical capabilities inside clinics is an obeyed step forward since most diagnosing data is currently created in a format suitable to computer processing. The advantages of having the machines working on the extraction of numbers benefit all parts of the healthcare pipeline, fastening verdict generation, broadening the use of stored data, cross-correlating the multiple sources of information, and profiting from theoretically unlimited quantifications, which are the core for creating evidencebased verdicts, fast population analysis, more accurate diagnosis, enforcement of patients' adherence to treatment and interinstitutional cooperation envisaging the use of big data and artificial intelligence. Nevertheless, such a platform requires integrating several subsystems that developers still need to conceive to interact with each other. Additionally, the automation must comply with confidentiality regulations; therefore, security breaches are open while processing the data. The presented work involves the development of an architecture capable of allocating an unlimited number of algorithms inside healthcare facilities, which provides quantifications without perturbing the operation of the transport utilities that are already working. Moreover, the presented design can return numbers to a centralizer that keeps a simple yet robust protocol to assert inter-institutional cooperation around big data and artificial intelligence implementations.</p>
      </abstract>
      <kwd-group>
        <kwd>eol&gt;Artificial intelligence</kwd>
        <kwd>PACS</kwd>
        <kwd>Medical Imaging</kwd>
        <kwd>HIPAA</kwd>
        <kwd>Big Data</kwd>
      </kwd-group>
    </article-meta>
  </front>
  <body>
    <sec id="sec-1">
      <title>1. Introduction</title>
      <p>
        With the advent of artificial intelligence, the data stored in healthcare facilities suddenly gained
unexpected relevance. Hospitals, clinics, and healthcare administrators initially obeyed to save
patient records by law [
        <xref ref-type="bibr" rid="ref1">1</xref>
        ], now recognize the value of the experience inherently attached to
the data repositories since those records are precursors for machine-operated services. The
new technological platform can speed up diagnosis, enhance accuracy, and improve patient
adherence to treatment [
        <xref ref-type="bibr" rid="ref2 ref3">2, 3</xref>
        ]. Mid-term benefits encompass data centralization to constantly
monitor infectious agents, population analysis, and better budgetary programming even within
universal health care systems. The utter purpose aims to exploit the experience attained from
stored data to replace the medical practice’s costly curative and preventive methods with
prediction-based strategies [
        <xref ref-type="bibr" rid="ref4 ref5">4, 5</xref>
        ].
      </p>
      <p>
        Recent Artificial Intelligence (AI) implementations in medicine and other high-impact fields
have created an optimistic atmosphere around many possibilities that might emerge when
machines execute tasks [
        <xref ref-type="bibr" rid="ref6 ref7">6, 7</xref>
        ]. Nevertheless, integrating cognitively capable tools into existing
medical networks is challenging [
        <xref ref-type="bibr" rid="ref8">8</xref>
        ]. From a telecommunications perspective, medical data is
protected by laws and strict regulations like the Health Insurance Portability and Accountability
Act (HIPAA); therefore, technological utilities for data transport and administration – although
running over the unsecured TCP/IP protocols – have been patched to provide the required
security as in the Picture Archiving and Communication System (PACS) [
        <xref ref-type="bibr" rid="ref9">9</xref>
        ]. Up to here, having
access to databases remains a technical issue that one can solve with simple actions such as
opening a port to automation - a routine task within TCP/IP networks -. However, regulations
impose a real dificulty. The data, raw or derived from original records, should not lead to
patient identification. Recall that PACS or any other transport-specialized utility in hospitals
and clinics move DICOM formats in which each package carries confidential information in
the header [
        <xref ref-type="bibr" rid="ref10">10</xref>
        ]. Thus, any automation must deal with inherent TCP/IP security flaws, avoid
human interaction in the pipeline’s intermediate steps, and anonymize the data right after being
gathered [
        <xref ref-type="bibr" rid="ref11">11</xref>
        ]. From an operational perspective, the data must flow in virtually closed channels,
equivalent to saying that only assigned specialists and involved patients or relatives should have
access to medical records per case. In those facilities where transport software such as PACS is
in use, mistakenly moving data from one channel to another would lead to record incoherence
and general failure. Another operational challenge is the need for algorithm repositories within
hospitals and clinics. Even in the most sophisticated healthcare facilities, specialists generate
verdicts with relatively few assisting quantifications performed by certified automatic tools
[
        <xref ref-type="bibr" rid="ref12 ref13">12, 13</xref>
        ].
