Digital Therapeutics Platforms And Treatment Gatekeeping Power

1. Introduction

Digital Therapeutics (DTx) platforms are software-based therapeutic systems designed to prevent, manage, or treat medical conditions. They may deliver cognitive behavioural therapy, addiction treatment, diabetes management, insomnia therapy, neurological rehabilitation, or other clinically validated interventions through mobile applications, connected devices, cloud platforms, and algorithmic decision systems.

The competition-law concern arises when a DTx platform becomes a gatekeeper for access to treatment. A platform may control access to patients, clinicians, pharmacies, insurers, employers, app stores, medical data, reimbursement channels, or complementary therapeutic products. Once such control becomes sufficiently significant, the platform may be able to determine which therapies reach patients, which providers receive visibility, what prices are charged, and which competitors can interoperate with the system.

The central competition question is therefore:

When does legitimate clinical or technological control over a digital therapeutic ecosystem become exclusionary gatekeeping power?

This issue is particularly important because DTx markets combine healthcare, digital platforms, data, intellectual property, professional regulation, and network effects.

2. Meaning of Treatment Gatekeeping Power

Treatment gatekeeping power refers to the ability of a digital platform to substantially influence or control a patient's access to therapeutic services or products.

A DTx platform can acquire such power through control over:

1. Patient access
2. Clinician interfaces
3. Prescription or referral systems
4. Insurance reimbursement
5. Pharmacy integration
6. App distribution
7. Clinical data
8. Interoperability standards
9. Algorithmic treatment recommendations
10. Device compatibility
11. Authentication and identity systems
12. Digital therapeutic marketplaces

Gatekeeping is not automatically unlawful. A platform may legitimately impose clinical safety requirements, privacy standards, cybersecurity requirements, or evidence thresholds.

The competition problem emerges where those requirements are used strategically to exclude competing treatments or providers.

3. Why DTx Platforms Are Particularly Vulnerable to Gatekeeping

A. Strong network effects

A successful DTx platform may attract:

Patients → clinicians → developers → insurers → pharmacies → more patients

This creates reinforcing network effects.

A competing platform may therefore struggle even if its therapeutic technology is superior because it lacks access to the established ecosystem.

B. Data advantages

DTx platforms can accumulate:

• treatment histories;
• adherence data;
• physiological data;
• patient preferences;
• behavioural information;
• clinical outcomes;
• prescription information; and
• engagement data.

This information can improve algorithms and create a data feedback loop.

More patients produce more data → more data improves treatment algorithms → better algorithms attract more patients → more patients produce more data.

A dominant platform can therefore develop an advantage that is difficult for new entrants to replicate.

4. Treatment Gatekeeping as an Abuse-of-Dominance Problem

Competition law generally becomes relevant where the platform possesses substantial market power or dominance.

Potential theories of abuse include:

1. Refusal to deal

A dominant DTx platform may refuse competitors access to:

• patient interfaces;
• essential data;
• APIs;
• interoperability infrastructure;
• clinician networks; or
• reimbursement systems.

2. Self-preferencing

The platform could give its own therapeutic products preferential placement.

For example:

A platform operating a digital-therapy marketplace ranks its own insomnia treatment above rival products despite equivalent clinical evidence.

This can reduce competitors' visibility and patient acquisition.

3. Exclusive dealing

The platform may require clinicians, insurers, employers, or healthcare providers to use only its DTx products.

This may foreclose competing therapeutic platforms.

4. Tying and bundling

A platform could condition access to one essential service on purchasing another.

For example:

Access to a dominant diabetes-management platform may be conditioned upon adoption of the platform's proprietary glucose-monitoring ecosystem.

5. Discriminatory interoperability

The platform could provide its own DTx products with superior technical access while limiting competing products.

6. Excessive or discriminatory access charges

A dominant platform could impose disproportionately high fees on competing therapeutic providers.

7. Algorithmic exclusion

Treatment recommendations or ranking algorithms may systematically favour affiliated products.

The problem is particularly difficult because exclusion can occur without an explicit contractual restriction.

5. Market Definition

Several relevant markets may coexist.

