Article 8 min read Oleksandr Andrieiev, CEO & Co-founder Enterprise Risk Management Framework: How to Build and Implement It Business • Engineering • Healthcare • Financial Services • IT Strategy & Consulting • Software Development • CEO ERM considers financial, operational, and compliance risks as a whole rather than distinct issues at the level of departments, and integrates the risk management process into strategic decisions. Two frameworks guide almost all risk management processes: the COSO ERM framework (consists of five elements and is used by North American boards) and ISO 31000 (flexible principles framework). The process itself is based on four phases no matter what framework is selected: identify risks, evaluate their probability and consequences, determine response, and monitor continuously. Only 15% of ERM leaders report being very confident in the organization’s ability to detect and predict risks before they arise. But companies that operate with a mature enterprise risk management process observe declines in losses from operations, regulation, and incident resolution expenses. The gap between acknowledging that risk and managing it is where the real damage occurs, and in regulated industries, including fintech software development and healthcare, it can be costly. Enterprise risk management treats the three types of risk (financial, operational, and compliance) as a single entity across the business, rather than as isolated threats belonging to different departments. The process starts by choosing between the COSO and ISO 31000 frameworks, then repeats the four-stage cycle of identifying, assessing, planning responses, and monitoring, regardless of which framework is selected. Key Takeaways: ERM is a continuous, organization-wide process that replaces siloed risk handling with a unified view across the entire enterprise. Companies in fintech and healthcare pay twice for the absence of ERM: first to the regulator, then during the operational recovery that follows an incident. A mature ERM program does not eliminate risk. It makes it manageable and predictable enough to inform business decisions. ERM implementation starts not with technology but with assigning risk ownership at the C-suite level. What Is Enterprise Risk Management and Why Does It Matter for Enterprises? Enterprise risk management (ERM) is a strategic, organization-wide process for identifying, evaluating, and responding to risks that could affect a company’s ability to achieve its objectives, treating the organization as a single entity rather than a collection of departments. The key concept shared by both the COSO ERM Framework and the ISO 31000 standard is that risk management is efficient when integrated throughout the organization. Risk decisions must be linked to business strategy so that senior management understands what can happen and how much uncertainty they are willing to tolerate. In practice, 60% of organizations still rely on spreadsheets for ERM program management. That fragmentation is not just an efficiency problem. It is a strategic blind spot. Types of Enterprise Risk: What You Are Actually Managing Before building an ERM framework, leadership needs a clear view of the risk categories to which the organization is exposed. Operational Risk Operational risk arises from failures in internal processes, systems, or people. Operational risk management has become a priority as third-party involvement in breaches doubled from 15% to 30% in a single year. Strategic Risk Strategic risk refers to events that threaten the organization’s ability to achieve its objectives. ERM links the strategic risks to business planning, so leadership is not surprised by what should have been a known variable. Financial Risk Financial risk includes exposure to revenue loss, credit, liquidity, or market volatility. In regulated industries, it intersects directly with compliance risk when regulatory penalties affect capital. Compliance and Legal Risk This risk category includes the failure to comply with law, regulations, or contractual agreements. The cost of the risk is not just the financial penalty but also operational interruption and recovery costs. This is why proactive risk assessment healthcare teams must operate under HIPAA as a business priority. Hazard and Safety Risk Risks relating to physical, environmental, or safety concerns involving people also fall within the ERM scope. An all-inclusive enterprise risk management process covers these types of risk along with digital and financial risks. How to Build an ERM Framework That Works in Practice The regulatory requirements, which include DORA compliance for finance and HIPAA for healthcare, have become an integral component of the ERM framework, along with the internally established governance standards that companies traditionally follow. COSO ERM Framework Updated in 2017, the COSO ERM Framework integrates risk management with strategy and performance across five components: governance and culture; strategy and objective-setting; performance; review and revision; information, communication, and reporting. It is the standard most North American boards and audit committees build oversight around. ISO 31000 Risk Management