Compliance in Innovation-Driven Projects

A viral image of an ATM in Ludhiana recently caught my attention - a dangerously steep ramp ending abruptly at a glass door, with a staircase running alongside that leads nowhere. A perfect reminder of a hard-earned lesson in fintech: "Compliance isn’t just a checkbox." Product Managers: You don't want to miss saving 💾 this post for your future reference. This ramp was technically "compliant" - yes, there was a wheelchair access ramp. But it completely missed the purpose of accessibility. People had angry comments on social media about the apathy with which wheelchair-bound customers were treated and how the bank had made a mockery of accessibility. No amount of regulation can account for 'compliance as a checkbox' implementations that are designed to meet the regulation but not serve their intended purpose. It's the same trap I've seen countless fintech products fall into - implementing regulations as mere checkboxes rather than embracing them as design principles. I've experienced regulatory hurdles umpteen times in product launches; in fact, I've never experienced a straightforward implementation that hasn't hit a regulatory roadblock. BUT I can say this confidently: Compliance-first design is the secret sauce that makes the battle easier and less arduous, and inarguably 'faster' IF You just stick to the first principles of building this into your product strategy from day one . Regulations can either slow you down or become your competitive edge. To make compliance your strategic advantage, here's my 3-step playbook: 1/ Design Integration: Make regulatory adherence a natural part of the user experience rather than an afterthought ↳Embed compliance requirements into your initial product design ↳Get feedback from legal and compliance teams, and even the regulator if needed ↳Validate, Test, Iterate, Repeat 2/ Cross-Functional Collaboration: Build bridges between product, legal/compliance teams from day one ↳Involve them early ↳Make compliance & legal stakeholders brainstorm and provide feedback ↳Balance innovation with regulatory requirements using case studies and data to back up assertions instead of getting into crosshairs with them 3/ Validate Early, Validate Often: ↳Test with real scenarios ↳Get early feedback from regulators ↳Regular compliance assessments, no matter what stage of development you are in One golden tip - document everything, err on the side of caution when it comes to building and fostering trust with legal and compliance counterparts. The lesson in one line? Build WITH compliance, not around it. Instead of working around regulations, let's build with them. Because when you design within the right guardrails, innovation doesn't just survive—it scales. What's your strategy for managing fintech compliance? Share below. 👍 LIKE this post, 🔄 REPOST this to your network and follow me, Monica Jasuja

Europe just CE marked its first LLM-powered medical device. Prof. Valmed, a clinical decision-support system built on a retrieval-augmented generation (RAG) architecture, has been certified as a Class IIb medical device under EU MDR (2017/745). That classification places it in the same risk category as infusion pumps and ventilators meaning it requires Notified Body review, a full ISO 13485 quality management system, software lifecycle documentation under IEC 62304, and a robust post-market surveillance plan. This is a notable precedent for generative AI in clinical care. For those of us building regulated healthtech products, a few takeaways: --RAG architectures are viable, but only with traceability, curation, and grounding. Prof. Valmed queried over 2.5 million validated sources and preserved retrieval paths, prompt logic, and model state for auditability. --Evidence requirements are tightening. Generic model benchmarks won’t cut it. The review demanded indication-specific performance data, bias mitigation strategies, and plans for continuous monitoring. --Dual-framework compliance is the new norm. The EU AI Act adds layers of transparency, human oversight, and data governance to what MDR already requires. The FDA’s PCCP guidance is converging in similar ways. Teams will need harmonized documentation across all three. --Enterprise buyers and payers are factoring in compliance maturity. Cost-effectiveness, audit trails, and fairness metrics are making their way into procurement criteria, especially for clinical AI. If you’re an early-stage team, this is less about racing to certification and more about structuring your product, data, and validation strategy with these expectations in mind. Compliance isn't the goal, it’s the baseline for clinical credibility and long-term defensibility. Happy to compare notes if you're navigating MDR, the AI Act, or FDA alignment. https://lnkd.in/g7rkk97b

