Report Highlights

Oncology Information Systems in the U.S.: Market Overview

The U.S. oncology information systems market was valued at USD 1.42 billion in 2024 and is forecast to reach USD 2.61 billion by 2032. It comprises radiation oncology platforms such as Varian ARIA and Elekta MOSAIQ, chemotherapy ordering and treatment planning modules, and tumor registry software. The market took its present shape through regulation: the HITECH Act of 2009 funded general electronic health record adoption, which left oncology-specific workflow as a specialist layer bolted onto hospital systems.

Government has been the dominant force in demand formation. The Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare and Medicaid Services (CMS) set the certification and reimbursement rules that determine which products hospitals buy. Private companies led product innovation: Flatiron Health, owned by Roche, built a real-world oncology data layer, while Tempus AI and Syapse developed precision oncology analytics without federal product funding. Academic cancer centers and hospital systems remain the largest purchasers.

Policy-Driven Growth in U.S. Oncology Information Systems

Three mechanisms drive demand. First, the HITECH Act of 2009 created the Medicare EHR Incentive Program, now administered as the Promoting Interoperability Program under CMS, which requires eligible hospitals to report certified EHR measures each year or face downward payment adjustments. Oncology departments within these hospitals must therefore run certified electronic systems that capture treatment data in structured form, converting a compliance obligation into a recurring purchase.

Second, the 21st Century Cures Act appropriated USD 1.8 billion for the Cancer Moonshot over seven years, funding National Cancer Institute data-sharing initiatives that require oncology providers to supply structured registry data. Third, the CMS Enhancing Oncology Model, launched in July 2022 by the CMS Innovation Center, pays participating practices for care management and requires quarterly performance reporting. This links EHR data quality directly to practice revenue, which drives upgrades to oncology-specific platforms.

Regulatory Barriers and Compliance Costs

ONC's Health IT Certification Program, established under the 21st Century Cures Act, requires oncology modules to meet certification criteria in 45 CFR Part 170 before they can be sold to providers receiving federal funding. Certification testing and recertification typically add 12 to 18 months to product release cycles, and vendors bear the cost of supporting USCDI data elements in every certified module.

The FDA regulates treatment planning and dose calculation software as medical devices under 21 CFR Part 820, with the Quality Management System Regulation aligning with ISO 13485 from 2 February 2026. Vendors such as Varian and Elekta must secure 510(k) clearance for software changes affecting dose calculation, a process that adds months to release timelines. HIPAA Security Rule compliance, enforced by the HHS Office for Civil Rights, adds further audit costs for cloud-hosted platforms.

Policy-Created Opportunities in the U.S.

The Enhancing Oncology Model creates demand for data abstraction and quarterly reporting tools that extract treatment and toxicity data from EHRs. Participating practices need certified platforms that export structured data, opening a niche for vendors offering pre-built EOM measure reporting modules. This opportunity persists until the model's scheduled end in 2028.

The Inflation Reduction Act of 2022 introduced Medicare drug price negotiation, with negotiated prices for the first ten drugs taking effect on 1 January 2026, including ibrutinib (Imbruvica). Manufacturers now require real-world outcome data to model the financial impact, creating demand for analytics from Flatiron Health and Tempus AI. Separately, the Trusted Exchange Framework and Common Agreement (TEFCA), authorized under the 21st Century Cures Act, lets oncology providers exchange records through Qualified Health Information Networks, favoring vendors with QHIN-compatible connectors.

Market at a Glance

Leading Market Participants

• Epic Systems
• Oracle Health
• Varian Medical Systems
• Elekta
• Flatiron Health
• Ontada
• Tempus AI
• Syapse
• IMPAC Medical Systems
• Oncora Medical

Regulatory and Policy Environment

The primary legislation is the 21st Century Cures Act (Public Law 114-255, 2016), administered by ONC, which mandates the Health IT Certification Program and prohibits information blocking. ONC's final rule "Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing" (HTI-1, published January 2024) requires certified developers to disclose source attributes for predictive decision support interventions and mandates USCDI version 3 adoption by 1 January 2026. Enforcement of HIPAA (Public Law 104-191) rests with the HHS Office for Civil Rights, and HITECH (Public Law 111-5) sets breach notification and EHR incentive rules.

Compared with the European Union, which is building the European Health Data Space under Regulation (EU) 2025/327 and classifies oncology planning software under the Medical Device Regulation (EU) 2017/745, the U.S. framework is market-led. It relies on certification and information-blocking enforcement rather than mandated data-sharing infrastructure. Upcoming changes include the HHS proposed HIPAA Security Rule update published in January 2025, which would make encryption and multi-factor authentication mandatory, and the FDA QMSR effective 2 February 2026.

Long-Term Policy Outlook for U.S. Oncology Information Systems

The CMS Innovation Center is expected to announce a successor oncology payment model before the Enhancing Oncology Model ends in 2028. That successor will likely tie payment to quality reporting, forcing practices to upgrade to certified FHIR APIs and pushing spending toward platforms with built-in measure calculation.

A finalized HIPAA Security Rule will raise the cost of cloud hosting and favor vendors holding HITRUST certification. Expanded TEFCA participation will reduce bespoke interface spending and shift share toward vendors with national exchange connectivity, including Epic Systems and Oracle Health, while specialist radiation oncology vendors defend their position through device-integrated workflows.