Standard Overview ISO 31000 adopts a flexible framework based on general principles that can be applied in various industries and regulatory contexts. It functions as an adaptable guideline rather than a prescriptive model, making it easier to tailor to the organization’s specific risk context. COSO ERM Framework vs. ISO 31000 Both standards target one thing: managing risks in an organized manner. The differences lie in the level of structure and the groups of people that use them. COSO ERM Framework ISO 31000 Structure Five defined components: governance and culture, strategy and objective-setting, performance, review and revision, information/communication/reporting A set of general principles rather than a fixed model Best For Organizations that want risk management formally tied to strategy and performance measurement Organizations operating across multiple industries or regulatory environments that need to adapt their approach Flexibility Lower. Follows a fixed, prescriptive structure. Higher. Built as an adaptable guideline rather than a prescriptive model. Typical Adopters North American boards and audit committees Cross-industry, internationally operating organizations So which one fits your organization? Use COSO if your board or audit committee expects a defined structure to organize oversight around, particularly in North America.Use ISO 31000 if you operate across multiple industries or regulatory environments and need room to adapt as you go. Neither standard is objectively superior; the right choice comes down to how much structure you need versus how much flexibility you can’t do without. Core Components of an Enterprise Risk Management Process Regardless of which standard you build from, a functional risk management system includes the same foundational components. Risk identification begins with a structured inventory of every risk the organization faces, from the most severe to the most operational. This is not a one-time exercise. Risk identification needs to be ongoing because new risks emerge as the business changes. Risk assessment determines the likelihood and potential impact of each identified exposure. This is where the organization sets its risk appetite: the level of uncertainty it is willing to accept in pursuit of its objectives, and its tolerance, the outer boundary of acceptable variation. Risk response falls into four categories, and the choice among them should be deliberate and written down rather than left as a default: Avoid: stop the activity or exposure entirely when the risk outweighs any benefit it brings. Reduce: put controls in place that bring the likelihood or impact down to an acceptable level. Transfer: shift the financial consequence elsewhere, typically through insurance or contractual terms. Accept: take the risk knowingly, usually because addressing it would cost more than the exposure itself. Monitoring and communication sustain ERM throughout assessment intervals. As risks change, businesses must have proper reporting channels to make sure that decision makers get adequate information. Implementing a Risk Management Strategy: Where Organizations Get It Wrong The most frequent failure of ERM implementation lies more in its design than execution. An approach confined to the four walls of the Compliance department, with quarterly reporting that is rarely seen outside the function, is not ERM. It’s documentation. For a risk management strategy to be implemented effectively, there should be top-level commitment prior to choosing either a framework or a tool. There should be a Chief Risk Officer, or at least an equivalent figure, with the mandate to escalate risks and affect strategy. Otherwise, ERM will remain administrative. Across IT consulting engagements, firms having an effective ERM program always have two things in common: ownership at the executive level and a risk appetite statement that executives use. Both come before discussing technology. Steps That Work in Practice Getting ERM from a framework decision to a functioning program requires the same discipline that the program itself is meant to instill. 1. Start with scope Determine which risks the ERM program will address within the initial phase, the owners of each risk type, and how to escalate matters. A narrow scope leads to faster outcomes and makes the organization more confident about the whole process. 2. Tailor the framework to the business COSO and ISO 31000 provide structure, but they do not account for your organization’s specific regulatory environment, operating model, or risk profile. Enterprise risk management examples from peer organizations provide useful reference points, but direct copying rarely works because the risk context differs. 3. Build the communication infrastructure Risk data might not be effective unless it is communicated to the proper individuals at the right time. This involves establishing consistent reporting rhythms, determining what to escalate and what not to, and ensuring that risk reporting is reviewed by leaders. 