After reviewing hundreds of regulatory submissions at Complear, I've uncovered a shocking pattern that's costing the MedTech industry millions! 𝟖𝟎% 𝐨𝐟 𝐦𝐞𝐝𝐭𝐞𝐜𝐡 𝐬𝐭𝐚𝐫𝐭𝐮𝐩𝐬 𝐦𝐚𝐤𝐞 𝐭𝐡𝐞 𝐞𝐱𝐚𝐜𝐭 𝐬𝐚𝐦𝐞 𝐜𝐫𝐢𝐭𝐢𝐜𝐚𝐥 𝐦𝐢𝐬𝐭𝐚𝐤𝐞 in their first FDA or CE marking application: they focus obsessively on perfecting their technology while treating regulatory strategy as a checkbox to tick later. The consequences? Devastating delays that can kill promising companies: - Brilliant AI-powered diagnostic tools delayed by 18+ months - Funding rounds missed due to extended timelines - Competitive advantages lost to better-prepared competitors - Technical debt accumulated from retrofitting compliance Here's what separates the winners from the casualties: ❌ 𝐅𝐚𝐢𝐥𝐢𝐧𝐠 𝐂𝐨𝐦𝐩𝐚𝐧𝐢𝐞𝐬: Build first, regulate later - Develop features without considering regulatory pathways - Scramble to create documentation post-development - Face costly redesigns to meet compliance requirements - Burn through runway during extended review periods ✅ 𝐒𝐮𝐜𝐜𝐞𝐬𝐬𝐟𝐮𝐥 𝐂𝐨𝐦𝐩𝐚𝐧𝐢𝐞𝐬: Integrate regulatory thinking from day one - Map regulatory requirements before writing code - Design clinical validation into product development - Build Quality Management Systems alongside technology - Treat regulators as partners, not obstacles The reality is harsh: regulation isn't a hurdle to overcome after innovation—it IS part of innovation in healthcare. The FDA and Notified Bodies aren't just checking boxes; they're ensuring your brilliant technology actually helps patients safely. At Complear, we've seen this transformation happen when startups shift their mindset from "regulation vs. innovation" to "regulation-driven innovation." The companies that grasp this early don't just survive regulatory review—they thrive because of it. 𝐓𝐡𝐞 𝐪𝐮𝐞𝐬𝐭𝐢𝐨𝐧 𝐢𝐬𝐧'𝐭 𝐰𝐡𝐞𝐭𝐡𝐞𝐫 𝐲𝐨𝐮'𝐥𝐥 𝐟𝐚𝐜𝐞 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐜𝐡𝐚𝐥𝐥𝐞𝐧𝐠𝐞𝐬—𝐢𝐭'𝐬 𝐰𝐡𝐞𝐭𝐡𝐞𝐫 𝐲𝐨𝐮'𝐥𝐥 𝐛𝐞 𝐩𝐫𝐞𝐩𝐚𝐫𝐞𝐝 𝐟𝐨𝐫 𝐭𝐡𝐞𝐦. Are you building your regulatory strategy alongside your technology, or are you setting yourself up for an 18-month delay? #MedTech #Regulation #FDA #CEMarking #AIinHealthcare #MedicalDevices #RegulatoryStrategy

“Compliance-first” isn’t code for “Innovation-last” There’s a silent panic that ripples through every fintech startup the moment the CCO joins a product meeting: “Well, there goes the fun.” Suddenly, words like “real-time,” “automated,” & “permissionless” turn into “wait for legal,” “check the rulebook,” & “what does the license say?” Here’s the truth no one wants to admit: Too many fintech CEOs treat compliance like a necessary evil. Like it’s there to slow them down instead of scale them right. But the great ones? They weaponize it. 🤝 Innovation & compliance aren’t opposites—they’re dance partners Let’s kill the myth once & for all: "Compliance-first" doesn’t mean innovation-last. 👉 It means building smart, not just fast. 📊 A report by Deloitte found that fintechs that integrated compliance early in product development had a 32% faster time-to-market when launching in new regions, compared to those who treated compliance as an afterthought. In other words: 👉 Compliance done early = fewer surprises, fewer pivots, fewer regulators knocking on your door with a cease-&-desist. 🧠 The real mindset shift: Compliance is design constraint, not design killer Think about it. Airbags didn’t stop car innovation. They made it trustworthy. Seatbelts didn’t kill speed. They made speed sustainable. The same is true for fintech. 👉 Your compliance framework should shape innovation, not shut it down. & great CEOs know that a product that isn’t compliant at scale… isn’t a product—it’s a liability with a landing page. 💡 How great Fintech CEOs actually handle it 1. They bring compliance into the room early—not post-launch If your compliance officer is seeing the product for the first time in the beta release, you're not leading—you're gambling. Great CEOs create co-creation between product, tech, & legal. Because alignment early saves reinvention later. 2. They hire compliance leaders who get business—not just risk You're not looking for a regulator-in-residence. You're looking for someone who understands growth, product velocity, & how to say “yes, and” instead of just “no.” 🧠 According to EY, the fastest growing fintechs have compliance leads that sit in executive meetings, not just audit reviews. Translation: strategic compliance, not reactive policing. 3. They build trust into the brand—& turn it into a moat Compliance is a GTM advantage if you position it right. Most customers in fintech want to know you're regulated, secure, & playing by the rules. 4. They set the tone: compliance isn’t the brakes—it’s the guardrail Great CEOs don’t tolerate a culture where people roll their eyes when Legal joins the call. They make it clear: "We innovate inside the lines—& we win because of it." 🧭 Bottom line: 🧪 You’re not building a hackathon project. 🏗️ You’re building financial infrastructure. & in fintech, the fastest way to win… 👉 is to build like you belong. #Fintech #Compliance #Regulation #Leadership #FinancialServices