      </p>
      <p>
        Once these dificulties are solved, developers might want to share numbers among several
institutions, a task that requires administration and management input. Interinstitutional
integration is desirable because it spreads the usability of AI to more extensive geographical
regions [
        <xref ref-type="bibr" rid="ref14">14</xref>
        ], and generalizations in knowledge and verdicts can consider a bigger formulation
space, yet with a feature space fixed by the certified implementations.
      </p>
      <p>This manuscript presents the design and implementation of a data architecture integrating
access to standard transport managers and algorithms to share the resulting quantifications
with a data centralizer. The architecture automates the extraction of numbers that describe
pathologies’ verdicts and treatment-tracking responses inside the institutions and shares labeled
numbers with the centralizer, where a higher hierarchy implementation runs population analysis
to provide a myriad of new AI-based services to society.</p>
      <p>This document is organized as follows: the materials and methods sections present the
technicals behind the solution implemented to assert querying flexibility and, thus, enable
the capability to retrieve data from any repository. Then, we explain how the final users can
program jobs using smartphones or web interfaces by perfecting their querying interfaces and
defining the algorithms for the programmed jobs. Finally, we present the schematics for the
architecture capable of reading and executing the jobs while complying with confidentiality
regulations. The materials and methods section ends with two detailed proofs of concepts
where we produce analytics using the proposed architecture. In the results section, we display
interface prototypes of the syncing utility since those views are the highest-level component of
a solution for the problems that motivated this work. The results section also provides evidence
for the two proofs of concept listed in the materials and methods section. Finally, we discuss the
inclusion of analytics into medical pipelines and further work. In the conclusion, we concisely
resume the more striking contributions of this work.</p>
    </sec>
    <sec id="sec-2">
      <title>2. Materials and methods</title>
      <p>
        The synchronizing interface will serve as a referee by signaling the functionalities required to
provide analytics and automatic reporting inside clinics and hospitals. The proposed architecture
should comply with protocols of specific appliances and be flexible enough to keep operative
regardless of infrastructure size or running applications. Moreover, the design should consider
adding new data sources, new sharing numerical data schemes, and new reporting templates
without afecting the operation of the already established services. The syncing interface should
provide redundant security mechanisms since this device is physically visible and accessible
within hospital premises. Access to the configuration methods of this device would represent a
security breach that might render void its usability under HIPAA terms [
        <xref ref-type="bibr" rid="ref15">15</xref>
        ].
      </p>
      <sec id="sec-2-1">
        <title>2.1. Querying orders in a multi-user, multi-institution, multi-database environment</title>
        <p>
          The presented architecture allows healthcare providers to schedule data processing tasks easily.
The pipeline starts when a user’s smartphone synchronizes with the Evalu@ service (E@) [
          <xref ref-type="bibr" rid="ref16">16</xref>
          ].
The syncing happens whenever the fingerprint, face, or login/pass credentials are correctly
presented in E@’s native smartphone interfaces. Once authenticated, the user can navigate
through hospitals and query instruments. Through the forms displayed in the query instruments,
users create filtering definitions. Whenever a user fulfills a formulary and feds E@, a new data
processing order is saved in the system. The institution and data repository identifiers are saved
in variables cid and eitid. At the same time, the software builds the data filtering string with
the responses captured by the querying instrument pointed with variable eid. Within the form,
the authorized user must define the algorithm or set of algorithms to process the filtered data,
and the system will propagate that selection in the string array aid. The designed protocol
and signaling allow multiple institutions to be handled without the risk of merging orders or
forwarding results to the incorrect institution or person.
        </p>
        <p>Since the E@-Med – the local interface – initiates the communication with the E@ service,
there is no space for security breaches, and keeping the link alive with distinct institutions
remains under local control.</p>
      </sec>
      <sec id="sec-2-2">
        <title>2.2. Accessing repositories in a local domain</title>
        <p>Regardless of network security and complexity, hospitals and clinics rely upon TCP/IP for data
transport. Applications such as File Transfer Protocol (FTP), its secure version SFTP, Pop3 or
IMAP for emailing, or the specialized PACS are extensions of the platforms supporting the</p>
        <p>Institutional querying instruments</p>
        <p>Load once
Forms filling
Acq date (0008,0032)?
Acc number (0008,0050) ?
Modality (0008,0060)?