A. DTx product market

Possible markets include:

• digital mental-health therapy;
• digital diabetes management;
• digital addiction treatment;
• digital sleep therapy;
• neurological rehabilitation software.

B. Platform market

The relevant market could instead concern the intermediary platform connecting:

patients + clinicians + therapeutic developers + payers.

C. Data market

Where patient data is commercially valuable, competition authorities may consider markets involving access to:

• health datasets;
• treatment data;
• behavioural datasets; and
• clinical outcome information.

D. Multi-sided market

DTx platforms frequently operate as multi-sided markets.

For example:

Patients ↔ DTx developers ↔ Clinicians ↔ Insurers

Conduct affecting one side can indirectly affect competition on another.

6. Treatment Gatekeeping and Essential-Facility Reasoning

A DTx platform may argue:

"Competitors have no right to access our platform."

Ordinarily, competition law does not require firms to share everything they own.

However, exceptional circumstances may arise where access to an infrastructure or input is indispensable for effective competition.

Relevant considerations include:

1. indispensability;
2. elimination of effective competition;
3. absence of viable alternatives;
4. technical feasibility of access;
5. capacity constraints;
6. objective justification; and
7. proportionality of access conditions.

The doctrine becomes particularly relevant when a platform controls an ecosystem through which patients cannot realistically access competing treatments.

7. Six Important Case Laws

1. Bronner v Mediaprint

Oscar Bronner GmbH & Co KG v Mediaprint Zeitungs und Zeitschriftenverlag GmbH & Co KG

The Court of Justice established important limitations on refusal-to-deal claims under Article 102 TFEU.

The case is significant because access to a dominant firm's infrastructure cannot automatically be demanded merely because that infrastructure is advantageous.

DTx relevance

A competing DTx provider would need to demonstrate more than inconvenience.

It may have to show that the dominant platform's infrastructure is effectively indispensable and that exclusion would substantially eliminate competition.

Thus, Bronner provides an important safeguard against turning every platform dependency into a compulsory-access obligation.

2. IMS Health

IMS Health GmbH & Co OHG v NDC Health GmbH & Co KG

The case concerned access to a copyrighted system used for pharmaceutical sales data.

The Court developed important principles concerning compulsory licensing and intellectual property.

DTx relevance

DTx platforms frequently combine:

• software;
• proprietary databases;
• algorithms;
• clinical interfaces; and
• intellectual property.

A platform could therefore attempt to prevent competitors from using a proprietary architecture necessary to reach patients.

IMS Health demonstrates the tension between IP rights and competition policy.

The mere existence of intellectual property does not automatically establish an antitrust violation, but exceptional circumstances can justify intervention.

3. Slovak Telekom v Commission

Slovak Telekom a.s. v European Commission

The case concerned exclusionary conduct involving access to telecommunications infrastructure.

The Court considered the relationship between refusal-to-deal principles and margin-squeeze conduct.

DTx relevance

A DTx platform may simultaneously operate:

• the infrastructure;
• the patient interface; and
• competing therapeutic products.

It could therefore disadvantage rivals through access conditions while maintaining its own downstream therapeutic service.

The case illustrates how vertical integration can convert infrastructure control into competitive leverage.

4. Google Shopping

Google Search (Shopping)

The European Commission's Google Shopping case concerned the preferential positioning of Google's own comparison-shopping service in general search results.

The case is highly relevant to DTx because ranking can itself constitute an important competitive gateway.

DTx application

Imagine a dominant DTx marketplace displaying:

Platform-owned therapy — first position
Independent therapy — page 5

Even without formally preventing access, the platform could materially influence patient choice.

The competition concern is therefore not limited to outright exclusion.

Visibility itself can become a gatekeeping resource.

5. Google Android

Google Android

The case concerned Google's conduct involving Android devices, including restrictions associated with Google Search and the Play Store ecosystem.

The case illustrates how control over an ecosystem can be used to reinforce the position of an associated service.

DTx relevance

A DTx ecosystem may involve:

Operating system → app store → authentication → payment → therapeutic application

If the platform controls multiple layers, it may be capable of disadvantaging competing therapeutic applications.

