Trust erosion in MedTech ecosystem

HealthTech CEOs obsess over encryption. And ignore the real threat. Your HealthTech security budget isn't enough. Because the biggest threat isn't a hack; it's a breach of trust. In HealthTech, we talk a lot about firewalls, encryption, and compliance. We invest heavily to protect patient data from cyberattacks. But what happens when, despite all the technical safeguards, a breach occurs? The fallout extends far beyond the immediate financial cost or regulatory fines. The true devastation of a healthcare cyberattack is the erosion of patient trust. Patients feel betrayed. Their most sensitive information, the very essence of their health journey, has been exposed. This isn't just data; it's deeply personal. Clinicians become hesitant. If systems are compromised, providers lose confidence in the tools meant to support them, impacting care delivery and potentially leading to burnout. Reputation takes a hit. In a sector built on confidentiality and integrity, a security incident can shatter years of brand building overnight, making it incredibly difficult to attract new patients or partners. Operational paralysis. Beyond data loss, attacks like ransomware can halt critical hospital functions, directly impacting patient care and even leading to adverse outcomes. Our focus can't just be on preventing the how of a breach, but on fortifying against the what if – safeguarding the patient-provider relationship above all else. This means comprehensive strategies that account for third-party risks, legacy system vulnerabilities, and a culture of security that pervades every level of your organisation.

During one of my health informatics classes, a professor posed a question that stuck with me: “Is AI in healthcare building trust or quietly eroding what little we have left?” At first, I was inclined to defend AI—after all, I’ve worked on projects where AI-driven recommendations seemed to make healthcare more efficient. But the more we discussed it in class and in group meetings, the clearer it became that AI might actually be doing more harm than good when it comes to trust. Patients are already cautious about sharing their personal information, and the opaque nature of AI doesn’t help. Unlike a doctor who can explain the rationale behind a diagnosis or treatment, AI often functions as a black box. Patients have no way of knowing how or why certain decisions are made, especially when explanations are either overly technical or non-existent. I remember a project I worked on where an AI tool flagged some patients as high-risk based on patterns in their data. The patients were understandably alarmed, but when they asked why, all we could offer were vague explanations about algorithms and data points. This lack of transparency only deepened their distrust. Moreover, there’s a growing concern that AI might prioritize efficiency and cost savings over genuine patient care. In one of our group discussions, we debated a study showing that some AI-driven diagnostic tools were more focused on throughput—seeing as many patients as possible—than accuracy or individualized care. When patients start to feel like data points rather than people, trust naturally erodes. I’ve seen this firsthand in our pilot of the RxKonet platform, where some patients expressed reluctance to use AI-powered recommendations without clearer explanations and a way to override decisions when needed. Then there’s the issue of data privacy. AI systems thrive on vast amounts of patient data, and every new AI tool seems to demand even more access to sensitive information. Yet, the more data we collect, the less control patients feel they have. It’s not hard to see why patients are hesitant. Scandals involving data misuse or breaches are all too common, and each incident chips away at the fragile trust that remains. To restore trust, AI in healthcare must become more transparent and accountable. Patients need clear explanations for AI-driven decisions, options to review or challenge those decisions, and absolute assurance that their data is safe. Without these changes, AI risks becoming just another barrier between patients and the healthcare system, widening a trust gap that is already too large. As I continue my journey in health informatics and also building the health tech startup, Ngoane this challenge of balancing AI’s potential with the urgent need for trust will remain at the forefront of my mind.