AI regulation is no longer theoretical. The EU AI Act is a law. And compliance isn’t just a legal concern but it’s an organizational challenge. The new white paper from appliedAI, AI Act Governance: Best Practices for Implementing the EU AI Act, shows how companies can move from policy confusion to execution clarity, even before final standards arrive in 2026. The core idea: Don’t wait. Start building compliance infrastructure now. Three realities are driving urgency: → Final standards (CEN-CENELEC) won’t land until early 2026 → High-risk system requirements go into force by August 2026 → Most enterprises lack cross-functional processes to meet AI Act obligations today Enter the AI Act Governance Pyramid. The appliedAI framework breaks down compliance into three layers: 1. Orchestration: Define policy, align legal and business functions, own regulatory strategy 2. Integration: Embed controls and templates into your MLOps stack 3. Execution: Build AI systems with technical evidence and audit-ready documentation This structure doesn’t just support legal compliance. It gives product, infra, and ML teams a shared language to manage AI risk in production environments. Key insights from the paper: → Maps every major AI Act article to real engineering workflows → Aligns obligations with ISO/IEC standards including 42001, 38507, 24027, and others → Includes implementation examples for data governance, transparency, human oversight, and post-market monitoring → Proposes best practices for general purpose AI models and high-risk applications, even without final guidance This whitepaper is less about policy and more about operations. It’s a blueprint for how to scale responsible AI at the system level across legal, infra, and dev. The deeper shift. Most AI governance efforts today live in docs, not systems. The EU AI Act flips that. You now need: • Templates that live in MLOps pipelines • Quality gates that align with Articles 8–27 • Observability for compliance reporting • Playbooks for fine-tuning or modifying GPAI models The whitepaper makes one thing clear: AI governance is moving from theory to infrastructure. From policy PDFs to CICD pipelines. From legal language to version-controlled enforcement. The companies that win won’t be those with the biggest compliance teams. They’ll be the ones who treat governance as code and deploy it accordingly. #AIAct #AIGovernance #ResponsibleAI #MLops #AICompliance #ISO42001 #AIInfrastructure #EUAIAct

Compliance done right transforms hurdles into frameworks for innovation and trust. Many in the development space view compliance with a certain level of animosity. Transforming compliance stakeholders from passive approvers to active participants represents a significant opportunity for organizations to accelerate innovation while maintaining regulatory integrity. By having compliance teams shoulder their own requirements rather than burdening innovators, organizations can unleash creative potential while improving compliance outcomes. This approach requires thoughtful organizational design, cultural transformation, and strategic implementation, but the benefits in terms of innovation acceleration and competitive advantage are substantial. The evidence from various industries suggests that this integration is not only possible but increasingly necessary in complex regulatory environments. Organizations that successfully implement this approach gain both speed and compliance advantages over competitors who maintain traditional siloed structures. As regulatory requirements continue to evolve and increase in complexity, the ability to integrate compliance considerations seamlessly into innovation processes will become an even more critical organizational capability. Doing this well isn’t easy. It requires leadership commitment, progressive implementation strategies, technology enablement, and clear accountability frameworks. By taking these steps, organizations can transform the relationship between compliance and innovation from one of tension to one of synergistic collaboration, ultimately delivering better products to market faster while maintaining regulatory excellence.

