Smile CDR — the enterprise platform from Smile Digital Health, built on the open-source HAPI FHIR foundation — is one of the most capable enterprise FHIR servers available, used by major health systems and payers. But its power is in its configurability, and configuring it well (resources, profiles, modules, terminology, interceptors, and scale) takes specialist FHIR engineering. Taction Software implements, extends, and tunes Smile CDR: server configuration, module setup, custom extensions, and performance at scale. We are your implementation partner for Smile CDR; the platform is licensed from Smile Digital Health. For managed cloud FHIR alternatives, see our Azure API for FHIR and AWS HealthLake practices. Schedule a Smile CDR Implementation Strategy Call → (NDA-protected) HAPI FHIR & Smile CDR specialist team · FHIR R4 expertise · HIPAA + BAA When Smile CDR Is the Right Choice Enterprise FHIR Server Requirements Smile CDR fits when you need an enterprise-grade FHIR server with commercial support, rather than building and supporting one yourself. Self-Hosted FHIR Deployment When you need to self-host — for data sovereignty, control, or architecture reasons — Smile CDR supports running in your own environment. Open-Source HAPI FHIR Foundation Because it builds on HAPI FHIR, you get the maturity and extensibility of the leading open-source FHIR implementation with enterprise capabilities on top. Modular Capabilities Architecture Smile CDR’s modular design lets you enable the capabilities you need — terminology, interoperability, MDM, and more — rather than a monolith. Our Smile CDR Implementation Capabilities FHIR Server Configuration Resource type configuration, custom profile implementation, search parameter configuration, and subscription implementation so the server matches your data and integration needs — on our FHIR API development foundation. Module Configuration The terminology module, the Cures Act / interoperability module, the CARIN Blue Button module, and MDM (patient matching / master data management) — configured to your use cases, supporting our CMS interoperability compliance work. Custom Extensions Custom resource types, custom operations, and interceptor development using the HAPI/Smile extensibility model for behavior the platform does not provide out of the box. Performance & Scale Tuning High-volume configuration, database tuning, and caching strategy so the server performs at your data volume and query load. Smile CDR vs Alternatives Smile CDR vs Azure FHIR Azure’s FHIR service is fully managed and cloud-native; Smile CDR offers self-hosting and deep configurability with commercial support. The choice follows your control, hosting, and cloud preferences. Smile CDR vs AWS HealthLake AWS HealthLake is managed with built-in ML; Smile CDR gives you a configurable, self-hostable enterprise FHIR platform. Again, managed-cloud versus configurable-enterprise is the deciding axis. Smile CDR vs Open-Source HAPI FHIR Direct Running HAPI FHIR directly is free but you build and support everything; Smile CDR adds enterprise modules, support, and tooling on top of HAPI. The trade is licensing cost versus the engineering and operational burden of going fully DIY. Common Use Cases We implement Smile CDR as an enterprise FHIR data platform, for Cures Act compliance for payers (CARIN and interoperability modules), for clinical data aggregation, and as a research data platform — all on our custom healthcare software foundation. Engagement Options We work in four common shapes: an initial Smile CDR deployment, custom module development, performance optimization, and migration to or from Smile CDR. Schedule a Smile CDR Implementation Strategy Call → Frequently Asked Questions Smile CDR vs HAPI FHIR direct? Smile CDR is built on HAPI FHIR and adds enterprise modules (terminology, interoperability, MDM), tooling, and commercial support. Running HAPI directly is free and fully under your control, but you build and maintain everything yourself. Smile makes sense when the enterprise capabilities and support are worth the license; direct HAPI when you have the engineering depth and want no licensing. Self-hosted vs managed Smile? Smile CDR can run self-hosted in your environment or in a managed arrangement. Self-hosting maximizes control and data sovereignty; managed reduces operational burden. We help you choose based on your compliance, control, and operations preferences, and implement either. Performance at scale? At high volume, performance depends on configuration, database design, and caching. We tune resource indexing, search parameters, database, and caching, and load-test against your expected volume so the platform stays responsive as data and traffic grow. Cost considerations? There are two cost layers: Smile’s commercial licensing (set by Smile Digital Health and confirmed with them) and the implementation and operations cost. We scope the implementation; the licensing is separate. Against fully self-built HAPI, you trade license cost for far less engineering and operational burden — we help you weigh that honestly. Schedule a Smile CDR Implementation Strategy Call → Reviewed by Taction Software’s healthcare integration and FHIR engineering team. ISO 27001-certified information security management. We are an independent implementation partner; Smile CDR is licensed from Smile Digital Health. PHI is handled under a signed BAA — see our data security practice.

