This document discusses preparing healthcare organizations for a digital future. It explains that electronic health records and digital health information systems can improve patient care by giving providers a comprehensive digital view of a patient's health history. However, digital transformation requires new tools to securely manage both structured data and unstructured information like medical images. The document recommends that healthcare organizations implement an enterprise content management system to collect, manage, and act as a repository for both structured and unstructured patient information across departments. This will help improve efficiency, collaboration, and regulatory compliance while reducing costs.

1. Preparing for a digital
future in healthcare
White paper
Digital health information systems help doctors and
health care providers deliver better quality care. With
electronic health records, health care providers have a
comprehensive, digital view of a patient’s health history,
improving efficiency, collaboration and safety.

2. 2/8Preparing for a digital future in healthcare
Introduction 3
Digital information requires new security tools 4
Bottom line 5
The role of ECM in meeting healthcare’s digital needs 5
Modules to prioritize in your ECM purchase 6
Solution 7
Web sources used for regulations and technical standards
for compliance management 8
Contents

3. 3/8Preparing for a digital future in healthcare
Introduction
The stages of digital readiness varies widely among healthcare organizations. While some
clinics and diagnostics companies started in the digital age and have never had paper
files, older practices may have filing cabinets overflowing with paper records. In the middle,
there are organizations that have moved new cases and much of their data to computerized
systems but still rely on paper for most of their patient interactions.
For many healthcare organizations, the digital transformation is a slower, confusing
process. They have digitized their data but their information is often still managed using
traditional tools and methods. The difference between data and information is crucial and
a nuance that many miss. Data is the structured facts and figures, the 1s and 0s that are
contained in a database. The adoption of EMR technologies has largely tamed the data
problem. Information, on the other hand, is more complex. Information in this instance
is the unstructured data, which can include a PDF, email, image or a complex file type,
such as an MRI or CT scan image and patient hand-off notes. By definition, unstructured
information does not fit nicely in a structured database, such as an EMR, and requires an
Enterprise Content Management solution.
While the EMR/EHR application will always be the central repository of patient data, there
is a clear need to house old records and patient-related documents in a digital system.
Using modern ECM, you will have a platform to both collect and manage information and
act as a repository for that content. In the figure below, you can see a repository broken
into categories that guide the user to the right piece of information. ECM also can be used
to extract information from faxes, emails and scanned documents to ensure the care
team has all the vital information no matter what source it comes from, while controlling
administrative costs.
Figure 1: OpenText™
ApplicationXtender's search-based view allows for easy search of patient
files based on document contents, as well as any extracted data from scanned documents.
This is the user view, it is simple and
focused on information the user needs
to do their job. It mirrors the terms and
types of easily scanned information
to make it easier to find items and to
help new members of the care team
understand the process. The solution
is configured to show a unique view
to each user based on their role in the
workflow. It can be easily configured
to recognize documents and apply the
metadata, ICD-10, Medicare and other
codes to enable billing, patient routing
and compliance.

4. 4/8Preparing for a digital future in healthcare
For care team members, finding patient information should be simple and not require
their full attention.
Figure 2: In many clinics, finding prescriptions, test results and notes from other patient
care team members is painful. This system eases that pain with a single search pane for
paper, electronic and faxed information.
In today’s complex care management environment, organizations are looking for tools that
can extend the usability of the EMR through simple workflow that presents information to
the right person at the right time.
Digital information requires new security tools
Across many industries, data breaches have become a hot button issue. The healthcare
sector is dealing with this in many ways, including the HIPAA information security directives.
HIPAA’s information security directives are not limited to strictly clinical data. The directives
are designed to protect patient accessibility to their own information that is held, used or
managed by a healthcare organization. This may include the patient’s billing information
or phone numbers and email addresses used to confirm appointments. This is personal
information that could be the credentials needed to access the patient portal and view
patient information.
It is also important to recognize that patient electronic documents don’t only need to be
managed for regulatory purposes. For example, the Center for Medicare and Medicaid (CMS)
is the main auditor for drug supply programs, however Health and Human Services oversees
HIPAA information security audits. This complicates internal compliance management. For
example, if you have a satellite clinic or partner who is a participant in any type of patient
prescription program (for example, Medicaid programs, clinical trials), this is auditable by
multiple regulators. These regulators may not be on your central compliance management
group’s radar, leaving a small clinic to manage these materials, possibly without the resources
to effectively control the information.
In Figure 2, the series of information
capture points looks like the forms
that doctors and nurses are used to
scanning, making it easier for them
to focus on the patient rather than
a screen. Whether team members
capture the information on a desktop
or mobile device, they will have the
same experience and data capture
capabilities. The solution also auto-
completes codes and provides tips on
drug dosing and route of administration.