A brilliant medical technology sits unused eighteen months after FDA clearance because hospitals don't trust its outcomes data enough to build value-based contracts around it. This scenario plays out repeatedly across healthcare, where compliance is often treated as a regulatory checkbox rather than the foundation of trust that enables value-based partnerships. The consequences are devastating – innovative solutions that could transform patient care remain stuck in pilot after pilot while companies wonder why their clinical evidence isn't translating to commercial success. The uncomfortable truth is that in value-based care, governance isn't just about avoiding regulatory trouble. It's about building the confidence that allows partners to stake their financial future on your technology's performance. When a health system's shared savings bonus or a payer's medical loss ratio depends on your solution working as promised, they need more than marketing claims – they need systematic evidence and regulatory approvals validating that your processes are trustworthy. Cutting-edge MedTech companies have recognized this shift. They're implementing AI governance frameworks that detect performance drift before it impacts outcomes. They're creating data provenance systems that make patient-generated information trustworthy for clinical decisions. They're building supply chain oversight that ensures security and reliability throughout their technology's lifecycle. Today's newsletter unpacks Pillar 5 of the Value-Based MedTech framework: a comprehensive approach to governance and compliance that transforms these functions from cost centers to strategic enablers. Read on!   ___________________________________________ Sam Basta, MD, MMM is a pioneer of Value-Based Medical Technology and LinkedIn Top Voice. Over the past two decades, he advised many healthcare and medical technology startups on translating clinical and technological innovation into business success. From value-based strategy and product development to go-to-market planning and execution, Sam specializes in creating and communicating compelling value propositions to customers, partners and investors. His weekly NewHealthcare Platforms newsletter is read by thousands of executives and professionals in the US and globally. #healthcareonlinkedin #artificialintelligence #ai #valuebasedcare #healthcare Vivek Natarajan Tom Lawry Subroto Mukherjee Rana el Kaliouby, Ph.D. Rashmi R. Rao Paulius Mui, MD Avi Rosenzweig Mark Miles Deepak Mittal, MBA, MS, FRM Elena Cavallo, ALM, ACC Chris Grasso  

Is FDA Approval the New Caste System in Indian Healthcare? One of the most common questions I hear when a new medical device is introduced—especially if it’s made in India is-  “Is it US FDA approved?”  Not “How does it perform clinically?”  Not “Is it cost-effective?”  Not even “Is it relevant to our patient population?”  Just that one stamp of foreign validation of a different geographical entity who may not even be responsible if something goes wrong. Over time, I’ve come to realize that this isn’t just about regulatory caution. It’s about a deeper perception issue—one that’s quietly shaping our healthcare ecosystem.  We’ve unknowingly created a hierarchy in Indian healthcare, where innovation is judged not by outcomes, but by origin. How excellence made in India must be validated abroad before it is respected at home.  And it's not just a bias; it’s a system.  A subtle, unspoken system—where Indian MedTech is asked to prove itself twice as hard, while imported tech is welcomed without question.  I call it a modern caste system of credibility!! Now, I know that’s a loaded term. But I use it deliberately, because 'caste systems' are about inherited privilege and structural inequality. And in our ecosystem, foreignness has become a shortcut to trust, while Indian-made innovations are put under a microscope—often unfairly. The irony is striking:  - Our doctors are celebrated globally but second-guess their own.  - Our engineers design world-class devices but struggle to place them in Indian hospitals.  - Our healthcare system prides itself on frugality but pays a premium for foreign validation.  And the cost isn’t just economic. It’s emotional. It’s cultural. It’s the erosion of belief—in our own capability.  This is not to say that FDA or CE approvals aren’t valuable—they absolutely are. But they should be a global passport, not a domestic permission slip.  We need to create an environment where Made in India is not a disclaimer, but a declaration.  I say this not as a founder defending his turf, but as someone who genuinely wants to see Indian MedTech rise—not just in labs or factories, but in the minds of our clinicians and institutions.  Because until we shift this mindset, we’ll keep exporting belief and importing trust. And that, more than anything, will keep us from building the future that we are capable of.       

🫡 Good luck to Med Device marketers trying to convince new shoppers to buy their product / share their health data after this 23andMe data fiasco… This is yet another example of the increasing challenge for DTC health marketers — the millions of shoppers flocking to delete their personal health data from 23andMe today…aren’t going to give You their health data tomorrow. Sadly, even if your product is different or your policies are stronger — shoppers often don’t make that distinction. Because when trust erodes in one health brand (especially a large, well known one), it casts a shadow over the entire ecosystem. I remember while at Everlywell, I would hear shoppers say things like “I’m worried you’ll steal my DNA” — we weren’t a DNA testing company 🙃🙃 That’s the problem — shoppers scanning product pages in 7 seconds act with their subconscious, which is trained to mistrust innovative health companies because…all we see are headlines like these ‼️ In this case, now DTC health marketers have to convince new shoppers to trust their data is safe today AND in 8 years when your business is sold to a Private Equity shop, or Pharma company, or whoever else they have even less institutional trust in. 🔐 It’s a powerful reminder that solving for trust is THE unique challenge for the modern DTC health marketer, and it keeps getting harder.