Apple has sold millions of iPads in the past 18 months. The adoption of the device in the market is phenomenal. This trend is reflected in Life Sciences & Healthcare industry as well. A mobile Health News article (2012: About 62 percent of physicians use tablets) puts the adoption of tablets by the physicians at 62%. Another report by IDC puts the Smart Devices sales exceeding the combined sales of laptops and desktops. All these trends are indicative of the rate of adoption of mobile and smart devices by the population in general. The healthcare and life sciences industries are no exception to this.
While the adoption is growing in general, the challenges and bottlenecks are numerous for adoption of the devices in an Enterprise/Business setting. To make this even more complex, consider using the tablets and smart phones in a validated environment to capture and manage personal health information of patients.
Some key questions to be asked while considering adoption of Mobile devices in a validated environment are:
- Will the device and application be considered a Mobile Medical Device?
- If so, what should we do to validate the application?
- What are the regulatory requirements and guidance from the agencies?
- Should we consider a native application vs. a web based application?
- If so, how does the validation activities and artifacts differ?
- Would the data be stored on the device or would it be transferred to the server as soon as it is captured?
- Should we make it available offline to enable usage without internet connectivity?
- What are the synchronization challenges?
- How do we handle identity management?
- How do we ensure data security?
While some of these questions are applicable to any enterprise mobile application, they are even more important to consider if the Mobile device is slated to be used in a regulated environment. For customers in the US, one key document to be considered as input, to answer some of the questions, is FDA’s DRAFT Guidance for Mobile Medical Applications.
mHIMSS Policy & Regulatory Implications Workgroup has provided a very good summary of how the guidance should be interpreted with respect to Mobile Medical Applications. You can read the summary here (needs registration).
FDA also provides more useful information on Mobile Medical Applications here.
I look forward to comments and insights into any specific experiences that you might have had with respect to developing Enterprise Mobile Applications in a regulated environment. These applications may or may not be companion applications to devices, but may fall under the MMA purview as defined in the guidance.
Jumpstart your PV Operational Efficiency Improvement Initiatives through Oracle Pharmacovigilance Operational Analytics (OPVA)
I attended Oracle Open World (OOW) recently during the week of Oct 2nd. I got a sneak peek of the newly released Oracle Pharmacovigilance Operational Analytics tool. This tool is intended to provide a jumpstart to the efforts of Safety & Pharmacovigilance departments of MAHs and CROs in being able to monitor the operational performance of the organizations and identify the bottlenecks. The key point to note is that this tool provides only the Operational Analytics and doesn’t include the Scientific Analytics.
Some of the Key business benefits it will deliver include:
- Insights into the case processing operations
- Measure compliance and productivity across the organization
- Provide ability to monitor the KPIs and metrics through dashboards in real time
- Provide ability to drill down to identify the bottlenecks in the process
- Improve productivity and save costs across the organization
- Improve compliance and enable better patient safety
From IT Systems perspective:
- Single repository of operational safety data
- Star schemas that could be populated with data from internal and external sources
- Predefined reports, KPIs, Metrics and Dashboards
- Ability to customize and extend the dashboards and reports
- Ability to view current as well as historical operational performance of organization and individuals
- Out-of-the-box integration with Oracle’s Argus Safety
- Built using Oracle BI (OBIEE) which gives ability to view dashboards on web as well as on mobile devices (iPhones and iPads)
Some of the key dashboards that are provided out-of-the-box:
- Case processing history in terms of volumes, compliance and repetition
- Case processing management in terms of volumes, compliance and workflow state SLA management
- Personal user dashboards with individual’s case management and case history,
Some of the reports include:
- Completed case volume overview and trends
- Pending case volume overview and trends
- Case version line listings
- Individual case workload reports and line listings
OPVA is compatible with Argus Safety 6.0.2 and Argus Safety 7.0.
One of the key uses of OPVA for organizations that want to define additional metrics, KPIs, dashboards and reports is the start schema that is provided with the product. It comes with a set of predefined dimensions and facts that can be leveraged to speed up the process of developing the additional custom dashboards, KPIs, Metrics and Reports.
Dimensions provided by the OPVA schema are:
- List of Values
- User Group
- Case Processing Site
- Enterprise (in a multi-tenant scenario more relevant for CROs)
The pre-built facts into the OPVA data mart are:
- Case Version History
- Case Routing History
- Case Workflow History and
- Pending Cases
I think this is a very good addition by Oracle to its stable of products and compliments the existing tools quite well. This is also a very good tool for customers wanting to jumpstart their efforts to measuring their safety operations (aka Case Processing), identifying the bottlenecks in terms of compliance and productivity and rein in costs through improvement plans to enhance these aspects.