Strategy for Mobile Enabling the Entire Web Portfolio - Fortune 50 Firm

8/2/2019 Strategy for Mobile Enabling the Entire Web Portfolio - Fortune 50 Firm

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1 2012, Endeavour Software Technologies

Regulatory Compliances&

Its Impact on Mobility for Leading Healthcare Products Firm

Johnson & Johnson is an American multinational medical device, pharmaceutical and consumer

packaged goods manufacturer founded in 1886. The corporation's headquarters is located in NewBrunswick, NJ, United States with the consumer division being located in Skillman, New Jersey. Thecorporation includes 250+ subsidiary companies with operations in over 57 countries and productssold in over 175 countries. Johnson & Johnson's brands include numerous household names ofmedications and first aid supplies. J&J would like to build a go-to-mobile strategy for mobilizingvarious product websites and related content on to mobile to generate customer awareness andbuild loyalty. Before starting investing into mobile applications, J&J also wanted to evaluateapplicabili ty and impact of healthcare compliance on J&J mobility.

Good Practice (GxP) Requirements for healthcare industry

Good Practice guidelines are used in many industries to define the direct and indirect qualityrequirements that must be followed in the production life cycle of a product for i t to be deemed tobe of good quality. In healthcare, most of these practices fall into three categories defined by USFood and Drug Administration (FDA) as GCP (Good Clinical Practice), GLP (Good LaboratoryPractices) and cGMP (current Good Manufacturing Practices). Commonly grouped together as GxP,these guidelines are relevant to the mobile healthcare industry and medical device manufacturers.

Applicability of GxP regulations in different phases of a drugs development

Regulatory Assessment Services Offered by Endeavour

Endeavour experts have rich healthcare experience and are helping large healthcare organizationsin advisory capacity on healthcare compliance, best practices, mobility strategies, andimplementation roadmaps. We ensure that mobile solutions are compliant to the healthcarestandards and good practice guidelines set by regulators. We do this with our 3 steps assessmentprocess. Our Advisory Services include -

Good Practices for Healthcareo GCP: Good Clinical Practiceo GLP: Good Laboratory Practices


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o cGMP: Current Good Manufacturing Practice HIPAA Corporate Integrity Agreements (CIA)

Case Study: Mobility Strategy Advisory for Johnson & Johnson

As a 1 st step towards mobility adaption, J&J decided to take a holistic approach towards mobilityand evaluate impact of healthcare compliance and good practices on mobile implementation. Thechallenges include -

Assessment of healthcare Good Practice (GxP) requirements and how do they impact J&J asit considers leveraging mobile opportuity?

Go-to-mobile strategy at J&J? What considerations should be taken into account? What strategy should J&J adapt towards mobile enabling existing websites, marketing

content for new products. What factors need be considered to efficiently manage mobility assets at J&J. What factors

will be important going forward? How to leverage SMS based applications in emerging ecominies to drive sales, upush

customer coupons? What does Endeavour recommend? What are ideas, trends and possibilities for mobility solutions that Endeavour projects for

J&J?

Regulatory Compliance Assessment - Endeavours Approach

Value Gained by Johnson & Johnson

Endeavour helped J&J evaluate good practices, healthcare regulatory compliance and itsapplicability and impact on J&J mobile applications. Further, Endeavour also analyzed existingproduct websites, marketing content and helped J&J evaluate need of a customer loyalty platformand best approach towards mobilizing more than 275 global websites. The deliverables were inthe form of a strategy report , proof of concepts for quick-win applications, and phased wiseimplementation roadmap followed by an executive presentation to J&J execution team.

Good x Practice (GxP) & its impact on Mobility for J&J

The approach to develop GxP compliant mobile solutions is similar with additional requirementsimposed by the nature of the mobile platforms. Relevant GxPs require various records to bemaintained during the development life cycle of the application.

FDA does not have a separate class or segment for healthcare applications running on mobiledevices. Applications are either classified as class 2 or class 3 devices or in extreme cases as newdrugs. Looking at the various phases of mobile software development, it is possible to identify to a

Endeavour fol lowed 3 step MOA process and workedwith J&J executive management and various business teamsto identify , strategize and recommend strategy & roadmapto develop mobile solut ions following best practices.