Regulations often feel like barriers. The best product teams know how to turn them into opportunities. As product counsel, you can help your team leverage compliance as a competitive advantage. Here’s how to make regulations work for you: Position Compliance as a Feature: "GDPR compliance isn’t just a requirement—it’s how we keep your data safe." Use this in marketing to build trust. Use Standards to Enter Markets: Regulations like PSD2 or FDA approval create high barriers to entry—turn them into your unique selling point. Exceed Baseline Requirements: Go beyond accessibility or environmental laws to deliver exceptional experiences for underserved markets. Spot Trends Before They’re Mandates: Proactively align with emerging regulations (like AI transparency laws) to position your product as a leader. Collaborate With Regulators: Build relationships and advocate for smart policies that align with your product’s goals. When you approach regulations intentionally and creatively, you don’t just follow the rules—you lead the market. What’s your favorite example of turning compliance into innovation? -------- 💥 I’m Olga V. Mack 🔺 Expert in AI & transformative tech for product counseling 🔺 Upskilling human capital for digital transformation 🔺 Leading change management in legal innovation & operations 🔺 Keynote speaker on the intersection of business, law, & tech 🔝 Let’s connect 🔝 Subscribe to Notes to My (Legal) Self newsletter

"It's a Regulatory Requirement..." But Is It Really the End of the Conversation? One phrase I keep hearing in project steercos and strategy meetings, especially when we’re trying to reengineer a process or roll out innovation, is this: “It’s a regulatory requirement !!!”. Like a Danger sign… That line tends to land like a full stop. A shutdown. No further questions. And honestly? It riles me up every time. Because more often than not, the regulation being cited was written a decade ago, long before the type of innovation we’re discussing even existed. Yet it’s presented as though it were handed down on stone tablets. Immutable. Absolute. But that’s not what progressive thinking looks like. People who are resistant to change often hide behind regulations. And while regulations are indeed important, meant to protect people, systems, and institutions, they were created by humans like us, with the information, technology, and the issues that existed back then. Those variables with the knowledge, assumptions, and technologies are evolving, so should the regulations. That means they are not immune to interpretation, context, or evolution. So, here’s a better way to approach it: What is this regulation trying to prevent? What is the principle behind it? Can we address that concern in a smarter, more effective way? How can we comply and deliver the best customer experience while also reducing cost and increasing efficiency? A forward-thinking mindset doesn’t hide behind regulation. It engages with it. It understands the intent. It builds solutions that both align with and innovate. Then collaborate with the regulators. Sometimes, when you’re truly ahead of the curve, you may even find yourself showing the regulator a better path forward. Some organisations are being disrupted simply because they keep saying, “It's regulatory!” while others progressively engage with the regulator for a win-win. Let’s stop using regulation as a shield for inertia. Let’s start using it as a platform for intelligent engagement and innovation. Because compliance, at its best, doesn’t stifle innovation, it enables it. Like I have said before, AI and tech will not replace people… But managers who use these tools will replace those who don’t.

💡 Are Compliance Standards Killing Innovation, or Are We Framing Them Wrong?💡 Compliance standards are often viewed as barriers to creativity, especially in fields like artificial intelligence (AI). But frameworks like ISO42001 are not obstacles as much as they are enablers. They provide the structure needed to innovate responsibly, ensuring organizations can offer accountability, trust, and scalability. For leaders implementing an Artificial Intelligence Management System (AIMS), conformance to the standard can help establish a foundation for trustworthy AI systems, reducing risks and enabling sustainable innovation that also aligns with the OECD.AI’s Principles. ➡️ How ISO42001 Drives AI Innovation 1. Clarity Creates Confidence 🔹 Challenge: Teams hesitate to deploy AI when risks like bias or privacy breaches remain unresolved. 🔹ISO42001 Solution: Establishes clear processes for risk management, documentation, and decision traceability. 🔸Impact: Developers can innovate confidently within a framework that reduces uncertainty. 2. Risk Management Enables Bold Ideas 🔹Challenge: AI development involves unpredictable outcomes and operational risks. 🔹ISO42001 Solution: Provides structured tools to identify, mitigate, and monitor risks throughout the AI lifecycle. 🔸Impact: Teams can pursue ambitious ideas with safeguards in place, balancing creativity with accountability. 3. Accountability Builds Trust 🔹Challenge: Stakeholders demand transparency and fairness in AI decision-making. 🔹ISO42001 Solution: Embeds accountability mechanisms, ensuring decisions are traceable and ethical. 🔸Impact: Encourages collaboration and risk-taking, knowing ethical considerations are part of the process. 4. Collaboration Fuels Innovation 🔹Challenge: Innovation often stalls when teams operate in silos. 🔹ISO42001 Solution: Defines clear roles and responsibilities, enabling cross-functional alignment. 🔸Impact: Teams work together more effectively, addressing risks early and accelerating progress. ➡️ AIMS as a Platform for Innovation ISO42001 creates the environment where AI innovation thrives. By integrating ethical considerations, risk management, and lifecycle monitoring, you can scale your AI solutions responsibly while fostering creativity. 🔹Example: AIMS ensures challenges like bias or transparency are proactively addressed, allowing developers to focus on building impactful AI systems. 🔸Long-term Value: Innovations are not just scalable but also aligned with societal and organizational goals. ➡️ Rethinking Compliance Governance/Management frameworks like ISO42001 are not roadblocks, they are opportunities. They establish trust, reduce uncertainty, and provide the structure you need to innovate responsibly. 🔸Key Takeaway: Success in AI isn’t defined by how quickly systems are built, but by how effectively they deliver ethical, sustainable value. A-LIGN #TheBusinessofCompliance #ComplianceAlignedtoYou ISO/IEC Artificial Intelligence (AI)