5. 5/8Preparing for a digital future in healthcare
Organizations of all sizes need to move to digital. Many hospitals, especially single-site
and primary care clinics, are still in the midst of transitioning from paper to digital files.
These documents are burdensome and represent a key cost drain on the healthcare
system and reduce profitability for small clinics and hospitals. Creating a searchable
digital repository that can hold scanned documents and extract appropriate information
will greatly reduce this issue. From a regulatory perspective, the expectation is that all
of the information being moved will be handled appropriately to protect privacy while
remaining accessible to patients upon request. The key to meeting this expectation is
ensuring that your organization’s business rules are repeatable, auditable and treated as
part of a record management process.
Bottom line
HIPAA requires standardized methods for managing, transmitting and accessing any
clinically-related information. If you manage or simply have access to personally identifiable
information, including insurance numbers, medical history or drug trials, you must be
able to provide auditable processes to confirm that all access to patient information has
conformed to a standardized operating procedures that ensures its integrity.
The role of ECM in meeting healthcare’s digital needs
Controlling administrative workflows and easy data sharing with the EMR of your choice
Many healthcare organizations will still have documents and processes that simply do not
fit within the EMR system. In this case, using industry-standard software is simpler than
attempting to modify or customize your EMR to meet your business needs.
Three areas where an ECM system and a modified EMR differ are:
1. Cost of licensing. On average, a single license for an EMR system is more expensive
than a focused ECM product. The value of an EMR license is in the wide array of clinically
relevant data that it can handle. If the user is only accessing patient insurance information,
the value is not sufficient.
2. Maintaining permissions. Most healthcare organizations have a complex cross-
departmental connection of admission, transcription and billing administration that is
difficult to model in an EMR system but is relatively easy to model in a process-focused
ECM solution.
3. Cost of customization. Most EMR systems are closed and require expensive professional
services to make any changes. Furthermore, you may void upgrade paths and/or
support agreements by performing the modifications without the using vendor services.
Conversely, most ECM systems are designed to be modified by organizations and provide
software development kits and user-friendly APIs.

6. 6/8Preparing for a digital future in healthcare
Choosing ECM products to create an aligned system
In a perfect world, ECM solutions would be combined in a single enterprise-wide system
with the flexibility to manage various use cases. In reality, financial information is managed
by the ERP or CPOE application, medical information is handled by the EMR and imaging
is handled by DICOM systems. So, instead, organizations should look for an ECM solution
that will help unify this information through robust back-end services to extract data
relevant to EMR and ERP applications. To successfully use a multi-product model, ensure
the information capture mechanisms are aligned across physical and electronic entry
points to the system.
Keys to successfully using ECM as the connective tissue between clinical and
financial operations:
1. Process clarity. The goal should be to automatically move information from clinical uses
into financial and administrative usage.
2. Start simple with process automation. Ensure that all pieces of information contain
some metadata even if it is just the author name, filename and date accessed/created.
3. Take the time to develop metadata libraries. There are many options but yours should
align with the existing clinical workflows and financial workflows.
4. Aligned permissions and data classification. Build a robust classification and permissions
control system that allows departmental workers to get to any document they may need
without signing in again or using different credentials. For example, time-off forms for all
staff, as well as pharmacy drug requests can all be built in the ECM but only visible if you
are part of the right groups. If you make users sign out and sign into a different system,
they will stop using one of your systems–and it won’t be the one with the benefits and
time-off requests.
Modules to prioritize in your ECM purchase
Integrated process/workflow management module that can:
• Provide reporting on instances of each process
• Tie information access to process steps
• Tie document creation to workflow steps
• Integrate into the document library for document access management
• Integrate into data management (as opposed to content/document management) systems
to provide a single point of access for all information related to a workflow/process
• Automate the compilation of process information into a document ready for submission
• Integrate into external systems through HL7-FHIR (FDA’s eCDA and eTMF systems) or
through SMTP with encryption (FIPS 140-2 compliant)
Records management framework
• Audit control for document access
• Audit for who was involved in processes
• Access control management
• Access and audit controls for changes made to processes, documents and system settings

