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 For customers in the US, one key document to be considered as input, to answer some of the questions, is FDA’s DRAFT Guidance for Mobile Medical Applications.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.
Implementing FDA REMS Elements to Assure Safe Use (ETASU) Requirements using a Business Process Management Suite(BPMS)
It is essential that all new products developed and marketed by bio-pharma and device companies are safe to use and fulfill their efficacy requirements. However, it has been our practical experience over many decades that in most cases there are certain unwanted side effects. Hence, to ensure that the benefits outweigh the risks, regulators have been approving certain drugs under strict risk management assurances from the license holders.
In the US, the Federal Drug Administration (FDA) has been trying to address this through various regulations for over five years through Risk Management Action Plans (RiskMAP) and Risk Evaluation and Mitigation Strategies (REMS). The most recent guidance on this subject was issued in September 2009 through “Guidance for Industry Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications”. In this guidance one of the important REMS elements that may be required is “Elements to Assure Safe Use”.
As part of this requirement the NDA/BLA applicants have to take measures to provide safe access for patients to drugs with known serious risks that would otherwise be unavailable. If a product is assessed to fulfill ETASU requirements then the sponsors are required to train and certify health care providers, pharmacies, patients and drugs. The drugs may be released to patients in a controlled manner only upon receiving evidence of their lab results. The sponsors may also have to register the patients and might subject them to certain monitoring as well. In a few cases the sponsor may be asked to extend the certification process to wholesalers, distributers etc. as well.
In order to fulfill the above mentioned requirements sponsors typically set out to build new IT systems. This is a challenging task as there is a possibility that these requirements could change over time and also there aren’t any commercial off the shelf products available in the market to address the specific REMS ETASU requirements.
To overcome this challenge, sponsors can look up to a Business Process Management System (BPMS) that is precisely built to handle such scenarios. Many other industries have successfully used BPMS to meet their ever changing requirements and priorities by integrating their business processes based on rules. Many commercially available BPMS systems typically include a process engine, Business Analytics, Content Management and Collaboration tools. These BPMS system building blocks can be effectively leveraged to fulfill the ETASU requirements by effectively providing features like Rules management, Content Management, Training Management, Patient/Provider/Pharmacy Registries, Collaboration Portal/Website, IVR/IWR, 21 CFR Part 11 compliance, Audits and integration with other enterprise applications.
My Article on the same topic is published on “Drug Safety Directions” Website. You can access the article here: “Implementing FDA REMS Elements to Assure Safe Use (ETASU) Requirements using a Business Process Management Suite“.