Particle Health gives products a way to pull a patient’s longitudinal record from across disconnected providers through national data networks — powerful for care coordination, risk adjustment, and onboarding, but only as good as the integration around it. Identity resolution, FHIR data mapping, and resilient retrieval all take real engineering. Taction Software implements and integrates Particle Health for health-tech vendors: clinical data retrieval workflows, FHIR R4 mapping, patient identity resolution, and production operations. We are your integration partner for Particle, not Particle itself. For neighboring options, see our Redox and 1upHealth integration practices. Schedule a Particle Health Implementation Strategy Call → (NDA-protected) FHIR specialist team · clinical data aggregation experience · HIPAA + BAA When Particle Health Is the Right Choice Clinical Data Aggregation Use Cases Particle is a strong fit when you need to assemble a patient’s records from many sources you are not directly connected to, via national networks. Member Onboarding With Historical Records When onboarding a member or patient and you want their historical clinical record from the start, network-based retrieval brings it in without per-provider integration. Care Coordination Across Disconnected Providers For coordinating care across providers who do not share an EHR, Particle’s network reach surfaces records that would otherwise be invisible. Specialty Use Cases vs. Redox or 1upHealth Particle’s niche is network-based record retrieval, which is different from Redox‘s broad EHR connectivity or 1upHealth‘s FHIR data platform. The right tool follows your use case, and some stacks combine more than one. Our Particle Implementation Capabilities Clinical Data Retrieval Workflows We build the query, retrieval, and processing workflows that turn Particle responses into usable clinical data in your product. FHIR R4 Data Model Mapping We map retrieved data into your FHIR R4 model so it fits cleanly with the rest of your system — on our FHIR API development foundation. Patient Identity Resolution We implement demographic matching and identity resolution so retrieved records are correctly associated with the right patient. Error Handling & Retry Logic We build robust error handling, retry, and partial-result handling so network variability does not break your workflow. Particle vs Alternatives Particle vs Redox (Different Use Cases) Redox focuses on broad EHR connectivity and interface management; Particle focuses on retrieving records across networks. They solve different problems and can be complementary. Particle vs 1upHealth 1upHealth centers on a FHIR data platform and payer/aggregation use cases; Particle centers on network-based record retrieval. The choice follows your data model and where the records live. Particle vs Direct EHR Integration Direct integration gives deep, specific access to a known EHR; Particle gives broad reach across many providers without per-EHR builds. Depth versus breadth, as with most integration decisions. Common Use Cases We build care coordination apps, risk-adjustment workflows (pulling records to support compliant HCC capture, complementing our value-based care work), prior-authorization documentation (gathering supporting records, see our prior authorization automation work), and provider onboarding workflows. Implementation Approach Use Case Validation We validate the use case and confirm Particle is the right fit. Particle Sandbox Implementation We build and validate against Particle’s sandbox. Production Deployment We deploy to production with the identity, mapping, and error handling in place. Monitoring & Operations We build monitoring and support operations so retrieval stays healthy at scale. Engagement Options We work in three common shapes: an initial Particle implementation, a migration to or from another aggregator, and Particle optimization and scaling — all on our custom healthcare software foundation. Schedule a Particle Health Implementation Strategy Call → Frequently Asked Questions Particle vs other clinical aggregators? Particle’s strength is network-based retrieval of records across many disconnected providers, where Redox emphasizes EHR connectivity and 1upHealth emphasizes a FHIR data platform. The right choice depends on whether your problem is reaching many providers, integrating specific EHRs, or managing FHIR data — and we help you match tool to use case rather than defaulting to one. Performance at scale? Network-based retrieval performance depends on the networks and the volume of queries, so we architect with appropriate concurrency, caching of retrieved data, and asynchronous patterns, and we monitor it in production so it holds up as your volume grows. Data freshness? Network-retrieved records reflect what participating sources have shared, so freshness varies by source. We design workflows that account for that — for example, retrieving on a schedule or on demand at the right moments — so your product uses appropriately current data. Integration with our existing FHIR architecture? We map Particle data into your existing FHIR R4 model and resources so it integrates with the rest of your system rather than sitting in a silo, consistent with our data security and HIPAA-compliant development practices. Schedule a Particle Health Implementation Strategy Call → Reviewed by Taction Software’s healthcare integration engineering team. ISO 27001-certified information security management. We are an independent integration partner. PHI is handled under a signed BAA.

If your customers run Cerner — now Oracle Health — building a clean, listed integration is the way to reach them, and it takes Cerner-specific SMART on FHIR and API engineering to do well. Cerner’s developer program, Cerner Code (the Cerner Open Developer Experience, CODE), sits under Oracle Health today, and its direction is evolving with Oracle’s investment. Taction Software builds Cerner-integrated apps end to end: SMART on FHIR development, Cerner FHIR API integration, the Cerner-specific patterns, and support through marketplace listing. As with any EHR, the roles matter: we are your development partner for Cerner-integrated apps, not Oracle Health. Listing and program terms are set by Oracle Health and require your own program relationship — we build the software and help you navigate the process. For the platform comparison, see our Epic vs Cerner vs athenahealth page and Cerner vs Epic article. Schedule a Cerner / Oracle Health Integration Strategy Call → (NDA-protected) Cerner / Oracle Health integration experience · FHIR specialist team · SMART on FHIR expertise · HIPAA + BAA Cerner Code in the Oracle Era What’s Changed Post-Acquisition Since Oracle acquired Cerner, the developer program and platform have continued under Oracle Health, with Oracle’s resources and roadmap now shaping their evolution. Cerner Code Platform Evolution The Cerner Code / Open Developer Experience continues to provide the APIs and sandbox for building Cerner-integrated apps, and the branding and tooling are evolving under Oracle Health. Oracle Health Strategy Direction Oracle has signaled significant investment in the platform, and some buyers weigh the evolving roadmap as part of their decision — a real but not inherently negative consideration we help you think through. Our Cerner Integration Capabilities SMART on FHIR for Cerner EHR-launched apps, patient-launched apps, and Cerner-specific extensions on the SMART on FHIR standard — on our FHIR API development foundation. Cerner FHIR API Integration USCDI resource coverage, Cerner-specific resources, and bulk data so your app reads and writes what it needs through Cerner’s FHIR APIs. Cerner Open Engine Integration HL7 v2 integration (via our HL7 practice), CCL reporting (Cerner Command Language), and mPages integration for the clinician workflow. Marketplace & Distribution Support through Cerner Code listing, Oracle Health marketplace inclusion, and the strategic partnership path — preparing the technical artifacts and working with you through the process. Common Use Cases We Build We build clinical decision support apps (see our clinical decision support work), patient engagement apps (via our patient portal practice), analytics apps (via our healthcare data analytics work), and specialty workflow apps — all on our custom healthcare software foundation. Development Process Sandbox Access & Setup We set up against Cerner’s sandbox and developer environment. FHIR Resource Mapping We map your data model to Cerner’s FHIR resources and APIs. Integration Testing We test the integration thoroughly against Cerner’s environment. Marketplace Submission We prepare and support the marketplace submission for listing. Combined Cerner + Epic Strategy Many vendors need both. We design a multi-EHR app architecture that reuses logic across EHRs on a shared SMART on FHIR core, with EHR-specific customization layered on top — so you build once and adapt per platform rather than building twice. See our Epic App Orchard / Connection Hub work for the Epic side. Schedule a Cerner / Oracle Health Integration Strategy Call → Frequently Asked Questions How does Cerner Code differ from Epic App Orchard? Both are EHR developer programs built around SMART on FHIR, but they differ in APIs, tooling, listing process, and program terms, and Cerner’s now sits under Oracle Health. The good news is that a well-architected SMART on FHIR app shares a large common core across both; we handle the platform-specific differences. Oracle acquisition impact on developer program? The program continues under Oracle Health with Oracle’s backing, and the tooling and branding are evolving. For most vendors the practical impact is that you build to the current Oracle Health developer platform and stay attentive to roadmap changes — which we help you track. Multi-EHR strategy? We architect a shared SMART on FHIR core that maximizes reuse across Cerner, Epic, and other FHIR-capable EHRs, then add per-EHR customization. That keeps your engineering investment efficient while still meeting each platform’s specifics and listing requirements. Distribution without marketplace listing? It is sometimes possible depending on the integration and the customer’s policies, but a marketplace listing eases procurement and trust for Cerner-using customers. We help you decide between listing and a direct integration based on your go-to-market and target accounts. Schedule a Cerner / Oracle Health Integration Strategy Call → Reviewed by Taction Software’s healthcare integration engineering team. ISO 27001-certified information security management. We are an independent development partner, not Oracle Health; program and listing terms are set by Oracle Health. PHI is handled under a signed BAA — see our data security practice.