7. 7/8Preparing for a digital future in healthcare
Solution
The right platform will have some of these features:
1. A strong records management core that can be managed by a single compliance or
records manager
2. A BPMN-based workflow/process management module
3. A well-described set of tools to integrate the content into a user’s preferred work
application, API and/or SDK, additional methods to use new XML/HTML-based screen
scrape technology to connect systems
4. Granular access management that can be tied to existing tools, such as Microsoft®
Active Directory®
, with an internal system for when Active Directory settings and
information management needs diverge
5. General system requirements and ease of use so that any department can find value
• Medical codes are not hardwired
• Metadata can be added, mixed, changed to ensure that any document can be
appropriately accessed or deleted based on document relationships or user permissions
ECM provides a solution in managing information across different departments,
particularly in these three areas:
1. Clinical to compliance. Managing the data, building the compliance package and submitting
it is rarely performed by the same person. Multiple people in multiple departments require
access to the same data to revise documents and approve the final copy.
2. Finance to clinical. Purchasing and getting paid for medical products requires
appropriate approvals, documentation and codes that usually are not maintained by
finance or compliance.
3. Human resources. Hiring and maintaining core clinical staff is difficult. It is often handled
by managers on the clinical side but the documentation is managed and updated by HR.
An effective ECM solution captures unstructured information to improve collaboration,
regulatory compliance and, most importantly, patient care. Finding the right solution will
help your organization be equipped to thrive in healthcare’s digital future.
About OpenText
OpenText, The Information Company™
, enables organizations to gain insight through
market leading information management solutions, on-premises or in the cloud. For more
information about OpenText (NASDAQ: OTEX, TSX: OTEX) visit: opentext.com.
Connect with us:
• OpenText CEO Mark Barrenechea’s blog
• Twitter | LinkedIn | Facebook

8. 8/8
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Web sources used for regulations and technical standards for
compliance management
Guidance on EIM for all 21 CFR part 11 orgs (Directly references DoD 5015.2 as a key organizing document):
http://www.fda.gov/ohrms/dockets/98fr/00d-1539-gdl0001.pdf
Consolidating regulatory frameworks in life science: http://www.mastercontrol.com/annex_11
Medical device Fed register of final rule: https://www.federalregister.gov/articles/2014/02/14/2014-03279/
medical-device-reporting-electronic-submission-requirements#h-18
Current eFDR standards: http://www.ecfr.gov/cgi-bin/text-idx?SID=3ee286332416f26a91d9e6d786a604ab&
mc=true&tpl=/ecfrbrowse/Title21/21tab_02.tpl
Computer validation http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
GuidanceDocuments/ucm085281.htm
Nice boil down for pharma: http://www.slideshare.net/jasminnuhic/complying-with-21-cfr-part-11-
understanding-the-role-of-predicate-rules
FDA guidance on computerized control systems: https://www.fda.gov/iceci/enforcementactions/
bioresearchmonitoring/ucm135196.htm
Importance of limited locations for documentation as the basis of FDA compliance: http://nifa.usda.gov/sites/
default/files/resource/Overview%20of%20FDA%20Regulations%20and%20Process%20Validation%20
Considerations.pdf
Overall guidance on complying with FDA requirements through document submission. http://www.fda.gov/
downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm400630.pdf
http://www.fda.gov/AboutFDA/ReportsManualsForms/Forms/default.htm
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/
ElectronicSubmissions/ucm153574.htm
Follow the FDA’s approval process http://www.fda.gov/Drugs/DevelopmentApprovalProcess/
FormsSubmissionRequirements/ElectronicSubmissions/ucm174459.htm
How to understand if you are a BAA: https://www2.idexpertscorp.com/blog/single/hipaa-business-associate-
101-a-primer
Good matrix of the sub parts of HITECH/HIPAA compliance https://www.hlc.org/app/uploads/2014/05/
HIPAA-101-Brief-Materials3-23-15.pdf
Relationship between FDA regulated devices and HIPAA rules: http://www.mddionline.com/blog/devicetalk/
are-your-medical-devices-hipaa-compliant-08-25-15
Example of information database for life sciences: http://www.annalsthoracicsurgery.org/article/S0003-
4975(08)00924-7/fulltext?refuid=S0003-4975(11)01666-3&refissn=0003-4975&mobileUi=0
Really good academic study: http://jamia.oxfordjournals.org/content/21/4/714.figures-only
Clinical research company http://forteresearch.com/news/hipaa-basics-for-clinical-research-qa/
Building BAA relationships: http://info.pharmaseek.com/acton/attachment/18595/f-0019/1/-/-/-/-/PS_
Webinar_HIPAA%20%20Basics.pdf
Automating Audits using AD and ITSM tools https://www.manageengine.com/products/active-directory-
audit/hipaa-compliance-reporting-tool.html
US Government administrative guidance for healthcare administration: https://www.cms.gov/Regulations-
and-Guidance/Administrative-Simplification/HIPAA-ACA/index.html
Enabling Meaningful use (and MACRA) technically: http://healthcaresecprivacy.blogspot.ca/2012/10/mu2-
encryption-and-hashing.html?m=1
Dealing with paper and data residue form copiers and printers: http://www.milner.com/company/blog/
technology/2015/06/24/how-to-make-copiers-and-printers-hipaa-compliant