Healthcare organizations and software firms looking to make investments in mobile applications need to assess implications of HIPAA and FDA in order to protect patient health information and ensure compliances are met. This document outlines some of the key evaluation criteria on regulations and security considerations in healthcare sector that need to be addressed while implementing mobility applications.

1. Regulations and compliance for enterprise mHealth applications

2. Contents
Mobilizing healthcare applications 4
Security Concerns and Challenges 5
Defining the application –
'Does your mobile app need FDA approval? 6
Secure your mobile app – Understanding HIPAA compliances
8
A.Assess the user base
B.Design a strategy
C.Deploy and Manage
Conclusion 13
About Us
RapidValue is a leading international professional services firm focused on building and managing
highly scalable mobile and cloud applications for business. RapidValue was founded in 2008 by
senior executives from Deloitte, IBM, Oracle, and Infosys to enable enterprises to deploy
disruptive solutions in consumer and enterprise mobility. RapidValue delivers its services to
companies throughout the world and has offices in United States and India.
RapidValue has deployed numerous mHealth solutions in the healthcare industry for leading
hospitals and software companies in the world. Our industry experts have helped companies take
the big next step in implementing mobility solutions and improve the overall quality of patient
care.
For more information about RapidValue:
Visit us online at www.rapidvaluesolutions.com
Visit our blog at www.rapidvaluesolutions.com/blog
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3. Healthcare organizations and software firms looking to make investments in mobile applications
need to assess implications of HIPAA and FDA in order to protect patient health information and
ensure compliances are met. This document outlines some of the key evaluation criteria on
regulations and security considerations in healthcare sector that need to be addressed while
implementing mobility applications.
© RapidValue 2012 | www.rapidvaluesolutions.com

4. mHealth market 2015: 500m people will be using healthcare smartphone applications
(research2guidance, November 2010 report)
Mobilizing healthcare applications
The rapid explosion of mobile platforms and adoption of smart devices have provided greater
flexibility and opportunity for physicians and other staff at hospitals to deliver real-time
information at the Point of care. Mobile healthcare, or what is more commonly called as mHealth,
has created 'a channel to facilitate, communicate and deliver healthcare services via mobile
communication devices'.
Over the last few months, increasing number of mHealth apps have gained traction that help
physicians and other healthcare providers to keep track of reference drugs, monitor patient
health records and status, and also manage schedules. While this provides a plethora of
opportunities and possibilities for healthcare organizations to reduce costs and improve
efficiency, this increased mobility has created new challenges towards healthcare IT.
This guide will provide a simple prescription to IT teams to assess and identify basic requirements
and help healthcare organizations reduce risk, improve operational efficiencies and achieve
compliance goals enabling them to provide a higher quality of patient care. The whitepaper
combines industry's best practices along with RapidValue's experience in implementing solutions
for many customers.
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5. Security concerns and challenges
The influx and usage of mobile devices have threatened the traditional policies and processes
towards security. The mode of data transmission over the last few years through client/server
approaches and fixed-line infrastructures have been obsoleted with mobile devices accessing
corporate resources and applications from anywhere, cloud services, remote mobile desktops
and social networks.
As more sensitive information is being fed into mobile applications and into the network cloud in
general, the complete security, privacy and regulatory compliance of such information must be
assured. Since security breaches are not uncommon in any industry, the healthcare industry has
mandated a few regulations and compliansces to ensure patient information is safe.
HIPAA (Health Insurance Portability and Accountability Act) - HIPAA in correlation with PHI
(Protected Health Information) requires health care organizations ensure that applications
are secure, and that sensitive patient and business data is protected when in use, during
transmission, or when stored in a mobile device.
FDA regulations - Federal Food, Drug, and Cosmetic Act requires that any stand-alone
device or an accessory (software applications) that is directly consumed by the end user is
subjected to regulations and approval by the FDA.
HITECH (Health Information Technology for Economic and Clinical Health) Act - HITECH is
part of the American Recovery and Reinvestment Act of 2009 (ARRA). The HITECH Act is
intended to encourage more effective and efficient healthcare through the use of
technology, like implementing electronic health records (eHR), thereby reducing the
healthcare costs and enabling greater access to the system. It aims to address the privacy
and security concerns associated with the electronic transmission of health information
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6. Defining the application – 'Does your mobile app need FDA approval?’
One of the key steps in defining the security compliance strategy for your mobile app is to
determine whether the application requires FDA approval.