...</p>
        <p>Specfic fields for
specific repository
...</p>
        <p>Form for repository A
(cid, eitid,  eid, aid)</p>
        <p>Form for repository B
(cid, eitid, eid. aid)</p>
        <p>
          Institution B
internet. Therefore, accessing a local or remote repository can be generalized as shown in
Figure 2. In general, a user willing to retrieve data – human or robot – will need to provide
the IP address of the machine where the information resides, namely the "host," a username,
and a password. The host is an IP address or a human-readable name that will be translated to
its correspondent IP address in networks with active domain name servers (DNS); otherwise,
the IP address will be enough to activate the Address Resolution Protocol (ARP) that completes
the TCP/IP requirements to establish a communication between computers in share media. At
this moment, the syncing interface (E@+Med) will deliver the user and passwords through the
recently established channel, and, in case access is granted, the syncing interface will need to
provide the querying string that varies in extent and complexity depending on the repository
or a path inside the host in less complex transport applications [
          <xref ref-type="bibr" rid="ref17">17</xref>
          ].
        </p>
      </sec>
      <sec id="sec-2-3">
        <title>2.3. Data processing</title>
        <p>
          The aid variable holds a unique identifier for tested and approved algorithms, in which docked
executables are uploaded to E@ as in an application repository such as Android or Apple stores.
Then, E@ shares those docked codes with every registered E@-Med, making the software
solutions available to all users with accounts in at least one of the collaborating institutions.
The architecture warrants data processing inside the institutions within a protected domain.
When users define the querying string to filter data, they also select the algorithm(s) for
processing. The algorithm developer defines the deliverables of each solution, and users accept
the implementation as it is. With the querying string, the E@-Med brings the data, decrypts it,
anonymizes it, and makes it available in a temporal directory, as we presented in [
          <xref ref-type="bibr" rid="ref18">18</xref>
          ]. Then, it
calls the selected algorithms and waits for the outputs listed in a JSON file residing in the same
folder where the docked code is. The E@-Med uses the algorithm description saved as a JSON
ifle to define whether the resulting reports should be sent to the referring user by institutional
email, back to the original repository, or both. Another mandatory section of the reporting
JSON defines the API parameters and numerical variables that will be shared with the data
centralizer E@.
        </p>
      </sec>
      <sec id="sec-2-4">
        <title>2.4. Proofs of concept</title>
        <sec id="sec-2-4-1">
          <title>2.4.1. Supporting Institutional Review Board (IRB) tasks</title>
          <p>Only moving the data and making it available for research endeavors is one of the most solicited
applications. The data should be anonymized and converted to a format that is easy to transport.
The most critical case happens when DICOM data are required after screening for a specific
pathology, patient’s age, gender, or treatment. The user can also set aspects such as the number
of studies and the range of creation dates. As explained in Section 2.2, each repository defines
the fields needed to create an order. For this purpose, a user employs the string query creation
functionality to filter the data. What follows for this particular application does not need data
processing; instead, it will request an action from an IRB member, which consists in authorizing
the IRB study to be delivered to the requesting user. The system will provide emails to inform
process flagging and availability.</p>
        </sec>
        <sec id="sec-2-4-2">
          <title>2.4.2. Ventricular volume before and after Shunting</title>
          <p>One common problem in radiology and neurosurgery units is monitoring the correct operation
of installed CSF draining valves. Young hydrocephalus patients often receive an MRI before and
after surgically placing the device. The medical images are taken at diferent moments, and the
MRI technician defines imaging parameters to proceed with the critical constraint of favoring
the patient’s comfort, thus producing the images in the shortest possible time. This proof of
concept shows the results of an algorithm that reports the diferences in ventricular volumes
between studies. The Querying string is specific about grabbing FLAIR T2 images produced
in a range of rates over one patient id; therefore, the algorithm will try to segment the lateral
ventricles in all found volumes and report them with the study acquisition date. Additionally,
the final report displays a 3D reconstruction of the segmented structures with the read volumes
in mm3.</p>
        </sec>
      </sec>
    </sec>
    <sec id="sec-3">
      <title>3. Results</title>
      <sec id="sec-3-1">
        <title>3.1. Syncing interface administration</title>
        <p>The syncing interface displays eight environments to all authenticated users, except for the
super-administrator, who will see the ambient to manage users. The signing-in process includes
a tokenized key sent to the institutional email and a fingerprint reading, such as security
robustness to respond to HIPAA regulations. The interfaces shown in Figure 4 correspond to
diferent displays where the administrators control the available repositories.</p>
        <p>The add repository interface allows the administrator to define unlimited databases. There is
no fixed template to explain the connection parameters. Instead, the administrator is encouraged
to provide suficient information in the form key:value to have successful connections, and this
lfexibility also supports further changes to repositories’ security. The E@-Med interface will
use both keys and values to connect the storage as shown in Figure 2.</p>
        <p>In Figure 5, panel A shows the superficial functionality for repositories. From here, an
administrator can turn the access to algorithms on and of, and this action will be reflected
system-wide. To add an algorithm, the administrator should use the add algorithm function
(screenshot not shown).</p>
        <p>Panel B of Figure 5, presents the only screen for the exclusive use of super-administrators.
