Whether dealing with a common billing process or a complex manufacturing of a pharmaceutical, healthcare and life sciences organizations must integrate a variety of diverse systems while keeping internal and external imperatives in balance.
Regulatory Compliance and Industry Standards Challenges
Healthcare and life sciences organizations must navigate a complex regulatory landscape where regulations are updated and changed frequently. These frequent changes make it a challenge for technology to keep up with reporting requirements for aggregating data into a “single version of the truth.”
Today, it’s not enough to have electronic medical records (EMRs). There are a variety of key healthcare interoperability requirements, from provider, payer, life sciences and processor management to following the highest security standards while ensuring compliance. Providers must keep in mind that:
- U.S. law now requires that for Medicare and Medicaid, healthcare organizations must meet the Meaningful Use Stage 1 criteria where EMRs must be used in a meaningful way—which then requires enabling more applications to process these records.
- HIPAA-covered entities need to use ICD-10 codes to receive payment for healthcare services rendered, or risk providing care and not being paid. Even life sciences organizations need to pay attention to ICD-10, for drug indication and label language. Given the complexity of ICD-10 codes compared with ICD-9, current data mapping is now obsolete, requiring new application integration and mapping scenarios.
- One of the most significant challenges healthcare organizations must address is compliance with Health Level-7 (HL7), the standard for information exchange between medical applications (as well as payers and processors).
- 21 CFR Part 11 sets the standards for which the Food and Drug Administration (FDA) accepts data from life sciences firms, including all electronic records and signatures, whether for research and development, manufacturing, laboratory operations or clinical trials.
- United Kingdom NHS Interoperability Toolkit (ITK) compliance: UK healthcare organizations increasingly expect healthcare applications and platforms to comply with NHS standards. Dell Boomi is demonstrating this compliance – view our first ITK Accreditation Certificate.
Remaining competitive requires an integration solution that’s flexible and responsive enough to handle the frequent updates to regulatory compliance requirements and industry standards.
Modernizing and Digitizing Healthcare IT
The first step involves modernizing IT systems while ensuring compliance with data protection laws—because standards and metrics drive the delivery of care in these models. Evaluating those metrics involves accessing far more data than ever, and highlights the need for improved interconnection among systems such as electronic medical records (EMR), Health Information Exchanges (HIE) and Patient Administration Systems (PASs).
At the provider level, medical practice and business operations must be organized into a seamless machine to run physicians’ offices and to generate safe, measurable and economically viable outcomes for patients while driving efficiency for the practice. These would involve managing:
- financial systems
- billing systems
- ordering systems
- supply chain systems
- ordering systems
- procurement systems
Any move to digitize medical records and modernize existing IT systems will involve working with legacy or clinical systems from a variety of vendors, connecting data from several branches of hospitals or healthcare networks.
While your organization may have interface engines that were originally created to help connect legacy interfaces, these engines may now be too expensive and inflexible to maintain, configure and adapt.
In some cases, they’ve may even be a hindrance to today’s interoperability needs—a problem that’s exacerbated when extended to cloud integration and mobile deployment. These proprietary interfaces are also hard to maintain, and as vendors sunset legacy products, continuous support isn’t guaranteed.
Mergers and Acquisitions Highlight Challenges for Life Sciences
With mergers and acquisitions (M&A) among pharmaceutical companies and biotech firms, realizing the value from the M&A activity means addressing interoperability challenges. Time to market is a key driver for pharmaceutical companies—and the same applies to data integration.
When the goal is beating your competitors to establish market dominance while a drug is still protected by patent or exclusive marketing rights, speed is critical—despite the challenges of operating under intense regulatory scrutiny and addressing enormous data requirements. Even when submitting clinical trial data for the FDA’s rigorous, data-intensive drug approval process, data is the driver.