FDA clearance is typically required for apps that are involved in diagnosis, treatment, cure or
mitigation of a device. A few examples are given below:
Standalone device – Device in finished form, perhaps ready to use with accessories with an
intended sale to end-user. Example: iPod touch integrated with an external device to view the
blood pressure of a patient.
FDA clearance – Yes, requires assessment for exemption
Accessory – Software/articles within a standalone device intended for use by end-user.
Example: a) An app that is used by a patient to download information from a blood glucose
meter. B) An app focused on helping people with weight loss and everyday management of
diabetes.
FDA clearance - Requires assessment for the type of application
On the other hand, applications that are informational and reference-only do not require FDA
approvals.
So how do we really know if the app developed will be subjected to FDA approval or not? Based on
research and experience over the years, we at RapidValue suggest performing an evaluation on
the below set of questions for the app not to be subjected to FDA approval
Possible considerations for app not being
Brainstorm and evaluate
subject to FDA approval
1 How is the data going to be Make sure the data to the app is
input/entered into the app? Entered manually
Not connected to external
device/machine through which it receives data
Does not require physical contact with
the patient specimen
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7. 2 What is the output of the app The output
Should not connect to any other device and
guide with any instruction.
Should only interpret the input and
provide meaningful data to the patient
Should not cure/mitigate/treat the patient.
3 Does the app provide real-time The app should not
updates of a patient? Monitor the patient in real-time
Notify users on alarms about the
physical condition of a patient
Patient-specific result using
processing algorithms
4 RapidValue's assessment
Typical Apps that do not need approval
Wellness related app like track/log/record food habits, physical fitness exercise
Medical reference application
Medical EHRs/PHRs
Apps that improve efficiency like mobile hospital management care (mHMC),
workflow management
Practice-management applications like track billing, determine medical
billing codes, remote physician consultation (mPrescribing) and appointments,
Apps that need approval
PACS apps (Picture Archiving and Communication Systems) that display
radiological images for diagnosis is classified under class II PACS like X-rays
scan reports.
Monitor blood pressure of patient, display heartbeat
of a patient, attachments of ECG reports , device connected to patient
to monitor sleep pattern
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8. Secure your mobile app - Understanding HIPAA compliances
For any healthcare application, security and compliance go hand in hand and it is absolutely
essential to adopt all healthcare compliances and regulations including HIPAA, HITECH, ITRF
Regulation or PCI/PHI compliances governing the Healthcare sector.
While a technical architect or product manager takes the decision of whether an application is
subjected to FDA regulation, compliances and security need to be incorporated by the
development team building the application.
Below are the key steps in ensuring a design that addresses compliance and regulation
requirements.
A. Assess the user base
Unlike applications that run on desktop environments where majority of systems run on a single
platform/operating system, the market share of mobile platforms is pretty fragmented and
Brainstorm Diagnose
1 What is the type of user-group Is the application going to be accessed
that will access the application? by consumers?
Is it an enterprise-application, which
will be accessed only by employees
of the organization?
2 Mobile platforms On what platforms does the mobile
application need to be supported?
iOS (Apple), Android, Blackberry,
Windows or All?
3 Server requirements Is the application a stand-alone app
or does it communicate with backend
server for data synchronization?
What will be the application usage at
most times? Will the application be
accessed and used by large user base?
We need to ensure bandwidth of the
server handles
Assessing information on the above questions will help the IT team to strategize and tailor
unique security policies on corporate servers constantly accessed by wireless devices
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9. B. Design a strategy
Over the very few years of inception, smartphones have got smarter and powerful by the year
with the capabilities of communicating through multiple channels combined with significant
processing power and large storage capabilities. Hence these devices have become the easiest
threat to data vulnerability and security compared to laptops.
Access to data
through external
entities
(hacking/ theft)
Exposure of
Loss of device
device to Malware
Primary
risk
Areas
The Center for Medicare and Medicaid Services (CMS), which oversees HIPAA security rule
enforcement, has published a 'HIPAA Security Guidance for Remote Use of and Access to
Electronic Protected Health Information' to help organizations determine the best way to protect
ePHI available to mobile device users.
Our framework of implementing a secure mobile application is based around the CMS guidance
with recommendations from a development and implementation perspective.
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10. 1. Secure your device: Make sure the mHealth application requires a set of unique credentials
(username and password) to access the application
Risk scenario: Login credentials are lost/stolen, which could potentially result in unauthorized
access to view/modify ePHI.
