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 New Brunswick, NJ, United States with the consumer division being located in Skillman, New Jersey. The corporation includes 250+ subsidiary companies with operations in over 57 countries and products sold in over 175 countries. Johnson & Johnson's brands include numerous household names of medications and first aid supplies. J&J would like to build a go-to-mobile strategy for mobilizing various product websites and related content on to mobile to generate customer awareness and build loyalty. Before starting investing into mobile applications, J&J also wanted to evaluate applicability 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 quality requirements that must be followed in the production life cycle of a product for it to be deemed to be of good quality. In healthcare, most of these practices fall into three categories defined by US Food and Drug Administration (FDA) as GCP (Good Clinical Practice), GLP (Good Laboratory Practices) 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 organizations in advisory capacity on healthcare compliance, best practices, mobility strategies, and implementation roadmaps. We ensure that mobile solutions are compliant to the healthcare standards and good practice guidelines set by regulators. We do this with our 3 steps assessment process. Our Advisory Services include Good Practices for Healthcare o GCP: Good Clinical Practice o GLP: Good Laboratory Practices 1 2012, Endeavour Software Technologies

o cGMP: Current Good Manufacturing Practice HIPAA Corporate Integrity Agreements (CIA) Case Study: Mobility Strategy Advisory for Johnson & Johnson As a 1st step towards mobility adaption, J&J decided to take a holistic approach towards mobility and evaluate impact of healthcare compliance and good practices on mobile implementation. The challenges include Assessment of healthcare Good Practice (GxP) requirements and how do they impact J&J as it 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 ndeavEndeavour followed 3 step MOA process and worked Cl with J&J executive management and various business teams to identify, strategize and recommend strategy & roadmap mobile to develop mobile solutions following best practices. Value Gained by Johnson & Johnson Endeavour helped J&J evaluate good practices, healthcare regulatory compliance and its applicability and impact on J&J mobile applications. Further, Endeavour also analyzed existing product websites, marketing content and helped J&J evaluate need of a customer loyalty platform and best approach towards mobilizing more than 275 global websites. The deliverables were in the form of a strategy report, proof of concepts for quick-win applications, and phased wise implementation 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 requirements imposed by the nature of the mobile platforms. Relevant GxPs require various records to be maintained during the development life cycle of the application. FDA does not have a separate class or segment for healthcare applications running on mobile devices. Applications are either classified as class 2 or class 3 devices or in extreme cases as new drugs. Looking at the various phases of mobile software development, it is possible to identify to a 2 2012, Endeavour Software Technologies

large degree the generic guidelines that apply, and the corresponding record keeping requirements that these guidelines impose. Adherence however has its own overheads and constraints. To ensure that GxP regulations are followed, Endeavour recommended J&J to ensure that it works only with those vendors who understand GxP regulations and follow its provisions. HIPAA & its impact on Mobility for J&J HIPAA or the Health Insurance Portability and Accountability Act of 1996 is an important legislation in the US and has a strong impact on the development of software for healthcare applications. 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 is indirect impact of Title 1 on software development, there is a very widespread and direct impact of Title 2 of HIPAA on healthcare software development. The provisions of this act are especially applicable for mobile healthcare applications. HIPPA also aims to prevent healthcare fraud and implement healthcare reform and defines a set of rules that govern privacy and secrecy of information (especially Protected Health Information or PHI). J&J directly or via its holding companies or subsidiaries handle PHI frequently. In some cases, it may be a very direct handling of PHI that may include updating key pieces of a patients health record. 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 and security rules). HIPAA & its impact on J&J solutions development Any software that used by a covered entity or in general that handles PHI must be developed after taking into account the impact and requirements of HIPAA. The impact of HIPAA is on all phases 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&J Healthcare practice is governed by stringent and comprehensive laws and regulations that have very 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 are already very high. In addition, if found in violation of regulations, the US Department of Health and Human Services (HHS) may exclude a provider from participating in the Medicare and the Medicaid programs. To avoid these adverse fallouts, providers may need to negotiate a CIA or a Corporate Integrity Agreement with the HHS. Endeavour experts recommended J&J to ensure that its own compliance programs are flexible enough to take into account additional impositions from a CIA. In addition, if a CIA is imposed on 3 2012, Endeavour Software Technologies

any subsidiary, lessons learnt must be propagated across the organization to avoid similar issues elsewhere. In general Endeavour recommended that a proactive approach to compliance would minimize the chances of liability and subsequent CIA. Strategic Advisory for SMS Solutions Development Roadmap After Voice, SMS is the most used application on mobile devices across the world. Billions of messages are sent across the world every day. SMS is particularly popular in the Asia-Pacific region, Europe, Australia. Its popularity in the USA and the rest of the world is growing exponentially. According to Gartner 2.1 trillion messages will be sent in the year 2010 from the Asia-Pacific region alone and according to CTIA 4.1 billion messages were sent per day in the US in the first half of 2009. SMS offers J&J unique opportunities to reach out and connect with its consumer base across the globe. J&J can engage the consumer in many ways ranging from marketing campaigns, loyalty (via rewards, community memberships), driving adherence to healthcare practices and medication courses, creating awareness about healthier lifestyle choices via information dissemination and education through SMS, feedback about products and many others.

About Endeavour Endeavour is a specialist mobility company and has been exclusively focused on strategic mobility advisory and mobile solutions development since 2002. Based on our growth over the last decade Endeavour 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. 4 2012, Endeavour Software Technologies