If your customers run Epic, building a clean, listed Epic integration is one of the most effective ways to reach and sell to them. Epic’s developer ecosystem — historically App Orchard, now organized as Connection Hub with the Showroom marketplace — is the channel, and getting an app through it takes real SMART on FHIR and Epic-specific engineering. Taction Software builds Epic-integrated apps end to end: SMART on FHIR development, Epic FHIR API integration, the Epic-specific patterns, and support through submission and listing. To be clear about roles: we are your development partner for Epic-integrated apps, not Epic. Listing, certification decisions, and program terms are Epic’s, and they require your own Epic program relationship — we build the software and help you navigate the process. For Epic integration more broadly, see our Epic EHR integration practice and Epic integration guide. Schedule an Epic App Strategy Workshop (Free 60-Min) → (NDA-protected) Epic integration experience · FHIR specialist team · SMART on FHIR expertise · HIPAA + BAA Why Epic Marketplace Distribution Matters Reach Epic’s Large Patient Base Epic holds records for a very large share of US patients — Epic has cited figures in the hundreds of millions — so a listed Epic app reaches an enormous installed base through one channel. Streamlined Health System Procurement A listed, pre-vetted app is far easier for an Epic-using health system to evaluate and buy than an unknown integration, shortening procurement. Pre-Approved Integration Pattern Building to Epic’s supported integration patterns means you are working within an approved, repeatable model rather than fighting the EHR. Our Epic Development Capabilities SMART on FHIR App Development EHR-launched apps, patient-launched apps, and standalone apps built on the SMART on FHIR standard — on our FHIR API development foundation. Epic FHIR API Integration USCDI resource coverage, Epic-specific resources, and bulk data export so your app reads and writes the data it needs through Epic’s APIs. App Submission & Certification Support through App Orchard submission, Connection Hub listing, and Showroom inclusion — preparing the technical artifacts and working with you through Epic’s process. Epic-Specific Integration Patterns Hyperspace embedded apps (in the clinician workflow), MyChart integration (patient-facing, via our patient portal work), and Care Everywhere integration for record exchange. Epic Marketplace Tiers & Strategy We help you choose the right route — App Orchard Direct, Connection Hub, Showroom / Workshop, or open-API listed — based on your product, customers, and the relationship you want with Epic. The naming has evolved, and we keep you oriented to the current structure. Common Use Cases We Build We build clinical decision support apps (see our clinical decision support work), patient engagement apps, care coordination apps, specialty practice apps, and AI/ML integration apps (via our healthcare AI work) — all on our custom healthcare software foundation. Epic App Development Process Use Case Validation We validate the use case and the integration approach before building. Sandbox Development We build against Epic’s sandbox / on-FHIR test resources. Testing Environment Certification We move through Epic’s testing-environment validation toward certification. Pilot Customer Validation We validate with a real Epic-using pilot customer to prove fit before broad release. Marketplace Submission We prepare and support the marketplace submission for Connection Hub / Showroom listing. Timeline & Investment Typical ranges, with the listing timeline also dependent on Epic’s process: We give a firmer estimate of the development scope after the strategy workshop. Schedule an Epic App Strategy Workshop (Free 60-Min) → Frequently Asked Questions Difference between App Orchard / Connection Hub / Showroom? They are stages of the same evolving ecosystem. App Orchard was Epic’s original developer program and marketplace; Epic has reorganized this into Connection Hub (the developer program and listing) with Showroom as the marketplace customers browse. The terms still circulate together, so we keep you aligned to Epic’s current structure and choose the right route for your product. Epic certification cost? Epic sets its own program fees and terms, and they depend on your arrangement and tier — we do not control or quote them, and you will establish them directly with Epic. What we scope is the development cost to build and ready your app; the Epic program costs are separate and confirmed with Epic. Can we sell without Epic listing? Sometimes, depending on the integration and the customer’s policies, but a listing materially eases procurement and trust for Epic-using customers and is often expected. We help you weigh listing against a direct integration based on your go-to-market. Multi-EHR strategy? Building to SMART on FHIR gives you a strong foundation that extends beyond Epic to other FHIR-capable EHRs, so we architect for portability where a multi-EHR strategy matters, then handle the Epic-specific layer for the Epic channel. Schedule an Epic App Strategy Workshop (Free 60-Min) → Reviewed by Taction Software’s healthcare integration engineering team. ISO 27001-certified information security management. We are an independent development partner, not Epic; Epic sets program and listing terms. PHI is handled under a signed BAA — see our data security practice.

