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Apple and Google's Triple Role as Gatekeepers, Distributors and Developers in the Health App space

  • Writer: Lloyd Price
    Lloyd Price
  • 3 hours ago
  • 5 min read
Apple and Google's Triple Role as Gatekeepers, Distributors and Developers in the Health App space
Apple and Google's Triple Role as Gatekeepers, Distributors and Developers in the Health App space

Apple and Google play all three roles as gatekeepers, distributors, and developers in the health app space, creating a complex dynamic with significant influence over the ecosystem.


Apple and Google as Gatekeepers


Role: They control access to health apps via the Apple App Store and Google Play Store, setting guidelines for inclusion, privacy, and compliance with regulations like the EU Medical Device Regulation (MDR) and GDPR.


Functions


Enforce app quality, safety, and data privacy standards.


Verify compliance for medical device apps (e.g., those with diagnostic or therapeutic functions).


Manage app visibility and rankings, influencing which apps reach users.


Challenges


Conflict of Interest: As developers of their own health apps (e.g., Apple Health, Google Fit), they may favour their products, raising fairness concerns under the EU’s Digital Markets Act (DMA).


Inconsistent Oversight: Apple enforces MDR compliance more rigorously than Google, but both struggle with wellness apps that skirt medical device classification.


Privacy Gaps: Many health apps share sensitive data with third parties, and gatekeeping efforts to curb this are inadequate under GDPR and proposed ePrivacy rules.


Apple and Google as Distributors


Role: They serve as the primary platforms for delivering health and wellness apps to millions of users globally.


Functions


Host and distribute apps, including medical device apps and consumer wellness tools.


Provide developer tools and APIs (e.g., Apple’s HealthKit, Google’s Health Connect) to integrate apps with health data.


Prepare for proposed EU Health Data Space (EHDS) requirements, like voluntary labeling for apps interoperable with electronic health records (EHRs).


Challenges


Regulatory Burden: Distributors must verify compliance with medical device laws, a role explicitly assigned to app stores by EU trade body COCIR.


Scale of Oversight: With nearly 1 million daily healthcare app downloads in 2023, ensuring compliance for thousands of apps is daunting.


Data Sharing: They face scrutiny for allowing apps to share user data with advertisers, often without clear consent.


Apple and Google as Developers


Role: Both create their own health and wellness apps, competing with third-party developers while leveraging their platform control.


Examples


Apple: Apple Health, HealthKit, and features like ECG and blood oxygen monitoring on Apple Watch.


Google: Google Fit, Health Connect, and AI-driven health tools integrated into Android devices.


Functions


Develop consumer-facing apps and tools for medical purposes, some requiring CE marking in the EU.


Integrate apps with proprietary ecosystems (e.g., Apple’s iOS, Google’s Android) for seamless user experiences.


Drive innovation, such as AI personalisation and sensor-based health tracking.


Challenges


Market Dominance: Their dual role as platform owners and developers creates barriers for smaller competitors, who rely on their app stores for distribution.


Regulatory Scrutiny: As developers, they must comply with the same MDR and GDPR rules as third parties, but their gatekeeper status complicates impartial enforcement.


Trust Issues: Users and regulators question whether they prioritise profit over privacy, especially with sensitive health data.


Implications of Their Triple Role


Market Control: Their “duopoly” over app distribution gives them unmatched influence, potentially stifling competition and innovation. The DMA aims to curb this by promoting fair access.


Regulatory Pressure: The EHDS (expected ~2025) and MDR increase their responsibilities as gatekeepers and distributors, while their developer role invites scrutiny for conflicts of interest.


Privacy and Trust: Weak enforcement of data privacy policies undermines user confidence, especially as health apps handle sensitive information.


Innovation vs. Oversight: Their developer role drives health tech advancements (e.g., AI, wearables), but lax gatekeeping allows non-compliant or low-quality apps to proliferate.


Apple and Google’s dominance as gatekeepers, distributors, and developers creates an uneven playing field. Their ability to prioritize their own apps while controlling access for others raises ethical and competitive concerns. Regulatory frameworks like the DMA and EHDS aim to address this, but enforcement lags behind their market power. Smaller developers struggle to compete, and users face risks from poorly regulated apps. Stronger, independent oversight and transparent privacy practices are needed to balance innovation with accountability.

Key Trends and Future Directions


  • EU Regulatory Evolution: The EHDS will introduce voluntary labelling for wellness apps, aligning them closer to medical device standards, increasing the workload for gatekeepers and distributors.


  • Global Policy Convergence: Countries like Germany, Belgium, and the UK are developing centralized frameworks for app approval, while the US explores models like the Software Precertification Pilot Program. Cross-border collaboration is needed for scalability.


  • Commercial Intermediaries: Organisations like ORCHA and Xealth are emerging as alternative gatekeepers/distributors, helping integrate apps into healthcare systems.


  • Consumer Demand: Nearly 1 million healthcare app downloads per day in 2023 reflect surging demand, particularly for blood pressure and self-therapy apps, pushing developers to innovate.


  • AI Integration: Developers are increasingly using AI (e.g., Google’s AI tools for health) to personalize solutions, but this raises new regulatory and ethical questions.


Proposed Solutions


  • Improved Oversight: Apple and Google must strengthen compliance checks, potentially via third-party auditors, to resolve conflicts of interest and meet EU MDR standards.


  • Transparent Frameworks: Centralised directories of approved apps, as seen in Germany and Belgium, could reduce confusion for users and developers.


  • User Feedback Mechanisms: Gatekeepers should maintain permanent app reviews to highlight safety issues, especially for mental health apps, and protect user privacy.


  • Public Advocacy: Consumers and governments should push for stricter privacy policies and transparent app store practices to protect sensitive health data.


The dominance of Apple and Google as gatekeepers and distributors creates a “Wild West” environment where regulatory enforcement lags behind innovation. Their dual role as developers undermines trust, as they may prioritize their own apps or overlook non-compliant ones to maintain market control. While EU regulations aim to tame this, their success depends on consistent enforcement and addressing the duopoly’s inherent conflicts. Developers, especially smaller startups, face an uphill battle, but emerging frameworks and intermediaries offer hope for a more equitable ecosystem. Privacy remains a critical blind spot—without robust gatekeeper action, sensitive health data risks exploitation by third parties.

Nelson Advisors > Healthcare Technology M&A

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