Green Room Technologies Ideas

Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

A digital health technology (DHT) is a system that uses computing platforms, connectivity, software, and/or sensors, for healthcare and related uses. This guidance provides recommendations for sponsors, investigators, and other interested parties on the use of DHTs for remote data acquisition from participants in clinical investigations evaluating medical products. There is a large spectrum of DHTs available for potential use in a clinical investigation, some of which meet the definition of a device under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and some of which do not. DHTs may take the form of hardware and/or software. In many instances, DHT software may run on general-purpose computing platforms (e.g., mobile, phone, tablet, or smart watch). A clinical investigation can use multiple DHTs to collect a range of information that may include clinical, physiological, psychological, behavioral, or functional data. This guidance outlines recommendations intended to facilitate the use of DHTs in a clinical investigation as appropriate for the evaluation of medical products. These recommendations address some of the information that should be contained in an investigational new drug application (IND) or an investigational device exemption (IDE) application for a clinical investigation in which the sponsor plans to use one or more DHTs or in a marketing application that includes such a clinical investigation.

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Doctor taking an elderly female's blood pressure
Client News

Tech helps cut Stockport hospital admissions by almost 40%, saving £2.5m

Smart phone and Bluetooth technology, linked to an innovative digital remote care system, has cut hospital admissions in the Stockport area by almost 40%, saved the NHS more than £2m and empowered patients at home.

A digital solution, developed by Norwegian medical software company Dignio and adopted by Stockport-based Mastercall Healthcare – a social enterprise ‘not for profit’ provider of NHS healthcare – has allowed many COVID-19 patients to remain safely at home, instead of being admitted to hospital.

Dignio opened a Manchester office earlier this year, close to Piccadilly rail station.

The same tech system has also been used in 20 care homes in the area, where it has again been helping to take the pressure off stretched NHS services.

Patients with smartphones and care home staff using tablets, download an app and can be instantly connected to devices including a thermometer, pulse oximeter and blood pressure monitor.

It means that those with mild coronavirus symptoms and residents in care homes, with a variety of long term health conditions, can be checked regularly.

Read More »
Doctor taking an elderly female's blood pressure
Client News

Tech helps cut Stockport hospital admissions by almost 40%, saving £2.5m

Smart phone and Bluetooth technology, linked to an innovative digital remote care system, has cut hospital admissions in the Stockport area by almost 40%, saved the NHS more than £2m and empowered patients at home.

A digital solution, developed by Norwegian medical software company Dignio and adopted by Stockport-based Mastercall Healthcare – a social enterprise ‘not for profit’ provider of NHS healthcare – has allowed many COVID-19 patients to remain safely at home, instead of being admitted to hospital.

Dignio opened a Manchester office earlier this year, close to Piccadilly rail station.

The same tech system has also been used in 20 care homes in the area, where it has again been helping to take the pressure off stretched NHS services.

Patients with smartphones and care home staff using tablets, download an app and can be instantly connected to devices including a thermometer, pulse oximeter and blood pressure monitor.

It means that those with mild coronavirus symptoms and residents in care homes, with a variety of long term health conditions, can be checked regularly.

Read More »
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