HHS has set out cybersecurity expectations for healthcare in its Healthcare and Public Health Cybersecurity Performance Goals — a set of Essential and Enhanced goals that increasingly define what “good enough” security looks like for hospitals and health systems. They are voluntary today, but the direction of travel is toward mandatory minimums with potential Medicare implications, which makes getting ahead of them a smart move now. Taction Software helps you implement the technical controls behind the CPGs and produce the assessment, roadmap, and documentation to demonstrate where you stand. We provide the security engineering and assessment; the regulatory determination of what applies to your organization rests with your compliance and security leadership, with whom we work. For broader assessment work, see our healthcare security audit and HIPAA risk assessment practices. Schedule a CPG Compliance Assessment (Free 60-Min) → (NDA-protected) Healthcare cybersecurity specialists · NIST CSF expertise · HIPAA Security Rule program experience · ISO 27001-certified What HHS CPGs Require Essential Goals A baseline set of practices every healthcare organization is expected to have — the fundamentals that block the most common attacks. Enhanced Goals A more advanced tier for organizations maturing beyond the baseline toward stronger resilience. Voluntary vs. Mandatory Pathway The CPGs are currently voluntary guidance. HHS has signaled intent to move toward mandatory minimum requirements, and has proposed strengthening the HIPAA Security Rule, so treating the CPGs as a preview of future obligations is prudent. Your compliance team confirms what currently binds you. Medicare Reimbursement Implications There have been proposals to tie healthcare cybersecurity requirements to Medicare participation. These are evolving rather than settled, so we help you prepare for the trajectory without overstating what is in force today. Essential Goals We Implement Mitigate Known Vulnerabilities Patch management and vulnerability scanning so known weaknesses are found and closed on a cadence — complementing our penetration testing work. Implement Phishing Defense Email security controls and support for user training, since phishing remains the top entry point. Strong Authentication MFA implementation and privileged access management so credentials alone do not open the door. Asset Inventory & Network Segmentation Asset management and network-segmentation architecture so you know what you have and a breach cannot move freely — drawing on our data security practice. Enhanced Goals We Implement For organizations going further: advanced identity management, cyber resilience and recovery (backup, recovery, and tested incident response), third-party risk management, and building a cybersecurity mindset and skills across the organization. Our CPG Compliance Methodology Current-State Assessment We assess your existing security posture against the CPG practices. Gap Analysis Against CPGs We identify exactly where you fall short of the Essential and Enhanced goals. Implementation Roadmap We build a prioritized roadmap, sequencing the highest-risk gaps first. Engineering Work to Close Gaps We do the technical work — segmentation, MFA/PAM, patching and scanning programs, logging, recovery — to close the gaps, drawing on our software modernization and security practices. Documentation & Reporting We produce the documentation that demonstrates your posture for leadership, boards, and any future attestation. Combined CPG + Other Compliance The CPGs overlap with frameworks you may already maintain, and we map controls across them to avoid duplicate work: CPGs + the HIPAA Security Rule (see our HIPAA consulting and HIPAA-compliant development practices) and CPGs + NIST CSF, plus any other frameworks your organization holds. Medicare & Funding Implications We help you weigh the hospital reimbursement impact as requirements evolve, the benefits of voluntary adoption now (real risk reduction and readiness for whatever becomes mandatory), and the enforcement trajectory — without treating proposals as settled law. The honest summary: the bar is rising, and early movers carry less risk. Schedule a CPG Compliance Assessment (Free 60-Min) → Frequently Asked Questions Are CPGs mandatory yet? As of now they are voluntary guidance. HHS has signaled a move toward mandatory minimum requirements and has proposed strengthening the HIPAA Security Rule, with potential ties to Medicare under discussion. So they are not universally mandatory today, but the trajectory points toward enforcement — which is why preparing now is the low-risk choice. Confirm your current obligations with your compliance team. Cost of compliance? It depends entirely on your current maturity. An organization with solid security may have modest gaps; one starting further back has more to do. We assess first and give a roadmap with scoped cost, so you invest against real gaps rather than a generic checklist. HIPAA Security Rule sufficiency? Meeting the HIPAA Security Rule does not automatically satisfy all the CPGs. The Security Rule is risk-based and flexible, while the CPGs are more specific and prescriptive, and the proposed Security Rule update would raise the bar further. We map where your HIPAA program already covers CPGs and where additional work is needed. Reporting requirements? Formal reporting expectations are still taking shape as the requirements evolve. We build the documentation and evidence now so that whatever attestation or reporting is ultimately required, you can produce it without scrambling. Schedule a CPG Compliance Assessment (Free 60-Min) → Reviewed by Taction Software’s healthcare security engineering team. ISO 27001-certified information security management. We provide security engineering and assessment; regulatory determinations rest with your compliance leadership. PHI is handled under a signed BAA.

