| While the term ‘digital therapeutic’ is still largely unknown, it represents a new category of medical interventions that will significantly influence the way healthcare is delivered and consumed across the world.
Today, the Digital Therapeutics Alliance released a comprehensive report that provides an overview of the industry, defines the term digital therapeutic, and establishes formal product categories. Core principles and best practices related to the design, manufacture, clinical validation, and regulatory oversight of these products are also featured. |
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| What is a Digital Therapeutic? |
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Digital therapeutics (DTx) combine patient-centric technologies with evidence-based medicine to deliver highly personalized care.
DTx products deliver direct therapeutic interventions to patients that are driven by high quality software programs to prevent, manage, or treat a medical disorder or disease. They incorporate advanced technology best practices and are validated by regulatory bodies as required to support product claims regarding risk, efficacy, and intended use.
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The integration of digital therapeutics into patient care is no longer a theoretical conversation. As these products continue to be utilized across the healthcare ecosystem, digital therapeutics will increasingly influence the way healthcare is delivered and consumed across the world.
Digital therapeutics present patients, healthcare providers, and payers with evidence-based technologies that have the ability to elevate medical best practices, address unmet medical needs, expand healthcare access, and improve clinical and health economic outcomes.
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| How Do They Benefit Patients? |
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Digital therapeutics are demonstrating meaningful benefits for stakeholders across the spectrum of healthcare delivery, including:
- Increased access to novel treatment options for conditions that previously have been untreated or undertreated by traditional medications and therapies
- Personalized care delivered to a patient independent of schedule constraints and in the privacy of their own environment
- Reduced stigma associated with the delivery of certain traditional therapies
- Ability to prescribe DTx products to patients as monotherapy or in concert with other therapies
- Intelligent data-driven care management and clinical decision making capabilities
- Improved clinical and health economic outcomes at the patient and population levels for a large range of physical, behavioral, and mental disorders and diseases
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The delivery of personalized treatment interventions to patients places digital therapeutics in a unique position, one full of additional responsibility and promise. Given the diversity of interventions being delivered and the types of disease states addressed, it is important for all products to adhere to industry-adopted core principles and best practices.
Access this report to learn more about the quickly evolving industry, DTx product categories, and industry best practices.
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Over the coming months, DTA will further develop best practices and frameworks that directly support the design, validation, utilization, and regulatory oversight of digital therapeutics across multiple cultures, languages, and national borders.
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The Digital Therapeutics Alliance convenes thought leaders from across the industry – including DTx companies, industry partners, patients, healthcare providers, and payers – to establish foundational best practices and frameworks related to DTx product validation, operations, value, and regulatory oversight.
DTA is a global non-profit trade association with the mission of broadening the understanding, adoption, and integration of clinically-validated digital therapeutics into healthcare through education, advocacy, and research. DTA envisions enabling broad access to high quality, evidence-based digital therapeutics for patients, healthcare providers, and payers in order to improve clinical and health economic outcomes.
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Digital Therapeutics Alliance boosts European presence
DUBLIN, IRELAND – 16 October 2018 – S3 Connected Health News –
- Digital Therapeutics Alliance (DTA) boosts Europe presence to advance the adoption of evidence-based digital therapeutics
- S3 Connected Health, a DTA member, is working alongside fellow EU-based members to lead efforts to integrate digital therapeutics into European healthcare
- DTA engages with patients, providers, payers, and regulators to guide and scale the global digital therapeutics (DTx) industry
The Digital Therapeutics Alliance (DTA) has expanded its European membership by announcing that S3 Connected Health is joining the industry body.
DTA is a global non-profit trade association which aims to broaden the understanding, adoption, and integration of clinically-validated digital therapeutics in healthcare through education, advocacy, and research.
Launched in October 2017, DTA is committed to engaging with patients, providers, payers and regulators to define and develop meaningful resources to guide and scale adoption of digital therapeutics (DTx). It works with industry leaders to aid the introduction of tested and trustworthy digital solutions in healthcare. The Alliance has now grown its global membership to 20 companies, bringing together wide-ranging expertise from firms engaged in implementing digital therapeutics in drug discovery and clinical pathways.
In the US, DTA supports the work of the US Food and Drug Administration (FDA) and related efforts to drive regulatory, clinical, organizational and financial integration of digital therapeutics into mainstream healthcare. The expansion of its European presence will enable the Alliance to progress parallel efforts across the diverse and varied European healthcare ecosystem.
S3 Connected Health specializes in the design and development of digital therapeutics and digital health solutions. Focused on addressing the problem of therapy management and medication non-adherence, which is estimated to account for hundreds of thousands of premature deaths globally each year, costing the pharmaceutical industry around $637bn in lost revenues and compromising positive patient health outcomes.
Having pioneered successful, clinically-validated telehealth solutions in the UK and Italy over the past decade, S3 Connected Health has invested heavily in its Affinial platform, a solution-as-a-service that uses behavioral science techniques and user data to deliver individualized support to help patients to manage their therapy and remain adherent to medications across multiple conditions.
S3 Connected Health will bolster DTA’s presence in Europe and provide a platform for increased understanding of the regulatory, legal and reimbursement pathways on behalf of digital therapeutics firms within institutions including the European Medicines Agency.
Megan Coder, DTA Executive Director, said:
“DTA members are dedicated to advancing novel digital therapeutics aimed at transforming patient clinical outcomes and adding value to patients, caregivers, healthcare providers, and payers. Convening thought leaders from our growing membership and industry partners allows DTA to receive critical input from a wide array of stakeholders in order to establish a strong foundation for this robust and rapidly growing industry.”
Jim O’Donoghue, President, S3 Connected Health, said:
“S3 Connected Health’s expertise in developing and delivering Digital Therapeutics and Digital Health Solutions will help the DTA advance key aspects of the DTx industry.
“Digital therapeutics offer huge potential to dramatically improve patient healthcare outcomes, and we must ensure that this opportunity is realized by engaging with industry stakeholders for effective adoption and integration of DTx in mainstream healthcare, clinical and reimbursement pathways.
“This will enable DTx companies to provide solutions that are able to understand the patient context and provide the right treatment for them — in a way that can be personalized, relevant and context-aware.”
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About S3 Connected Health
S3 Connected Health design and develop digital therapeutics, connected patient care solutions and clinical decision support software. We personalize support and interventions to enable better clinical care, empower patient self-management and improve healthcare outcomes.
For more information on developing patient support programs with S3 Connected Health, visit www.s3connectedhealth.com.
About DTA
The Digital Therapeutics Alliance (DTA) is a global non-profit trade association with the mission of broadening the understanding, adoption, and integration of clinically-validated digital therapeutics into healthcare through education, advocacy, and research. To learn more please visit: www.dtxalliance.org.
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