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large degree the generic guidelines that apply, and the corresponding record keepingrequirements that these guidelines impose.

Adherence however has its own overheads and constraints. To ensure that GxP regulations arefollowed, Endeavour recommended J&J to ensure that it works only with those vendors whounderstand GxP regulations and follow its provisions.

HIPAA & its impact on Mobility for J&JHIPAA or the Health Insurance Portability and Accountability Act of 1996 is an importantlegislation in the US and has a strong impact on the development of software for healthcareapplications.

HIPAA has two main provisions: Protection of health insurance coverage for those who are changing or have lost jobs. Administrative Simplification (AS) via national standards for healthcare transactions and

national identifiers for entities involved in healthcare.

These two main provisions are termed Title 1 and Title 2 of the Act respectively. While there isindirect impact of Title 1 on software development, there is a very widespread and direct impactof Title 2 of HIPAA on healthcare software development. The provisions of this act are especiallyapplicable for mobile healthcare applications. HIPPA also aims to prevent healthcare fraud andimplement healthcare reform and defines a set of rules that govern privacy and secrecy ofinformation (especially Protected Healt h Information or PHI).

J&J directly or via its holding companies or subsidiaries handle PHI frequently. In some cases, itmay be a very direct handling of PHI that may include updating key pieces of a patients healthrecord. In other cases, PHI may be referred to in varying degrees of details. In all these cases,irrespective of the extent J&J must follow HIPPA regulations particularly Title 2 (the privacy andsecurity rules).

HIPAA & its impact on J&Jsolutions developmentAny software that used by a covered entity or in general that handles PHI must be developedafter taking into account the impact and requirements of HIPAA. The impact of HIPAA is on allphases of the SDLC right from the requirement analysis phase to the deployment of the project.Special testing needs to be carried out to ensure that the software is HIPAA compliant.

Corporate Integrity Agreements (CIA) & its impact on Mobility for J&JHealthcare practice is governed by stringent and comprehensive laws and regulations that havevery complex compliance requirements. Even with the best efforts providers may find themselves

facing the liability in fraud and abuse cases. The legal costs of defending against such cases arealready very high. In addit ion, if found in violation of regulations, the USDepartment of Healthand Human Services (HHS) may exclude a provider from participating in the Medicare and theMedicaid programs. To avoid these adverse fallouts, providers may need to negotiate a CIA or aCorporate Integrity Agreement with the HHS.

Endeavour experts recommended J&J to ensure that its own compliance programs are flexibleenough to take into account additional impositions from a CIA. In addition, if a CIA is imposed on


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any subsidiary, lessons learnt must be propagated across the organization to avoid similar issueselsewhere. In general Endeavour recommended that a proactive approach to compliance wouldminimize the chances of liability and subsequent CIA.

Strategic Advisory for SMS Solutions Development RoadmapAfter Voice, SMS is the most used application on mobile devices across the world. Billions ofmessages are sent across the world every day. SMS is particularly popular in the Asia-Pacificregion, Europe, Australia. Its popularity in the USA and the rest of the world is growingexponentially. According to Gartner 2.1 trillion messages will be sent in the year 2010 from theAsia-Pacific region alone and according to CTIA 4.1 billion messages were sent per day in the USinthe first half of 2009.

SMSoffers J&J unique opportunities to reach out and connect with its consumer base across theglobe. J&J can engage the consumer in many ways ranging from marketing campaigns, loyalty (viarewards, community memberships), driving adherence to healthcare practices and medicationcourses, creating awareness about healthier lifestyle choices via information dissemination andeducation through SMS, feedback about products and many others.

About Endeavour

Endeavour is a specialist mobility company and has been exclusively focused on strategic mobilityadvisory and mobile solutions development since 2002. Based on our growth over the last decadeEndeavour plays role of a Mobility Systems Integrator and helps enterprises go mobile.

With over a decade of proven mobility expertise, enabling award-winning customer deployments,Endeavour is evolving into one of the largest independent enterprise mobility company globally.

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Strategy for Mobile Enabling the Entire Web Portfolio - Fortune 50 Firm