If your software diagnoses, treats, or drives clinical decisions, it may be a regulated medical device — and the FDA pathway is expensive, multi-year, and unforgiving of shortcuts. Taction Software builds Software as a Medical Device to the engineering standard the FDA expects: a quality-managed design-controls process, IEC 62304 software lifecycle, ISO 14971 risk management, premarket cybersecurity, and the verification, validation, and documentation that support a submission — including AI/ML SaMD with a Predetermined Change Control Plan. One thing to be clear about: we are your software engineering partner for regulated development, not an FDA regulatory consultancy or law firm. We build the compliant software and engineering evidence; your regulatory strategy and the FDA submission are led by you and your regulatory advisors, with whom we work closely. For decision-support products specifically, see our clinical decision support practice. Schedule an FDA SaMD Pathway Strategy Workshop (Free 60-Min) → (NDA-protected) Regulated-software engineering specialists · ISO 13485 QMS experience · IEC 62304 lifecycle · healthcare engineering credentials When Your Software Triggers FDA Regulation Definition of SaMD Software as a Medical Device is software intended for a medical purpose that performs that purpose without being part of a hardware device. Intended use is what determines it. Clinical Decision Support Carve-Out (Cures Act §3060) Some clinical decision support is excluded from device regulation when it meets the statutory non-device CDS criteria — including that the clinician can independently review the basis for the recommendation. Whether your CDS qualifies is a determination to confirm with your regulatory advisors; we design with the distinction in mind. Wellness vs. Medical Device General-wellness software intended to maintain a healthy lifestyle generally falls outside device regulation, while software making medical claims does not. The line is in the intended use and claims. Class I, II, III Determination Devices are classified by risk — Class I (low), II (moderate), III (high) — which drives the pathway and the evidence required. FDA Pathways We Support 510(k) Premarket Notification Predicate device strategy, substantial-equivalence documentation, and support through the FDA review process for devices that can demonstrate equivalence to a legally marketed predicate. De Novo Pathway For a novel device without a predicate, with risk-based classification and special controls for low-to-moderate-risk innovations. PMA (Premarket Approval) For Class III devices, the most rigorous pathway, typically with clinical-trial requirements and the strongest evidence burden. AI/ML SaMD With PCCP A Predetermined Change Control Plan, continuous-learning model management, and real-world performance monitoring so AI/ML devices can evolve within a pre-authorized envelope rather than re-submitting for every change — built on our healthcare AI work. Our FDA SaMD Engineering Methodology Quality Management System (ISO 13485 / QMSR) We engineer within a quality management system aligned to ISO 13485, consistent with the FDA’s Quality Management System Regulation (QMSR), which harmonized 21 CFR 820 with ISO 13485 effective February 2026. Design Controls (21 CFR 820) We follow design controls — inputs, outputs, reviews, verification, validation, and a design history file — as the backbone of regulated development. Software Lifecycle (IEC 62304) We develop to IEC 62304, the medical-device software lifecycle standard, with the rigor scaled to your software’s safety classification. Risk Management (ISO 14971) We apply ISO 14971 risk management throughout, so hazards are identified, controlled, and traced. Cybersecurity (FDA Premarket Cybersecurity Guidance) We build to FDA premarket cybersecurity expectations (including the “cyber device” requirements under FD&C Act §524B), with an SBOM and security testing — drawing on our penetration testing and security audit practices. AI/ML-Specific FDA Considerations We handle the AI/ML specifics: PCCP authoring, the choice between a locked algorithm and continuous learning, the algorithm change protocol that defines permitted changes, and real-world performance monitoring — the framework that lets an AI device improve safely within FDA’s expectations. Cost & Timeline These are typical industry ranges and vary widely by device, evidence needs, and pathway; the regulatory fees, regulatory-consultant, and clinical-trial costs are separate from our engineering scope: We give a firmer estimate of the engineering scope after the pathway workshop. Combined FDA + HIPAA + Quality Management FDA, HIPAA, and quality-management obligations overlap, and a stacked compliance strategy with shared documentation and audit crosswalks avoids doing the same work three times — connecting to our HIPAA-compliant development and data security practices. Schedule an FDA SaMD Pathway Strategy Workshop (Free 60-Min) → Frequently Asked Questions Does our product require FDA clearance? It depends on intended use and claims. Software with a medical purpose generally is regulated; general-wellness software and CDS that meets the Cures Act non-device criteria generally are not. This is a determination to confirm with your regulatory advisors — we help you understand where your product likely sits and design accordingly, but the regulatory call is theirs. 510(k) vs De Novo decision? If a suitable predicate device exists, 510(k) via substantial equivalence is usually faster; if your device is genuinely novel with no predicate, De Novo is the route for low-to-moderate risk. We help frame the engineering and evidence for either, and your regulatory advisors confirm the strategy. AI/ML continuous learning approval path? The current approach is a Predetermined Change Control Plan: you define, up front, the changes the model may undergo and how they will be validated and monitored, so the device can update within that authorized envelope. We author the PCCP engineering and build the monitoring; the submission strategy is led with your regulatory advisors. Pre-Submission meeting strategy? An FDA Pre-Submission (Q-Sub) is a valuable way to align with the FDA on your pathway, predicate, and evidence before you invest fully. We prepare the technical and engineering content that supports a strong Pre-Sub, working alongside your regulatory team who manage the FDA interaction. Schedule an FDA SaMD Pathway Strategy Workshop (Free 60-Min) → Reviewed by Taction Software’s regulated-software engineering team. ISO 27001-certified information security management. We provide regulated-software engineering and documentation, not regulatory or legal services; FDA strategy and submission are led with your regulatory advisors. PHI is handled under a signed BAA.