Solution.
a) Implement a two-factor authentication for granting remote access to systems that contain
ePHI. Other than username and password,
Create a security question like 'Which city you were born’
Create a four-digit security code that will always be requested when the application has
been inactive for a specific period of time.
The four-digit security code can be used for logging into the
application when device i in offline mode.
a) Access to application using a VPN client connection through 'Cisco anytime connect' or 'RSA
secure ID'.
b) Password protection rules such as 6 character pin, expirations, failure thresholds, data wipe
after failure.
c) Implement a technical process for creating unique user names and performing
authentication when granting remote access to a workforce member.
d) Set up devices to automatically lock after a specified period of inactivity.
e) Whenever a device is stolen, the 'IT help desk' should be notified on the same and a user-
interface should be provided on the backend system for the representative to de-register the
username.
2. Secure your data: Make sure the data sent to the mobile application is secure on the device
as well as during transmission.
Risk scenario: Hacking the network or a mobile device from unprotected access points (like
hotel business center, airport) is a growing concern and can potentially result in loss of ePHI
data
Solution:
a) Prevent downloading and storing of ePHI data on the device whenever possible. Ensure the
data when downloaded is operationally justifiable.
b) Minimize caching of data on browsers for web-based applications.
c) Implement strong encryption solutions (validated encryption AES256 & Triple DES), for
transmission of ePHI using SSL (Secure Socket Layer) as the minimum requirement for mHealth
applications.
d) Create policies to prevent use of and/or encrypt SD cards and other removable media on
mobile devices.
a) Ensure that the server to which all web-services request are sent/received from the mobile
devices is firewall protected.
10
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11. f) Ability to perform 'Remote wipe-off' from the server to delete ePHI data from the device.
Remote wipe-off can be designed in any of the following ways.
Monitor the application 'Agent' continuously during online/offline activities and perform
remote wipe-off from the server for suspicious activities.
Monitor application 'Agent' during online activities and perform remote wipe-off from the
server. If 'Agent' cannot be tracked during offline mode, the data on the device should be
deleted for inactive activity of application for about '5' days.
4
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12. C. Deploy and manage
Once the development team implements the application with the compliances discussed
above, the next step is in assessing how to deploy the application and manage them over
subsequent releases and upgrades.
For applications that are not going to be used by consumers but rather within the organization
employees, we recommend rolling out using the enterprise distribution model, through
which users have access to and download the recommended enterprise apps, receive them in
a secure way over-the-air (OTA), and are alerted to and download updates when available.
Moreover organizations can leverage this feature to keep an accurate inventory of the mobile
apps that are installed at any given time, and be able to monitor them by device and user
groups.
While there is a significant concern about application vulnerability, integrity and user privacy
in Apple app store and Android market, we believe that implementing some of the below
security measures will strengthen the compliance policies significantly.
1.Develop processes to ensure backup of all ePHI data sent/received to the mobile are
preform on the server side regularly.
2.For enterprise controlled apps/devices, apply Over-the-Air (OTA) provisioning and
management of smartphones.
3.Scan for suspicious activities and malware on server network platform regularly.
4.Ensure workforce is appropriately trained on policies and also on the application usage that
require accessing any ePHI data. Recommend users to search for and delete any files
intentionally or unintentionally saved to external devices.
5.Perform regular internal HIPAA audits when an application is planned for an upgrade to
include new enhancements/bug fixes.
4
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13. Conclusion
When considering the trends towards adoption of different digital technologies, today's
healthcare organizations are faced with enormous challenges of compliance and regulation.
As we have witnessed recently over the years, personal information theft have proven to be
costly for organizations, loosing their credibility and being forced out of business.
With robust auditing required for HIPAA security compliance, IT groups can no longer ignore
mobile devices in their security policy implementation. Companies looking to develop
mHealth solutions should look to leverage their existing IT infrastructure, policies, and
services and ensure that newer technologies are seamlessly integrated and add significant
value to the organization by providing quality care for their patients.
Disclaimer
This white paper brings out the evaluation criteria of mobile health apps related to FDA and
HIPAA compliance aspects based on our research, analysis and understanding. Any
architectural assessment and/or design decisions related to the above policies should not be
implemented based solely on the recommendations in the document. RapidValue shall have
no liability for any direct, incidental, or consequential damages suffered by any third party as a
result of decisions/actions taken, or not taken, based on this document.
13 © RapidValue 2012 | www.rapidvaluesolutions.com