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Get ‘IDMP Ready’ with Modern Data Management

There is no better time than now for pharma & medical device companies to modernize their product information management and comply with IDMP (Identification of Medicinal Products). Non-compliance might result not only in hefty penalties (as high as 5% of annual EU gross revenue) but also in poor operational efficiencies. Experts advise to kick-off the IDMP initiative now and reconfigure the data model later when the final guidelines are published by EMA (European Medicines Agency), FDA (Food & Drug Administration) or other similar regulatory body.

IDMP is a set of five ISO norms which has been developed in response to a world-wide demand for internationally harmonized specifications for medicinal products. Following a phased implementation process, pharma & medical device companies will be required to submit data on medicines and medical devices to EMA in accordance with these formats and terminologies. The implementation of the IDMP standards will help achieve operational savings for these companies as well as improve the health and safety of the human population.

Product information in pharma & medical device companies is distributed across several departments or lines of business in a myriad of different systems, authored in different formats, in multiple languages, and different terminologies. Harmonizing this data within a single organization itself is a big challenge, but doing so across the continents and coming up with common standards is a daunting task. It is for these reasons, the timelines for implementations of IDMP standards have been changed a few times. This valuable grace period should be utilized by these organizations in planning and preparing for this ambitious, enterprise-wide initiative.

As per the EMA, the underlying challenge of IDMP is fundamentally a Master Data one. EMA’s approach to implementing the ISO IDMP standards is based on the four domains of master data in pharmaceutical regulatory processes: substance, product, organization and referential (SPOR) data. Pharma & medical device companies that would be regulated as per the IDMP standards by the EMA, should be right now actively getting a handle around where is their product data scattered within their enterprise, and how they would manage it scientifically.

A Modern Data Management Platform allows you to create a strong underlying master data foundation for IDMP objects in the cloud as well as derive actionable insights from various data domains, their relationships, and the interactions among them by leveraging graph technology. It not only creates the reliable product data foundation but also offers flexible product hierarchies by markets, brands, segments and geographies that can be categorized, organized and analyzed from multiple perspectives.

It is extremely easy to write metadata based definitions of IDMP objects in an agile, real-time configurable data management platform. Not only can you start with the definitions of these objects as per the evolving IDMP standards, you can also extend these definitions over time based upon your varied business needs. You can create other objects over and above the IDMP objects, define relationships among themselves, and capture transactional data that will eventually provide valuable insights. Reference Data Management is yet another underlying capability of a Modern Data Management Platform that helps master reference data from multiple systems. In the world of IDMP, the reference data can be sourced from different systems. As an example, Global Substance Registration System (G-SRS) is one of the major source systems that implements and supports the ISO-11238 substance types and controlled vocabularies (CVs).

Last but not least, a cloud-based Modern Data Management Platform requires no on-premises installation, hardware or maintenance. Instead of buying servers, installing and patching software, and constantly wrestling with how to handle the relentless growth and diversity of data, your IT teams can focus on delivering relevant, operational intelligence to business users. Such platform is deployable in a fraction of the time and cost compared to the traditional MDM solutions, providing significantly faster time to value. Also, it provides fine-grained, attribute-level, visibility of who searched for, who looked at, and who modified what data, in logs that can be tracked and monitored for security and compliance.

Business leaders who can adopt a modern data management philosophy, program management teams that can help drive the project, and technology partners who can help implement specialty technologies, would need to come together to make full, organization-wide IDMP compliance a reality. Using a next generation data management platform for your IDMP implementation will not only reduce the time to compliance in a cost-effective manner, but it will empower your organization to create a futuristic data platform that will stay current. In addition, it will help you build new capabilities such as providing transparency to your consumers, facilitating acquisition of other products or companies, and identifying emerging product safety risks apart from meeting regulatory requirements and delivering cost savings.

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Why did a Horizontal Modern Data Management Provider Invest in HITRUST CSF Certification?

Last month Reltio announced HITRUST CSF Certification in a press release. While this wasn’t exactly headline news it was significant for our customers and partners, present and future in the Healthcare and Life Sciences Industries (HCLS).

The foundation of all HITRUST programs and services is the HITRUST CSF, a certifiable framework that provides organizations with a comprehensive, flexible and efficient approach to regulatory compliance and risk management. In the same week John Houston, VP of security and privacy and associate counsel, at the University of Pittsburgh Medical Center (UPMC ) sounded an alarm in an article “UPMC Security Chief Sounds Warns Many Cloud Computing Vendors Lack Ability to Appropriately Secure Health Data” in which he calls upon cloud providers to be more transparent about their security offerings and to support standards such as HITRUST.

Developed in collaboration with healthcare and information security professionals, the HITRUST CSF rationalizes healthcare-relevant regulations and standards into a single overarching security framework. Because the HITRUST CSF is both risk- and compliance-based, organizations can tailor the security control baselines based on a variety of factors including organization type, size, systems, and regulatory requirements.

By continuing to improve and update the CSF, the HITRUST CSF has become the most widely-adopted security framework in the U.S. healthcare industry. This commitment and expertise demonstrated by HITRUST ensures that healthcare organizations leveraging the framework are prepared when new regulations and security risks are introduced.

Fundamental to HITRUST’s mission is the availability of the HITRUST CSF that provides the needed structure, clarity, functionality and cross-references to authoritative sources. The initial development of the CSF leveraged nationally and internationally accepted standards including ISO, NIST, PCI, HIPAA, and COBIT to ensure a comprehensive set of baseline security controls. The CSF normalizes these security requirements and provides clarity and consistency, reducing the burden of compliance with these requirements that apply to healthcare organizations.

Typically HITRUST has traditionally only been applied for, and awarded to Healthcare specific companies, whose sole focus is that industry and the handling of HIPAA and other patient-level compliant grade data. A search of HITRUST certification for legacy and cloud-based data management platforms yields no qualifying companies prior to Reltio.

Although Reltio is a horizontal Modern Data Management Platform as a Service, that is multi-tenant and industry agnostic, we have a significant number of HCLS companies who rely on us to manage and provide business facing application-level access to sensitive data. Over the last year, we have invested a tremendous amount in resources and cost to ensure that our platform compliance meets both industry and geographic-specific regulatory and compliance requirements. We anticipated the need for companies to want to use Reltio for data (e.g. Patient data) under HIPAA compliance, and were determined to go through the rigor and challenges to achieve full HITRUST CSF certification.

In conjunction we also appointed Peter Bierfeldt as Chief Information Security Officer (CISO), to lead customer security, privacy, validation and compliance efforts at Reltio. Peter has more than 20 years of industry experience, including leading complex, large enterprise IT programs and projects. He also has over 10 years of experience in the pharmaceutical industry, and has managed the global delivery of a multi-million-dollar IT program for a top 10 pharmaceutical organization.

With HITRUST CSF added to Reltio’s SOC type compliance, the growing roster of HCLS companies using Reltio Cloud can now confidently extend to sensitive data beyond what they were able to manage with other tools that are unable to provide this level of support.