The information blocking rule has changed the default in healthcare from “share when required” to “share unless an exception applies” — and getting it wrong now carries real penalties. The hard part is rarely wanting to comply; it is operationalizing the rule, applying the eight exceptions correctly, and documenting the decisions. Taction Software provides the technical and workflow side of information blocking compliance: practice discovery, exception-framework implementation, technical access and API design, and the documentation tooling that supports your compliance posture. An important boundary: information blocking is a legal and regulatory matter, and this is implementation support, not legal advice. We work alongside your compliance team and counsel, who make the legal determinations. For the broader context, see our overview of 21st Century Cures Act compliance. Schedule an Info Blocking Compliance Assessment (Free 45-Min) → (NDA-protected) Healthcare regulatory implementation experience · ONC rule specialist team · HIPAA + BAA What the Info Blocking Rule Prohibits Definition of “Information Blocking” Broadly, a practice by a regulated actor that is likely to interfere with the access, exchange, or use of electronic health information (EHI), except as required by law or covered by an exception. Who Is Subject (Actors Defined) Three actor types: health care providers, health IT developers of certified health IT, and health information networks and exchanges (HINs/HIEs). Penalty Framework Health IT developers, HINs, and HIEs can face OIG civil monetary penalties of up to $1 million per violation. Health care providers are subject to separate “disincentives” established by a later rule (tied to federal program participation rather than CMPs). The specifics of how these apply to you are a legal determination for your counsel. The 8 Exceptions The rule defines eight exceptions in two groups. We help you implement the technical and workflow conditions each requires; whether a given practice qualifies is a legal call. Exceptions for Not Fulfilling a Request (5) Exceptions for the Manner of Fulfilling a Request (3) Our Info Blocking Compliance Approach Practice Discovery & Gap Assessment We inventory your data-sharing practices and identify where information blocking risk exists. Exception Framework Implementation We implement the technical and operational conditions your relied-upon exceptions require. Policy & Procedure Development We help develop the supporting policies and procedures, in coordination with your compliance team and counsel. Technical Workflow Design We design the access, API, and request-handling workflows so sharing is the default and exceptions are applied deliberately — built on our FHIR API development work. Training & Documentation We build the documentation and support the training so decisions are recorded and defensible. Info Blocking for Different Actors Healthcare Providers Providers must make EHI available and handle access requests without practices that interfere — with the right exceptions applied. Related: our ONC certification and CMS interoperability work. Health IT Developers Developers of certified health IT must not design or operate products in ways that block information, and must support standardized access (e.g., APIs). HIEs / HINs Networks and exchanges must not impose practices that interfere with exchange across their participants. Common Practices That Trigger Info Blocking Concern The recurring risk areas: data access fees that do not meet the Fees exception, information withholding without a valid exception, API throttling that impedes access, and onerous patient workflows that effectively block patient access. We assess each against the rule. Enforcement & Penalty Risk Enforcement is active. Developers, HINs, and HIEs face OIG civil monetary penalties (up to $1 million per violation), and providers face disincentives under the separate provider rule. Enforcement actions have begun under these frameworks; rather than cite specific cases that may be mischaracterized, we focus on reducing your risk to the point where enforcement is not a concern. Your counsel advises on legal exposure. Frequently Asked Questions Can we still charge for some data access? Sometimes. The Fees exception permits certain fees that meet its conditions, but it does not cover things that must be provided without special charge, such as a patient’s access to their own EHI. Whether a specific fee qualifies is a legal determination; we build the workflows and documentation to support fees that your counsel confirms are permissible. What about competitor data requests? The rule is specifically concerned with anti-competitive withholding, so declining a legitimate request simply because the requester is a competitor is risky. The Licensing and Content-and-Manner exceptions govern how you may respond on reasonable terms. We implement compliant request-handling; the legal line on a given request is for your counsel. Documentation requirements? Documentation is central, because exception reliance has to be demonstrable. We build the tooling to record your practices, the exceptions relied upon, and the basis for decisions, so you can show your reasoning if questioned. How to handle patient consent? Patient access to their own EHI generally must be fulfilled, while the Privacy exception governs situations where law or required consent applies. We build consent and access workflows consistent with that, in line with our data security and HIPAA-compliant development practices, with your counsel confirming the legal treatment. Schedule an Info Blocking Compliance Assessment (Free 45-Min) → Reviewed by Taction Software’s healthcare regulatory implementation team. ISO 27001-certified information security management. This is technical and workflow implementation support, not legal advice; legal determinations rest with your compliance team and counsel. PHI is handled under a signed BAA.

The CMS interoperability rules are not one deadline — they are a cascade. The 2020 Interoperability and Patient Access Final Rule put the Patient Access and Provider Directory APIs in place, and the 2024 Interoperability and Prior Authorization Final Rule expands them and adds new APIs with key requirements effective in 2027. For payers, the question is no longer whether to comply but how to do it without scrambling at each deadline. Taction Software builds the FHIR APIs the rules require — Patient Access, Provider Directory, Payer-to-Payer, and Prior Authorization — and helps you sequence the work against the dates. We provide the technical implementation; the regulatory determination of your obligations remains yours and your compliance team’s. For the broader payer stack, see our payer software development practice. Schedule a CMS Compliance Assessment (Free 60-Min) → (NDA-protected) FHIR & Da Vinci specialist team · payer-tech credentials · HIPAA + BAA · CMS rule implementation expertise CMS Interoperability Rule Requirements Timeline Patient Access API (Effective 2021) Required since 2021 under the Patient Access Final Rule, letting members retrieve their data through third-party apps — and expanded by the 2024 rule to include prior-authorization information. Provider Directory API Also required since 2021, exposing a public-facing, current provider directory via FHIR. Payer-to-Payer Data Exchange The 2024 Prior Authorization Final Rule establishes a FHIR-based payer-to-payer API, with the requirement effective in 2027, so member data follows them between plans. Prior Authorization API (Effective 2027) The 2024 rule’s Prior Authorization API (and the related Provider Access API) carry requirements effective in 2027, with certain decision-timeframe and reporting provisions phasing in starting 2026 — see our prior authorization automation and utilization management work. Compliance Requirements by API Patient Access API (CARIN BB) Built to the CARIN Blue Button guide, exposing claims and encounter data, clinical data, cost and out-of-pocket information, and provider directory — on our FHIR API development foundation. Provider Directory API (Da Vinci PDex) A FHIR R4 provider directory with real-time updates and a public-facing endpoint, built to the relevant Da Vinci guide. Payer-to-Payer Data Exchange Member onboarding data, historical claims and clinical data, and a member-initiated workflow so a member’s history transfers when they change plans. Prior Authorization API Da Vinci PA implementation — CRD, DTR, and PAS — with a provider submission workflow that fits the EHR. Penalty & Enforcement Risk Non-compliance carries real consequences. CMS can publicly report non-compliant plans, and enforcement can include compliance actions and, depending on