Navigating the Evolving Landscape of Healthcare Data Interoperability: Implications for Medical Affairs

U.S. healthcare has long suffered from fragmented data silos across hospitals, clinics, labs, and insurers. For years, MSLs and Medical Affairs teams struggled to assemble a complete picture of patient care because each system “cannot seamlessly communicate” with the others [1][2]. The 21st Century Cures Act (2016) and its 2020 “final rule” directly target this issue. They mandate open APIs and data standards so that patient records can be accessed through standard methods (not custom interfaces) [3]. In practice, all certified EHR systems must now offer FHIR (Fast Healthcare Interoperability Resources) based APIs that let authorized apps pull (or push) any element of a patient’s record. These policies were explicitly designed to create an ecosystem of “reusable, substitutable apps” that work across any hospital or clinic without special effort [3]. In short, regulations now force an end to legacy workflows like faxing or locked-down databases: data must become “findable, accessible, interoperable, and reusable,” with binding standards to break down silos [1][2]. The rules also target information blocking by providers or vendors – recognizing that misaligned incentives could otherwise re-create closed ecosystems [3]. Overall, these new mandates give Medical Affairs a clear regulatory push toward shared data: hospitals and payers are being driven by law to share health data via FHIR and other common standards, finally enabling connectivity that was long overdue.

FHIR and APIs: The New Data Infrastructure

At the heart of this interoperability revolution is HL7 FHIR – a modern data standard and API framework for healthcare. FHIR was introduced in 2011 to combine the best of older HL7 standards with web technologies (RESTful APIs, JSON/XML, OAuth) [4]. In FHIR, every clinical concept (Patient, Observation, Medication, etc.) is defined as a discrete resource that can link to others. Approved apps can use simple web calls to fetch exactly the fields they need from any compliant EHR. In other words, Pharma companies and tech vendors can now build a single app (for example, a clinical decision support widget or analytics dashboard) that plugs into any hospital’s system using the same FHIR API. As one review explains, such standards “provide a useful framework for standardizing data transmission while maintaining semantic integrity at the patient level,” effectively unlocking data held in legacy systems [2]. In health research and medical affairs applications, FHIR promises to standardize data across disparate sources so that real-world data (RWD) from different clinics can be combined and interpreted consistently [4]. In short, FHIR and RESTful APIs mean that EHR data is no longer trapped behind custom interfaces – it can flow programmatically, enabling near real-time queries of outcomes, lab results, diagnoses, and more. This technical shift (away from point-to-point hospital integrations toward plug-and-play interoperability) will underpin every data-driven Medical Affairs activity going forward.

Transforming Medical Affairs: RWE, KOL Engagement and Information Exchange

These infrastructure changes yield tangible benefits for Medical Affairs and MSLs in the field. First, better interoperability opens the door to richer real-world evidence (RWE). By tapping standardized data feeds, MSL teams can assemble larger de-identified patient cohorts and answer KOL questions about outcomes, safety, or treatment patterns that go beyond published trials. For example, an MSL could use an interoperable data platform to analyze how many patients at leading centers have a specific biomarker or how often they experience a certain side effect – data that previously would have required manual chart review. Regulators like the FDA already expect pharma to use RWE to support new indications or safety assessments per the Cures Act RWE program, so Medical Affairs can take a proactive role in curating and communicating evidence from these sources. (Of course, RWD must be high-quality, and frameworks are emerging to assess fitness-for-purpose [5].

Second, data interoperability enables more seamless stakeholder engagement. Instead of one-way slide decks, MSLs can leverage interactive digital tools that plug into a clinician’s workflow. For instance, some EHRs now support Smart-On-FHIR “knowledge apps” that let doctors launch information modules during a patient visit. Medical Affairs could use these channels to push updated guidelines, outcome dashboards, or even quick surveys to KOLs at the point of care. Likewise, interoperable platforms make it easier to aggregate clinician feedback and questions (for example, through in-app Q&A widgets), creating a two-way exchange of medical information between providers and pharma.

