Flatiron Health: Oncology Data, Software, and Real-World Evidence

Flatiron Health is a healthcare technology company focused on one of the hardest problems in medicine: understanding and improving the real-world experience of people living with cancer. By combining oncology expertise, software, and advanced data science, Flatiron helps cancer centers, life science companies, and regulators learn from routine clinical care and turn those insights into better treatments and outcomes.

From Startup Vision to Global Oncology Partner

Founded in 2012 and later acquired by Roche, Flatiron has grown from a New York–based startup into a global player in oncology data and technology, with thousands of employees across the United States, Europe, and Asia. The company works with community oncology practices, academic cancer centers, regulators, and biopharma partners to bridge the long-standing gap between day-to-day patient care and clinical research.

While traditional clinical trials remain the gold standard for establishing efficacy and safety, most patients are treated outside of those trials. Flatiron’s core idea is to harness information from these real-world settings to complement trial data and help answer questions that matter to clinicians, regulators, payers, and—most importantly—patients.

What Flatiron Health Actually Does

Flatiron operates at the intersection of oncology, data, and software. Its business spans three broad domains that reinforce one another:

• Technology for cancer clinics that supports clinical workflows and captures high-quality electronic health record (EHR) data.
• Curated real-world oncology datasets that aggregate, de-identify, and structure data from millions of patient journeys.
• Evidence generation services that help biopharma and academic partners use that data for research, regulatory submissions, and health technology assessments.

Software for Oncologists and Cancer Centers

Many oncology practices face fragmented systems, manual documentation, and complex reimbursement rules. Flatiron provides cloud-based tools that aim to simplify clinical workflows while capturing detailed clinical information such as diagnoses, staging, treatments, and outcomes. These systems help:

• Oncologists coordinate treatment plans and track patient progress.
• Care teams manage scheduling, infusion chairs, and documentation.
• Billing staff handle complex oncology reimbursement requirements.

Because these tools are built for oncology from the ground up, they are designed to capture the disease-specific detail needed for both care and research—such as line of therapy, biomarker status, and progression events—which are often missing or inconsistently recorded in generic EHR systems.

Real-World Data from Routine Care

Flatiron aggregates de-identified, longitudinal data from a large network of oncology practices and cancer centers. These datasets can include:

• Demographics and baseline characteristics.
• Diagnoses, stage, and tumor type.
• Treatments received (chemotherapy, immunotherapy, targeted agents, radiation).
• Laboratory values, imaging reports, and select genomic test results.
• Clinical outcomes, such as response and survival.

At research partners such as the University of Colorado Cancer Center, Flatiron data covers millions of patients across over twenty tumor types and can be linked with next-generation sequencing results from external labs. These resources allow investigators to perform retrospective studies that would be infeasible to run as randomized trials, particularly in rare cancers or small molecularly defined subgroups.

Evidence Solutions for Biopharma and Regulators

Life science companies increasingly rely on real-world evidence (RWE) to complement randomized controlled trials. Flatiron’s evidence solutions are used to support activities across the drug development lifecycle, including:

• Understanding disease burden and treatment patterns.
• Designing clinical trials and identifying feasible endpoints.
• Estimating comparative effectiveness in real-world populations.
• Supporting regulatory submissions and health technology assessment (HTA) dossiers.

Flatiron has collaborated directly with regulators and HTA bodies such as the U.S. Food and Drug Administration (FDA) and the UK’s National Institute for Health and Care Excellence (NICE), helping explore how well-characterized real-world datasets can support decisions about oncology drugs. These collaborations align with broader regulatory efforts to define standards and best practices for RWE in decision-making.

How Flatiron Turns Raw Records into Reliable Evidence

Turning unstructured clinical notes, scanned documents, and ad hoc workflows into reliable research-grade data is a non-trivial challenge. Flatiron tackles this problem using a combination of technology, clinical expertise, and quality oversight.

Data Curation and Abstraction

While some data elements (like demographics or billing codes) can be extracted directly from EHR fields, key oncology variables often live in physician notes, pathology reports, or radiology impressions. Flatiron uses disease-specific abstraction protocols and trained clinical abstractors—often nurses or tumor registrars—to systematically review charts and extract relevant information in a standardized way.

This curated information is then harmonized using controlled vocabularies and consistent definitions, creating datasets that researchers and regulators can analyze with confidence. Flatiron documents its data quality processes and has engaged external partners to evaluate the fitness-for-use of its datasets in different contexts.

Machine Learning and Automation

In addition to manual curation, Flatiron employs machine learning models to scale data extraction and standardization. These models can help identify patterns in unstructured text, classify disease subtypes, or infer treatment lines from medication records and clinical notes. Automated tools are typically validated against human-curated references to reduce error and bias.

Privacy, Security, and Compliance

Because Flatiron works with sensitive health information, privacy and security are foundational. Clinical datasets used for research are de-identified in accordance with applicable regulations, and technical safeguards such as encryption and access controls protect data in transit and at rest. Tools like Flatiron Clinical Pipe, which move data between EHRs and electronic data capture (EDC) systems for clinical trials, are designed to comply with frameworks like HIPAA, GDPR, and FDA 21 CFR Part 11 for electronic records and signatures.

Improving the Clinical Trial Experience

One area where real-world data and workflow tools come together is in the conduct of clinical trials. Traditional trials often require duplicative data entry and manual reconciliation between EHRs and study systems, which can burden clinicians and slow research. Flatiron’s Clinical Pipe technology offers an EHR-to-EDC connector that automates much of this flow.