program, monetary and operational penalties; for Medicare Advantage, interoperability performance ties into broader oversight. Rather than quote specific figures, we focus on getting you compliant ahead of the dates so enforcement risk never materializes. Our Compliance Methodology Gap Assessment We assess your current state against each API requirement and the applicable deadlines. FHIR Service Implementation We stand up or extend the FHIR services the APIs require. Da Vinci Profile Implementation We implement the CARIN and Da Vinci profiles each API is built to. Member Identity & Authentication We implement member identity and the authorization model (including SMART/OAuth patterns) so access is secure and standards-based. Operational Compliance Documentation We produce the operational and attestation documentation that demonstrates compliance. Combined CMS + Cures Act Strategy The CMS and ONC/Cures Act requirements overlap, and treating them as one program saves money: overlapping requirements are addressed once, on shared FHIR infrastructure, with an audit and documentation crosswalk that maps controls across both — see our overview of 21st Century Cures Act compliance. Timeline & Investment We work to a per-API compliance timeline, give you a total compliance investment estimate scoped to your environment, and recommend a phased approach that hits each deadline in priority order rather than attempting everything at once. Schedule a CMS Compliance Assessment (Free 60-Min) → Frequently Asked Questions What if we miss the PA API 2027 deadline? Missing it exposes you to CMS enforcement and the reputational and operational consequences of public non-compliance reporting, on top of the provider and member friction the API was meant to relieve. The practical answer is to start now — the 2027 requirements are knowable today, and a phased plan makes the deadline very achievable if you begin early. Can we use 1upHealth / vendor for compliance? Yes. Platforms like 1upHealth can accelerate compliance significantly, and we implement on them where they fit. We help you decide between a platform, custom build, or hybrid, then implement and document it — the platform provides capability, but correct implementation and attestation are still required. Bulk data API requirements? The rules leverage FHIR Bulk Data (Flat FHIR) for efficient exchange of large data sets, and we implement the Bulk Data API where the requirements and your use cases call for it, alongside the per-member access APIs. Member consent management? Member access and payer-to-payer exchange are member-authorized, so consent and authorization management are central. We build the consent capture, authorization, and access-control workflows so data moves only when the member has approved it, consistent with our data security and HIPAA-compliant development practices. Schedule a CMS Compliance Assessment (Free 60-Min) → Reviewed by Taction Software’s payer technology and FHIR engineering team. ISO 27001-certified information security management. We provide technical implementation; regulatory determinations remain with your compliance team. PHI is handled under a signed BAA.

No-shows hit a practice in three places at once — lost revenue, wasted provider capacity, and broken continuity of care — and most practices lose a significant share of their schedule to them. Software can recover much of that by predicting which appointments are at risk, engaging patients the way they actually respond, removing the barriers that cause no-shows, and filling the gaps when they happen anyway. Taction Software builds AI-powered no-show prediction and reduction — risk scoring, smart multi-channel engagement, barrier removal, and intelligent rescheduling — integrated with your EHR and practice-management system. Schedule a No-Show Reduction Strategy Call (Free 30-Min) → (NDA-protected) Patient engagement experience · AI/ML credentials · HIPAA + BAA · multi-channel messaging expertise The Cost of No-Shows Average Revenue Lost Per No-Show Every no-show is a slot that cannot be re-sold once the day passes — direct lost revenue that compounds across a year. We model your specific per-no-show cost rather than quoting a generic figure. Capacity Utilization Impact No-shows quietly erode capacity utilization, so you are paying for provider time that produces nothing. Recovering even part of it is high-margin. Provider Productivity Effect Gaps in the schedule fragment provider time and frustrate clinicians, which has its own downstream cost. Patient Care Continuity Impact Beyond finances, a no-show is a missed care opportunity — a gap in follow-up or chronic-care management that can harm outcomes. Software Capabilities That Reduce No-Shows AI No-Show Prediction Risk scoring for each appointment, high-risk patient identification, and risk-informed predictive overbooking — built on our healthcare data analytics and healthcare AI work. Overbooking is applied carefully, using risk scores to recover capacity without creating waiting-room chaos. Smart Patient Engagement Multi-channel reminders (SMS, email, voice, push), personalized reminder timing, and two-way confirmation workflows — built on our healthcare CRM, patient portal, and mobile app practices, with patient consent and messaging compliance built in. Barrier Removal Transportation coordination, childcare and schedule-conflict identification, and SDoH-aware outreach that addresses why patients actually miss appointments — helping patients keep their care, not profiling them. Smart Rescheduling Cancellation-triggered outreach to a waitlist, same-day slot filling, and provider schedule optimization so an opening becomes a filled slot instead of lost time. ROI of No-Show Reduction The math is straightforward and CFO-friendly: revenue capture from slots that would have gone empty, capacity recovery across the schedule, and provider productivity lift. We build the ROI model on your no-show rate and visit volume so the projection is yours, not an average. Implementation Approaches We work in three common shapes: a standalone no-show platform, an EHR-integrated module, and a patient-engagement platform add-on — all on our custom healthcare software foundation. Industry Sub-Segments We Serve We build for primary care, specialty practices, behavioral health (which sees especially high no-show rates — see our behavioral health software work), FQHCs and safety-net clinics (where barrier removal matters most), and multi-site DSOs (see our multi-site practice software work). Integration With EHR & Practice Management No-show software has to act on the schedule: Epic, Cerner, athenahealth, and eClinicalWorks integration via our Epic integration and HL7 practices, practice-management integration, and patient-portal integration — built on our FHIR foundation. For some visit types, a virtual option via telemedicine is itself a no-show mitigation. Schedule a No-Show Reduction Strategy Call (Free 30-Min) → Frequently Asked Questions Typical no-show reduction achieved? It depends on your starting no-show rate, specialty, and patient population — behavioral health and safety-net settings start higher and have more room, while a well-run primary care practice has less. Rather than promise a fixed percentage, we baseline your rate and model a realistic reduction for your situation. How does AI prediction work? The model learns from patterns in historical appointment data — factors like prior no-show history, appointment type, lead time, and timing — to score each upcoming appointment’s risk. High-risk appointments then get more intensive engagement and inform careful overbooking. It is a probability estimate that targets effort, not a judgment about any individual. Privacy considerations? Patient messaging involves PHI and is governed by HIPAA, and outreach by phone and text is subject to consent rules such as TCPA. We build with patient consent and opt-in, channel preferences, and HIPAA-compliant messaging so engagement is both effective and compliant — see our data security and HIPAA-compliant development practices. SDoH-aware outreach approach? We identify and help address the social barriers behind no-shows — transportation, childcare, and schedule conflicts — and tailor outreach accordingly, for example coordinating transportation for at-risk patients. The goal is to help patients keep appointments they want to keep, applied to support access rather than to label or exclude anyone. Schedule a No-Show Reduction Strategy Call (Free 30-Min) → Reviewed by Taction Software’s healthcare AI and patient-engagement engineering team. ISO 27001-certified information security management. PHI is handled under a signed BAA, and patient outreach is built with consent and messaging compliance.