From here, the authorized user can give access to the critical functions of E@-Med to
secondlevel administrators after registering their fingerprints; therefore, someone will always be
available in the hospital’s facilities to control the system’s behavior in local environments.</p>
      </sec>
      <sec id="sec-3-2">
        <title>3.2. POC 1: Clinical data available for research purposes</title>
        <p>After the IRB has authorized the use of clinical data, the files are delivered without encryption,
anonymized, and in Nifti format. The new container concatenates the individual DICOM files
and deletes the DICOM headers; therefore, the new files occupy less space in the disk and are
easier to transport. Figure 6 displays a query run on the command line as the E@-Med would
do with the configured Cron job. The presented connection involves a PACS system, and a
video of this interaction is available at www.fernandoyepesc.com..</p>
      </sec>
      <sec id="sec-3-3">
        <title>3.3. POC 2: Ventricular volume before and after Shunting</title>
        <p>An algorithm based on the Automatic Ventricular Volume Estimator AVVE runs on MRI volumes
of the same subject. The querying string used a patient number and study creation date
constraints. Therefore, for the specific case, two volumes are compared. The Data gathering
process occurs in the same manner presented in Section 3.2. After that, the system calls the
modified version of the AVVE and provides the gathered volumes – two volumes due to the date
constraint – for processing. The system creates the report shown in Figure 7, which can be
dicomized and sent back to PACS. The processing also includes returning Evalu@ the patient’s
age in days and the ventricular volumes before and after the shunt procedure.</p>
      </sec>
    </sec>
    <sec id="sec-4">
      <title>4. Discussion</title>
      <p>
        Authors producing thousands of methods developed year by year in research units will not have
the opportunity to implement their creations in a production environment. Such a situation
precludes the use of technology to benefit many aspects of current healthcare methods. The
transport utilities inside hospitals – as specialized as PACS or simple FTP-based ones – could be
adjusted to move the data to temporal storages where algorithms perform diverse quantifications.
With such a level of Generalization, proposals such as integrating the Radiology Information
Systems (RIS) and PACS to complement the storing and data-sharing capabilities and provide
this new platform with image processing capabilities [
        <xref ref-type="bibr" rid="ref19 ref20">19, 20</xref>
        ], become a specific use of the
proposed architecture. Additionally, working on these transport applications with no view
to interinstitutional collaboration forces the proliferation of developments with few or no
probabilities of unification. Such a scheme precludes the golden opportunity of collecting tons
of data from particular abnormalities with context pertinence that artificial intelligence experts
highly appreciate.
      </p>
      <p>
        Instead, the proposed architecture covers the need for analytics in hospitals and clinics where
algorithms are used globally. The authors can test their creations in real arenas and gain prestige.
When an algorithm is valuable and infallible, healthcare institutions will use it to obtain all the
benefits that several authors have agreed on regarding the need for analytics within hospitals
[
        <xref ref-type="bibr" rid="ref21 ref22">21, 22</xref>
        ]. Moreover, the architecture envisages an App store exclusive for medical applications
that will collect data on all sorts of abnormalities to run AI and provide inter-institutional
feedback to improve the decision capabilities of worldwide health systems.
      </p>
      <p>The presented architecture integrates several communication systems and is flexible to
incorporate new repositories with cutting-edge security strategies of today and further ones. The
presented protocol assures that external communication does not propagate confidential
information and algorithm execution happens in local facilities using local resources. Additionally,
the system facilitates job programming by integrating smartphone technology.</p>
      <p>Further developments involve the creation of a testing environment where authors can check
feasibility while the platform assures the rightness of the presented codes. Also, we envisage
the creation of new algorithms and the possibility of connecting them in compounded pipelines.</p>
    </sec>
    <sec id="sec-5">
      <title>5. Conclusion</title>
      <p>The presented interface is a flexible system that enables analytics inside hospitals, respecting
HIPAA and implementing a protocol that allows interinstitutional collaboration to support
artificial intelligence implementations. Confidentiality compliance is accomplished when the
system only allows human interaction in the tasks’ programming and when receiving the
reports. Additionally, the proposed architecture gives local administrators the faculty to turn
of the components of the system at will.</p>
    </sec>
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