By mapping structured EHR data to trial forms and synchronizing updates, Clinical Pipe reduces transcription errors and monitoring queries while helping research sites focus on patient care and protocol adherence. This aligns with broader industry efforts to modernize clinical trial infrastructure using digital tools, as advocated by organizations like the FDA and academic medical centers.

A Mission-Driven Culture Focused on Patients

Flatiron’s internal culture is crafted around its oncology mission. Employees come from varied backgrounds—software engineering, data science, biostatistics, clinical oncology, nursing, design, operations—but share a common belief that better use of data can change the trajectory of cancer care.

Hybrid Work and Global Hubs

The company is headquartered in New York City and operates multiple hubs across North America, Europe, and Asia. These offices support a hybrid model in which teams blend in-person collaboration with remote work. Workspaces are designed to foster cross-functional interaction among engineers, clinicians, and business teams.

Benefits and Support for Employees

Because oncology work can be emotionally demanding, Flatiron emphasizes comprehensive benefits and well-being support. Examples include:

• Medical, dental, and vision coverage, along with health savings or spending accounts.
• Mental health resources and access to counseling or digital well-being tools.
• Flexible working hours and generous paid time off.
• Retirement savings plans with employer contributions.
• Parental leave policies and family-building benefits, including support for fertility, adoption, or surrogacy.

Employee Resource Groups and Inclusion

Diverse perspectives are central to understanding and serving a diverse cancer patient population. Flatiron supports a range of employee resource groups (ERGs) that provide community, mentorship, and advocacy for different identities and life experiences. These groups create spaces for:

• Women in technology and leadership.
• Black, Latinx, and Asian and Pacific Islander employees.
• LGBTQ+ staff seeking community and visibility.
• Employees with disabilities and their allies.
• Parents and caregivers balancing work and family responsibilities.

ERG activities range from internal talks and mentoring to community volunteering and partnerships with external organizations. This internal focus on equity and belonging parallels the company’s external mission of making cancer care more consistent and evidence-based across different populations.

Why Real-World Evidence Matters in Oncology

The push toward real-world evidence does not replace randomized trials but supplements them. Cancer therapies are increasingly targeted to specific biomarkers or rare subtypes, making it difficult to run large trials for every clinically relevant question. Real-world data helps fill these gaps by illuminating what happens when treatments are used in broader, more heterogeneous populations.

Regulators and academic researchers have recognized the value of such data when it is collected and analyzed rigorously. The FDA, for example, has issued guidance describing how real-world evidence can inform regulatory decisions for drugs and biologics when data quality and study design are appropriate. Health technology assessment agencies and payers similarly look to real-world outcomes to evaluate comparative effectiveness, cost-effectiveness, and value in routine care.

Impact on Researchers, Clinicians, and Patients

Flatiron’s work affects multiple stakeholders across the cancer ecosystem:

• Researchers gain access to large, clinically rich datasets for observational studies, hypothesis generation, and trial design.
• Clinicians benefit from oncology-specific software that can support documentation, decision-making, and participation in research.
• Biopharma sponsors use evidence solutions to design more efficient trials and generate supportive data for regulatory and reimbursement decisions.
• Regulators and HTA bodies receive analyses based on real-world use that complement trial evidence and inform policy.
• Patients may gain earlier access to promising therapies, more consistent care pathways, and, over time, treatments that better reflect the realities of their disease and circumstances.

Challenges and the Road Ahead

Despite progress, real-world data in oncology still faces challenges. EHR systems remain fragmented, documentation practices vary widely, and biases in who receives certain treatments can complicate analysis. Flatiron and similar organizations must continually improve data quality, representation, and methodology to ensure that conclusions drawn from real-world evidence are valid and equitable.

Future directions include deeper integration of genomic, imaging, and patient-reported outcomes; more seamless connectivity between trial systems and clinical care; and closer collaboration with academic and regulatory partners to standardize definitions and methods. As oncology becomes more personalized and complex, companies like Flatiron will likely play an expanding role in turning routine care into a learning system that benefits every patient.

Frequently Asked Questions About Flatiron Health

Q: Is Flatiron Health a hospital or a clinic?

A: No. Flatiron Health is not a hospital. It is a healthcare technology company that builds software, data, and analytics solutions for oncology providers, researchers, and life science companies.

Q: How does Flatiron get its data?

A: Flatiron partners with community oncology practices and academic cancer centers to obtain electronic health record data. This information is de-identified, curated, and standardized before being used for research and evidence generation.

Q: Who uses Flatiron’s real-world datasets?

A: Academic researchers, biopharma companies, and, in some cases, regulators and health technology assessment bodies use Flatiron datasets to study treatment patterns, outcomes, and comparative effectiveness in routine oncology care.

Q: How does Flatiron protect patient privacy?

A: Clinical data used for research are de-identified and handled in accordance with privacy regulations such as HIPAA and GDPR. Technical and organizational safeguards, including encryption and strict access controls, support data security.

Q: What kinds of roles work at Flatiron Health?

A: Flatiron employs software engineers, data scientists, statisticians, clinicians, nurses, product managers, designers, operations and business professionals, among others, all working together to improve cancer care through data and technology.

Written by

Medha Deb

Medha Deb is an editor with a master's degree in Applied Linguistics from the University of Hyderabad. She believes that her qualification has helped her develop a deep understanding of language and its application in various contexts. Medha specializes in the areas of beauty, health, sports, and wellness and is committed to ensuring that the content on the website is…