Potential concerns include:

• pre-installation;
• default placement;
• app-store restrictions;
• payment requirements;
• interoperability limitations; and
• restrictions on alternative distribution.

6. Apple – App Store / music-streaming litigation

The competition-law disputes concerning Apple's App Store practices provide important insight into platform gatekeeping and access conditions.

Apple's control over app distribution gives it the ability to establish rules affecting downstream digital businesses.

DTx relevance

If digital therapeutics are distributed primarily through an app-store ecosystem, the app store can become a critical gateway between:

DTx developer → patient

Potential competition issues include:

• commission structures;
• payment restrictions;
• anti-steering provisions;
• discriminatory review;
• ranking;
• technical restrictions; and
• differential treatment of affiliated services.

This makes app-store governance particularly important to digital healthcare competition.

8. Additional Relevant Case Laws

7. Microsoft v Commission

The Microsoft case is highly relevant to interoperability.

Microsoft's conduct concerning interoperability information demonstrated how control over technological interfaces can affect competition in downstream markets.

DTx significance

A dominant DTx platform might control APIs connecting:

• wearable devices;
• electronic health records;
• clinical systems;
• pharmacies;
• insurers; and
• competing therapeutic applications.

Restricting interoperability can increase switching costs and preserve dominance.

8. United Brands v Commission

United Brands Company v Commission

The case remains foundational for understanding dominance and exclusionary behaviour under Article 102 TFEU.

DTx significance

A DTx platform possessing substantial market power cannot necessarily use its dominance to impose conditions that unfairly restrict competitive opportunities.

The case is useful when assessing whether platform conduct goes beyond legitimate commercial competition.

9. Magill

RTE and ITP v Commission (Magill)

Magill concerned compulsory access to copyrighted television-programme information.

Its significance lies in the exceptional circumstances under which refusal to license intellectual property may become abusive.

DTx application

Where clinical data, treatment information, or interoperability resources are protected by IP, Magill helps structure the analysis of whether withholding access prevents the emergence of a new product or service.

10. MEO v Autoridade da Concorrência

MEO – Serviços de Comunicações e Multimédia SA v Autoridade da Concorrência

The case examined discriminatory pricing and the requirement to establish competitive disadvantage in the context of Article 102(c).

DTx relevance

A DTx platform might charge competing therapeutic providers different:

• commissions;
• data-access fees;
• API charges; or
• transaction fees.

Differential treatment is not necessarily unlawful, but it becomes problematic if it places competitors at a competitive disadvantage.

9. Self-Preferencing in DTx

Self-preferencing may become one of the most significant future competition issues.

Suppose a platform operates:

1. a DTx marketplace;
2. a patient-rating system;
3. a clinical recommendation algorithm; and
4. its own therapeutic products.

It could theoretically manipulate the ecosystem to favour its own products.

The platform would simultaneously be:

market operator + ranking authority + treatment provider.

This creates a structural conflict of interest.

10. Algorithmic Treatment Gatekeeping

Algorithmic recommendations present a more sophisticated problem.

A platform might not explicitly tell patients to select its own therapy.

Instead, an algorithm could influence:

• which treatment appears first;
• which clinician is recommended;
• which therapy receives an automated approval;
• which products are covered by a digital formulary;
• which therapy receives reimbursement; and
• which patients are referred to which provider.

The competitive effect could therefore arise through algorithmic architecture rather than contractual exclusion.

11. Data as a Gatekeeping Instrument

Data can operate as a competitive bottleneck.

A dominant DTx platform may possess extensive longitudinal data that competitors cannot easily reproduce.

For example:

Patient → treatment → response → behavioural data → algorithm → improved treatment

This creates a feedback loop.

A new competitor may face a substantial disadvantage because it lacks sufficient historical data to train equivalent algorithms.

Competition authorities may therefore consider:

• data portability;
• interoperability;
• API access;
• data silos;
• data exclusivity; and
• switching mechanisms.