Starting with the clinical trial—an intensely collaborative process where facilitating that collaboration requires a significant amount of data sharing—clinical trial data is aggregated from different databases, as it travels back and forth between the sponsoring company and its contract research organizations (CROs). In addition, it’s moving between suppliers, physicians, researchers, partners and customers. So ensuring data integrity requires collecting and aggregating data from multiple systems.
The more efficiently data can be gathered and approved, the faster a pharmaceutical company can bring a drug to market and start generating a return on its investment.
Healthcare Organizations Face Challenges of Mergers and Acquisitions, Too
In a healthcare organization, the business drivers and potential roadblocks that will have an impact on making an M&A a successful business transaction may include speed of value realization, the potential for expensive disruptions, efficient use of resources, quality improvement, and population health management.
In a heavily regulated industry like healthcare, where the compliance landscape is ever-changing, healthcare providers and networks undergoing M&A activity likely focus on providing value-based care, as well as quality. Since many healthcare organizations are embracing the new accountable care payment/revenue models, the move to a value-based reimbursement model is taking center stage, as the previous fee-for-service model fades away.
During an M&A situation, legacy systems and even legacy interface engines necessitate a migration plan, but healthcare organizations face a wide range of challenges here, too:
- Proprietary interfaces are hard to maintain.
- Vendors are sunsetting legacy products so continuous support is dwindling.
- Industry standards—such as HL7, HIPAA 5010 and ICD-10—are changing and evolving.
Legacy systems can be very expensive to operate, and with a diminishing skillset on the market, even harder to configure and change to adapt to new requirements. Those headaches continue when you extend to cloud integration and mobile deployment because the rigid architecture isn’t flexible, and there are complex licensing agreements, renewal processes, and renegotiations that take place.
Dell Boomi: The Ultimate Interoperability Solution
Dell Boomi not only ensures your organization can quickly integrate systems, but it ensures those integrations are flexible enough to allow you to weather the constant change of regulatory compliance. As a flexible, cloud-based solution, Dell Boomi AtomSphere® integration platform as a service (iPaaS) integrates your applications whether on premises, or in the cloud.
And our Master Data Management (MDM) solution provides your organization a “single version of truth” to eliminate the data silos on the ground and in the cloud—the silos that many healthcare organizations struggle with today.
Dell Boomi is a leader in Gartner’s Magic Quadrant for Enterprise Integration Platform as a Service, Worldwide* in part for our patented drag-and-drop functionality and automatic mapping. This allows Healthcare and Life Sciences organizations to qiuckly implement integrations with faster time to value, ease of use and simplicity. Healthcare and Life Sciences organizations benefit from Boomi’s
- Flexible, adaptive architecture featuring our patented Atom® technology, that adapts to your needs —with no coding, no hardware—for secure integration and monitoring. This reduces your time to value through integrations you can customize, configure and deploy easily—over weeks, not months.
- Emphasis on configuration instead of coding, providing greater speed and eliminating complexity and improving ease of use, thereby increasing your operational efficiency so you can stay current with regulatory changes by allowing users outside of IT—such as business analysts—to create and maintain integrations.
- Centralized development, distributed deployment to relieve operational stress on any one system or node. This allows you to scale as needed to address provider, payer and processor management, and offer compliant message exchanges and healthcare partner enablement through our HL7 connectors.
- Predictable pricing that provides an economically viable solution. This represents a significant cost savings over legacy, one-off integrations.
The result? Dell Boomi helps your organization increase its agility, improve patient care, accelerate revenue, eliminate complexity, and increase cost savings. Contact Dell Boomi today to discover how we can help you.
* Gartner, “Magic Quadrant for Enterprise Integration Platform as a Service, Worldwide” March 23, 2105. Gartner does not endorse any vendor, product or service depicted in its research publications, and does not advise technology users to select only those vendors with the highest ratings or other designation. Gartner research publications consist of the opinions of Gartner’s research organization and should not be construed as statements of fact. Gartner disclaims all warranties, expressed or implied, with respect to this research, including any warranties of merchantability or fitness for a particular purpose.