Clinical documentation quality sits underneath almost everything that matters in a health system — accurate DRG and severity assignment, quality-measure capture, revenue integrity, and audit defensibility. Clinical Documentation Improvement is how you get there, and AI is rapidly changing what CDI can do. Taction Software builds AI-augmented CDI software — concurrent and retrospective review, suspect-condition identification, compliant provider queries, and CDI analytics — for hospitals, health systems, and RCM companies. AI surfaces opportunities and drafts queries; CDI specialists and clinicians make the calls. CDI is about improving the documentation; coding is about assigning the codes that documentation supports. For the coding side, see our AI medical coding work and our AI coding and CDI with LLMs article. Schedule a CDI Software Strategy Workshop → (NDA-protected) CDI domain expertise · AI/NLP credentials · HIPAA + BAA · healthcare AI specialist team Why CDI Matters Specificity Impact on DRG / APR-DRG Assignment Documentation specificity directly drives DRG and APR-DRG assignment and severity capture (CC/MCC). When documentation is vague, the record understates acuity and the assignment is wrong. Quality Measure Capture Many quality measures depend on what is documented. Incomplete documentation means missed quality capture, which carries its own consequences under value-based programs. Revenue Integrity CDI is a revenue-integrity discipline: capturing the acuity that was actually treated, compliantly — not upcoding, but accurate representation. Compliance & Audit Risk Reduction Strong, specific documentation is the best audit defense. CDI reduces the risk that codes cannot be supported when a payer or auditor asks — see our data security and compliance practices. CDI Software Capabilities Concurrent CDI Real-time documentation review during the stay, specificity querying, and provider education in workflow so gaps are closed while the patient is still in-house. AI-Powered CDI LLM-based documentation analysis, suspect-condition identification, and auto-generated provider queries — built on our clinical NLP and healthcare RAG work. Queries are compliant and non-leading; the AI proposes, the CDI specialist reviews, and the provider exercises clinical judgment. Retrospective CDI Pre-billing review, post-discharge documentation improvement, and audit defense for the records that need a second look before the claim goes out. CDI Analytics Provider-level CDI performance, service-line CDI metrics, and severity and risk capture, built on our healthcare data analytics work. CDI for Different Settings We build for inpatient CDI, outpatient / profee CDI, risk-adjustment CDI (HCC) (complementing our value-based care work, done compliantly so captured conditions are documentation-supported), and combined inpatient + outpatient programs. Integration With EHR & RCM CDI has to live in the workflow: EHR integration (Epic, Cerner, athenahealth) via our Epic integration and HL7 practices, CDI worklist generation, and a provider query workflow that fits how clinicians actually work — built on our FHIR foundation. Build vs Buy for CDI Buying Existing CDI Tools (3M/Solventum, Nuance, Optum) Incumbent CDI platforms are mature and a strong fit for many organizations. If one covers your needs, buying is often the right call. Building Custom CDI Custom makes sense when incumbents do not fit your specialties, your AI ambitions, or your integration needs, or when you want to own the capability. Hybrid Approach Often the answer is hybrid — keep a strong incumbent and build custom AI or analytics around it. We help you decide objectively; see our custom vs off-the-shelf framework. ROI of AI-Augmented CDI The returns to measure: DRG capture improvement, HCC capture improvement, reduced audit risk, and CDI specialist productivity (AI handling the first pass so specialists focus on judgment). We model these on your data rather than quoting generic figures. Schedule a CDI Software Strategy Workshop → Frequently Asked Questions AI CDI vs. traditional CDI tools? Traditional CDI tools rely heavily on rules and prioritization; AI CDI uses LLMs and NLP to read the full record, surface suspect conditions, and draft compliant queries with more nuance. The strongest programs combine them — AI for breadth and first-pass analysis, specialists for judgment. How accurate is AI for clinical documentation analysis? Accuracy varies by record type and specialty, so we benchmark on your data against expert CDI review rather than quoting a headline number. Critically, AI here is a suggestion engine — it flags opportunities and drafts non-leading queries that CDI specialists validate and clinicians decide on, so accuracy is backstopped by human review. Integration with our EHR? Yes. We integrate CDI with Epic, Cerner, and athenahealth — generating worklists, surfacing opportunities, and routing provider queries within the EHR workflow so CDI is part of the work, not a separate system. Build vs buy? It depends on how well an incumbent fits. If a 3M/Solventum, Nuance, or Optum tool covers your needs, buying is often right; custom or hybrid wins when they fall short on your specialties, AI goals, or integration. We give you an honest read and can build the custom or AI layer where it adds value. Schedule a CDI Software Strategy Workshop → Reviewed by Taction Software’s healthcare AI and clinical documentation engineering team. ISO 27001-certified information security management. PHI is handled under a signed BAA — see our HIPAA-compliant development practice. See our broader healthcare AI solutions.