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Trinity: Deep Dive
The AI Context Layer: The Missing Link in AI-Ready Data
Most commercial life sciences organizations have invested heavily in data. They have lakehouses, harmonized data feeds, and dashboard environments like Power BI, Tableau, and Snowflake that teams rely on daily. These tools already carry semantic models: metric definitions, schema relationships, and governed sources. The analytics infrastructure is real. Yet when they try to build AI on top of it, they hit the same wall: the AI doesn’t understand their business.
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How Effective is ANVISA’s Rare Diseases Expedited Approval Pathway [RDC 205]?
An analysis was conducted of all the orphan therapies registered by the FDA and ANVISA before and after 2018 to effectively evaluate approval times once the RDC 205 pathway was implemented. The main takeaways from the analysis can be found below [...]
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EU Adopts Regulation on Pan-European Health Technology Assessment
Pan-European HTA will enter into force in January 2022 and finally become active in 2025. This comes almost four years after the European Commission’s original proposal, and at a time where urgency for European HTA processes is growing [...]
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Key Changes to Health Technology Assessments (HTAs) in the UK
The National Institute for Health and Care Excellence (NICE) will mark the start of 2022 by implementing changes to health technology assessments (HTAs), demonstrating adaptability of regulatory bodies as medical technologies continue to evolve. The final HTA changes aim to provide...
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Bypassing NICE: Manufacturers are Looking Towards NHS England to Support Early Access
There has been a trend in manufacturers opting to bypass the NICE appraisal process and have struck deals with NHS England directly to support market access for their novel therapies.
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Global Evidence Requirements to Launch a Digital Health Technology
In this article, Trinity analyzed existing guidelines and evaluation frameworks for digital health technologies, including mobile health (mHealth) applications, to identify key evidence requirements and areas that should be considered in the clinical assessment of digital health services.
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Are Current Reimbursement Options for Opioid Use Disorder DTx Causing a Barrier to Widespread Adoption in the USA?
In 2020, Trinity assessed three applications developed to treat Opioid Use Disorders (OUD) (e.g., reSET-O, Connections, DynamiCare) through the lens of ICER conducting a cost-effectiveness evaluation. Only a year later, several more health tech startups have adopted a preventative outlook and seek...