“𝗕𝘂𝗶𝗹𝘁 𝘁𝗵𝗲 𝗺𝗼𝗱𝗲𝗹. 𝗦𝗵𝗶𝗽𝗽𝗲𝗱 𝘁𝗵𝗲 𝗳𝗲𝗮𝘁𝘂𝗿𝗲. 𝗦𝗸𝗶𝗽𝗽𝗲𝗱 𝘁𝗵𝗲 𝗴𝗼𝘃𝗲𝗿𝗻𝗮𝗻𝗰𝗲.” Welcome to the part where innovation outpaces accountability...again. What we’re calling “compliance” is no longer about checkboxes. It’s about consequence. A missed audit isn’t just a fine, it’s a breach of trust. A biased model isn’t just bad data, it’s brand damage Unmonitored agent isn’t just automation, it’s liability. This is the moment where AI governance shifts from being the legal team’s job to becoming everyone’s job. Trianz's latest report gives you the blueprint, not for AI growth, but for AI integrity. If you care about leading tech that people can trust, start here. 🔸Key #AIGovernance Domains ➝Manage consent+user choices. ➝Automate privacy+vendor checks. ➝Govern data use and AI behavior. 🔸3-Step #AICompliance Automation ▪️Step 1: Scope Risk ➝Map systems, data, and laws. ➝Use tools for quick alignment. ▪️Step 2: Set Policies ➝Auto-generate and sync controls. ➝Apply versioning+updates. ▪️Step 3: Assess & Act ➝Score risks, link to detection tools. ➝Trigger fixes directly in workflows. 🔸Implementing AI Lifecycle Compliance ▪️Phase 1: Planning ➝Conduct PIAs, define risk scope. ▪️Phase 2: Design ➝Ensure privacy by design, audit fairness. ▪️Phase 3: Development ➝Use anonymized+synthetic data. ▪️Phase 4: Deployment ➝Build audit trails+version control. ▪️Phase 5: Monitoring ➝Track model drift+bias re-evaluations. 🔸Operationalizing Compliance ➝Encrypt data, apply zero trust. ➝Automate consent+DSARs. ➝Trace data flow, block attacks. 🔸Data Lifecycle Management ➝Use tools like Macie, Collibra. ➝Minimize data, anonymize with k-tech. ➝Track flows with Apache Atlas. 🔸Security & Integrity ➝Encrypt with AES-256, TLS 1.3. ➝Use Zero Trust+MFA. ➝Monitor via IDS+audit logs. 🔸Consent & Rights ➝Automate opt-ins ➝ Process DSARs via CRM. ➝ Log consents with secure records. 🔸AI Tool Governance ➝Block unvetted tools. ➝Add human oversight. ➝A/B test outputs. 🔸Compliance Readiness ➝Track models and legal status. ➝Assess risks, enable audit logs. ➝Simulate threats, maintain inventory. 🔸Implementation Roadmap ➝Short-Term: Map data, train teams. ➝Mid-Term: Align ops, update vendors. ➝Long-Term: Scale ethics+audits. 🔸Business Benefits ➝Avoid fines, reduce tech debt. ➝Build trust, boost brand equity. ➝Certify early to stand out as AI ready. 🔸Key Metrics ➝% Compliant models ➝Incident rates ➝Human oversight time ➝Trust scores+fairness ratings ➝Innovation vs industry peers 🔸Takeaways ➝Monitor #AI in real time. ➝Spot hidden risks early. ➝Adapt to new rules fast. Bottomline Organizations must embed governance into every layer of AI before risk becomes reality. Hr. Dr. Takahisa Karita |Dr. Ram Kumar G,|Vikram Pandya| Carthic Kameshwaran|Rajesh Dangi| Sarvex Jatasra |L Venkata Subramaniam| Marcos Allende López |Sam Greenblatt|Dr. Sunil Kr Pandey|John Riley III| Prasanna Lohar