4. Measure and iterate ERM is not a project with an end date. Set specific goals for what the program will deliver in the first 12 months, measure against them, and adjust. The programs that fail are the ones that launch with high ambition and no mechanism for tracking whether anything has changed. ERM in Regulated Industries: Fintech and Healthcare In regulated industries, the absence of a formal ERM program is itself a regulatory finding. The enterprise risk management examples below illustrate what that looks like in practice for fintech and healthcare organizations operating under active regulatory enforcement. Fintech Risk Management: Operating Under DORA and Basel III DORA came into force on January 17, 2025, and is applicable to 21 categories of financial institutions within the European Union. The regulation sets strict requirements for ICT risk management, incident reporting, resilience testing, and third-party risk oversight. Without formalized ERM, fintech software development organizations typically face exposure across three overlapping areas: cybersecurity and ICT failures, third-party vendor risk, and compliance failures during inspections. All three are operational risk management failures and, under DORA compliance, are reviewable by competent authorities. Non-compliance under DORA carries real financial weight, and the penalties stack in layers. The most serious violations can cost a financial institution up to 2% of annual worldwide turnover. Individual senior managers face personal liability of as much as €1 million when a violation traces back to their decisions. Critical ICT providers sit under their own penalty structure, with fines reaching €5 million. Fintech companies that undergo regulatory compliance without having ICT risk and incident management procedures documented show that operational resilience is absent from their business. Healthcare Risk Management: HIPAA, Data Breaches, and Operational Exposure HIPAA risk management entails an organization-wide risk analysis, which is a compliance requirement. The OCR enforcement action in 2025 was aimed at non-compliance when it came to risk analysis, the most common area of concern during breaches. ? Discover how AI finance automation accelerates monthly financial close by 10x and eliminates manual data extraction across multiple jurisdictions. Data breach costs averaged $4.44 million per incident in 2025, and 710 large breaches were reported to OCR that year. For healthcare software development organizations, vendor risk is not optional to manage. The majority of exposed records trace back to third-party business associates, not directly to providers. Benefits of the Enterprise Risk Management Process Beyond Compliance Companies with functioning ERM programs do not just avoid fines. They make better business decisions because they operate with more complete information. An effective enterprise risk management process allows for improved risk reporting through gathering information from all parts of the company into a report that is easily actionable by senior management. It eliminates the practice of receiving separate reports from various units that don’t match up because they cannot be reconciled. ERM results in lowering costs associated with managing risks in the long run. Firms that identify potential risks ahead of time end up spending much less to fix problems compared to entities that react to an incident only once it occurs. Companies with mature ERM programs also access capital more easily. Investors and lenders view a formalized risk management process as a signal of operational maturity, and in regulated industries, it directly affects the terms on which capital is available. Better data quality follows from better risk processes. ERM requires that risk data be captured systematically, which improves the underlying data infrastructure and produces information that is useful across the business, not just within the risk function. The Bottom Line: Turning Resilience into Strategy Implementing an Enterprise Risk Management framework is fundamentally a transition from a reactive defense to a proactive business strategy. As regulations like DORA and strict HIPAA oversight raise the financial and legal stakes for fintech and healthcare organizations, treating risk management as an isolated compliance task is no longer viable. Spreadsheets and siloed departmental processes simply cannot keep pace with today’s operational and third-party threat landscapes. A mature ERM program does not aim to eliminate every threat; instead, it provides senior leadership with the structured data, clear execution metrics, and cross-enterprise visibility needed to make high-stakes decisions with confidence. By standardizing risk metrics, defining clear executive ownership, and anchoring your strategy in established models like COSO or ISO 31000, you protect your capital and build a resilient foundation for long-term operational growth. Organizations recognize the importance of having a structured risk management program. However, few of them know how to structure one that holds up under a DORA audit or OCR investigation, and what controls actually matter for their industry. If you operate in fintech or healthcare and want to pressure-test your current risk posture before it becomes a problem, talk to Jelvix experts to see what an ERM readiness review looks like for your environment.