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Digital Therapeutics is in early stages of regulatory maturity: Srinivasa Vivek

Nandita Vijay, Bengaluru
Tuesday, December 14, 2021, 08:00 Hrs  [IST]

Digital Therapeutics is in the early stages of regulatory maturity. Leading regulatory agencies like FDA have come up with specifications including SaMD (software as a medical device) category for better compliance of the digital therapeutics products including safety and efficacy, said Srinivasa Vivek, co-founder, Resolute.

The pandemic has put immense pressure on healthcare systems all over the world. This brought forth the scarcity in terms of availability of clinicians, hospital beds, medical devices and drugs. There is simply not enough to go around during the pandemic too, he added.

It is time for healthcare to move from scarcity to abundance using technology along with the existing ecosystem of resources. One such emerging technology is digital therapeutics, Vivek told Pharmabiz highlighting its importance in the current pandemic times.

Digital Therapeutics is use of clinically validated software to treat, manage and prevent diseases or disorders. Evidence-based interventions are delivered through clinical-grade software with medical practitioners brought to the fore. In fact, Digital Therapeutics scales well for access, personalisation as well as cost. Also, the software increases the attention of patients based on risk criteria which help in better use of clinical resources. Now Resolute is an integrated digital health & wellness service provider of continuous virtual care and digital therapeutics on subscription.

There are multiple emerging classes of digital therapeutics where software alone creates a therapeutic effect. For instance a virtual reality (VR) based software to reduce anxiety. Here the software helps to change a patient's behaviour to create an effect smoking cessation. Further the software is bundled along with a service like coaching diabetes reversal, said Vivek.

“We also see that digital therapeutics also can make a huge impact in chronic condition management including diabetes, metabolic health, blood pressure and cardiovascular conditions. During the pandemic, most of the patients didn't access care due to the non-availability of clinicians, diagnostics as well as fear of exposure to Covid. This has resulted in the condition progressing to more complications which could have been prevented if there is continuous care,” he pointed out.

Digital Therapeutics could make a positive impact by better monitoring and management of the condition, said Vivek adding that it will inevitably become an important driver in the healthcare services transformation.


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