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Regulations and compliance for enterprise mhealth applications


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Mobilizing healthcare applications Security Concerns and Challenges Defining the application –

'Does your mobile app need FDA approval?

Secure your mobile app – Understanding HIPAA compliances A.Assess the user base

B.Design a strategy C.Deploy and Manage


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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. 4 5 6 8 13

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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.


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.

mHealth market 2015: 500m people will be using healthcare smartphone applications (research2guidance, November 2010 report)


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


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

Brainstorm and evaluate Possible considerations for app not being subject to FDA approval How is the data going to be

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

Make sure the data to the app is 1


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. Does the app provide real-time

updates of a patient?

3 The app should not

Monitor the patient in real-time Notify users on alarms about the physical condition of a patient Patient-specific result using processing algorithms 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


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

What is the type of user-group that will access the application?

Is the application going to be accessed by consumers?

Is it an enterprise-application, which will be accessed only by employees of the organization?

Mobile platforms On what platforms does the mobile application need to be supported? iOS (Apple), Android, Blackberry, Windows or All?

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


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.

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.

Primary risk Areas Exposure of device to Malware Loss of device Access to data through external entities (hacking/ theft) Primary risk Areas Exposure of device to Malware Loss of device Access to data through external entities (hacking/ theft)


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.


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

The four-digit security code can be used for logging into the application when device i in offline mode.

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


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.

been inactive for a specific period of time.

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.


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.


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.

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.

2.For enterprise controlled apps/devices, apply Over-the-Air (OTA) provisioning and management of smartphones.



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.


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.


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