12. Switching Costs and Patient Lock-In

Patient switching can be difficult because a therapeutic platform may contain:

• treatment histories;
• progress records;
• personalised recommendations;
• clinician communications;
• wearable-device integrations;
• behavioural profiles; and
• insurance information.

Consequently, even where another DTx product is cheaper or clinically attractive, patients may remain locked into the incumbent.

This creates digital treatment inertia.

13. Vertical Integration

A particularly serious risk occurs when a platform simultaneously controls:

Platform + data + distribution + therapy

For example:

A dominant platform provides the DTx operating infrastructure while also selling competing therapeutic applications.

It may then have incentives to restrict rivals at several levels simultaneously.

Potential theories include:

• tying;
• bundling;
• discriminatory access;
• self-preferencing;
• margin squeeze;
• refusal to deal; and
• exclusionary interoperability restrictions.

14. Legitimate Gatekeeping vs Anticompetitive Gatekeeping

Not every restriction should be condemned.

The critical question is whether the restriction is objectively necessary and proportionate.

15. Consumer Welfare Issues

Traditional competition analysis may focus on price.

That is inadequate for DTx markets because many products are:

• free;
• subscription-based;
• reimbursed by insurers; or
• provided through employers.

Competitive harm may instead appear through:

Quality

Patients may receive inferior therapeutic options.

Privacy

Reduced competition may allow greater exploitation of health data.

Innovation

Entrants may be discouraged from developing alternative therapies.

Choice

Patients may encounter fewer therapeutic alternatives.

Clinical outcomes

Exclusion of competing technologies may reduce therapeutic effectiveness.

Thus, DTx competition law should consider quality, innovation, privacy, choice, and clinical outcomes, not merely price.

16. Regulatory Interaction

DTx platforms operate within several regulatory environments.

Competition authorities must potentially coordinate with:

• healthcare regulators;
• medical-device regulators;
• data-protection authorities;
• pharmaceutical regulators;
• insurance regulators; and
• consumer-protection authorities.

A platform should not be permitted to claim:

"This is a healthcare regulation issue, not a competition issue"

where regulatory requirements are being strategically manipulated to foreclose competitors.

Conversely, competition authorities must avoid overriding genuine patient-safety requirements.

17. Remedies

Possible competition-law remedies include:

A. Non-discriminatory access

Require platforms to provide equivalent access to competing DTx providers.

B. Interoperability

Require APIs or technical interfaces where appropriate.

C. Data portability

Allow patients to transfer relevant data between platforms.

D. Ranking transparency

Require explanation of material ranking criteria where appropriate.

E. Anti-self-preferencing rules

Prevent affiliated products from receiving unjustified preferential treatment.

F. Separation of functions

In extreme cases, structural separation between:

platform operator and therapeutic provider

could be considered.

G. Non-exclusivity

Restrict contracts preventing clinicians, insurers, or healthcare providers from using competing DTx systems.

18. Key Legal Test

A useful competition-law framework is:

Market Definition
↓
Platform Market Power
↓
Control Over Treatment Access
↓
Identification of Gatekeeping Mechanism
↓
Exclusionary Effect
↓
Competitive Harm
↓
Objective Justification
↓
Proportionality
↓
Remedy

19. Key Case-Law Principles at a Glance

20. Conclusion

Digital therapeutics platforms can evolve from ordinary healthcare software into critical treatment gateways. Their control over patients, clinicians, data, algorithms, distribution channels, reimbursement systems and interoperability can give them considerable competitive leverage.

The principal competition-law danger is not simply that a dominant DTx platform charges high prices. It is that the platform can control the competitive conditions under which alternative treatments reach patients.

The most important future issues are likely to involve:

• self-preferencing of platform-owned therapies;
• discriminatory access to patient interfaces;
• proprietary clinical data;
• algorithmic treatment recommendations;
• app-store restrictions;
• interoperability;
• exclusive clinician arrangements;
• insurance-platform integration;
• switching costs; and
• leveraging dominance from digital infrastructure into therapeutic markets.

The case law from Bronner, IMS Health, Microsoft, Slovak Telekom, Google Shopping, Google Android, Magill, United Brands and MEO provides the principal conceptual foundations for analysing these problems.