Finally, interoperability aids competitive intelligence. With new API-driven data streams, companies can more readily track adoption and outcomes of both their own therapies and competitors’ products. For example, a pharma analytics team could query a national FHIR-based claims or EHR repository to see regional prescribing trends or switch rates between treatments. Such real-time intelligence can alert MSLs to shifting market dynamics or emerging unmet needs. In essence, the very pain point that MSLs have always faced – fragmented, incomplete insight into real practice – can be eased. Easy access to large, accurate health datasets is required for “real-time” understanding of medical information [1], and FHIR-driven data exchange is the key to achieving that. By solving fragmentation, interoperability finally allows Medical Affairs to deliver richer evidence and more agile support to KOLs and providers [5][1].

Actionable Steps for Medical Affairs Teams

1. Develop Data Literacy & Tools. Train MSLs on healthcare data fundamentals (EHR, claims, registries) and invest in modern analytics platforms that leverage FHIR/REST APIs. For example, use FHIR-powered research networks (like federated EHR databases) or licensed RWD platforms that integrate seamlessly. Ensuring the team can interpret RWD outputs is key to leveraging interoperability.
2. Collaborate with RWE and IT Experts. Partner closely with in-house data science, market access, and IT teams. Define real-world studies and dashboards that MSLs can support. Engage KOLs in registry or retrospective studies that use interoperable data feeds. Working together across functions lets Medical Affairs guide the right data queries (for instance, adjusting for EHR coding differences) and share actionable findings with KOLs.
3. Leverage Digital Engagement Channels. Integrate new data distribution methods into your engagement plans. Use EHR-embedded apps or portals to share up-to-date slides, guidelines, or patient profiles with HCPs. Host virtual scientific exchanges that include interactive data visualizations drawn from FHIR-accessed data. In short, go where the data lives: if providers are on a digital platform, align your content delivery there.
4. Partner with KOLs Using Data. Use interoperable data to strengthen relationships. Share de-identified, aggregated evidence from a KOL’s own health system (with consent) to co-author case series or white papers. Ask KOLs for input on which data elements matter most (e.g. outcomes or subpopulations) and use FHIR queries to gather that information from broader networks. Data-driven collaboration can turn key opinion leaders into active research partners.
5. Hunt for Competitive Insights. Exploit the new data openness to benchmark against competitors. Query EHR/claims networks for usage and outcome metrics of your drug versus alternatives. Track patient journey patterns (e.g. from diagnosis to treatment) at specific institutions. Armed with interoperable data, your intelligence teams can produce market analyses with a level of detail previously unavailable.
6. Advocate Standards Adoption. Encourage your healthcare partners to keep up with standards. Support hospitals in implementing FHIR data-sharing or in using US Core Data for Interoperability (USCDI) terms. Internally, ensure your medical information and regulatory teams align on standardized data vocabularies. The more everyone uses common formats, the richer the shared insights.
7. Stay Informed on Regulations. Continuously monitor ONC/CMS guidance and interoperability initiatives. For example, follow developments in the Trusted Exchange Framework (TEFCA) or new FHIR versions. Ensure Medical Affairs strategies comply with privacy (HIPAA) and “no information blocking” rules. Being up-to-date will help you spot new opportunities (such as pilot programs or public data releases) and avoid compliance risks.

By taking these steps, Medical Affairs and MSL teams can turn the interoperability mandate into a competitive advantage: solving their data-access pain points and delivering more impactful, evidence-based engagement with stakeholders.

References

1. Szarfman A, Levine JG, Tonning JM, et al. Recommendations for Achieving Interoperable and Shareable Medical Data in the USA. Commun Med. 2022;2:86.
2. Balch JA, Ruppert MM, Loftus TJ, et al. Machine Learning–Enabled Clinical Information Systems Using FHIR Data Standards: Scoping Review. JMIR Med Inform. 2023;11:e48297.
3. Gordon WJ, Mandl KD. The 21st Century Cures Act: A Competitive Apps Market and the Risk of Innovation Blocking. JMIR Med Inform. 2020;22:e24824.
4. Vorisek CN, Lehne M, Klopfenstein SAI, et al. Fast Healthcare Interoperability Resources (FHIR) for Interoperability in Health Research: Systematic Review. JMIR Med Inform. 2022;10:e35724.
5. Zou KH, Berger ML. Real-World Data and Real-World Evidence in Healthcare in the United States and Europe Union. Bioengineering (Basel). 2024;11(8):784.