Preparing patientMpower for the UK market
Digital health interventions hold the promise of positively impacting on patients’ health outcomes while also offering the potential to prevent disease and lower the cost of healthcare. But to achieve mainstream success, suppliers need the ability to scale at pace, and offer the NHS a variety of off-the-shelf solutions that can be readily adopted when the need arises.
It’s no secret that breaking into the NHS comes with its challenges. The complex procurement frameworks and governance requirements can be stifling, particularly for newcomers. But as the largest healthcare delivery organisation in the world, overcoming these hurdles can also be extremely rewarding on many levels. That’s where 8foldGovernance can help.
The key objective for any new health technology supplier to the NHS should be to improve clinical safety and patient outcomes.
Streamlining the journey to the NHS
One provider that held bold ambitions to enter the NHS is patientMpower (pMp). As a digital healthcare company based in Ireland, pMp provides virtual care solutions for people living with chronic illness including lung, kidney and heart conditions.
Lyndon Johnson, CEO and Clinical Safety Lead of 8fold Governance, met patientMpower CEO, Eamonn Costello, at a conference and immediately appreciated the pMp offering and its potential. At that point, patientMpower’s efforts had been focused on servicing Ireland where it is now seen as a key player in the digital health space. However, the company had no resource dedicated to tackling the UK market, or prior experience of the NHS.
What is a clinical
A Clinical Safety Officer or ‘CSO’ is a mandated function for health IT system suppliers that requires the acting individual to be a registered Healthcare Professional (HCP). For Digital health technology providers, enlisting the CSO service from 8foldGovernance removes the need to hire an expensive internal resource.
8fold Governance has supported patientMpower with the following challenges:
- navigating the journey to procurement
- brokering commercial partnerships
- offering assurance (with evidence) to potential customers that pMp’s solutions comply with the stringent NHS requirements
- providing a clinical safety officer and completing the DCB0129 process
- producing Data Protection Impact Assessments
- brokering an outsourced business development function.
The policy context
The NHS Digital Technology Assessment Criteria (DTAC) was introduced in February 2021 as the new national baseline criteria for all digital health technology deployed into the NHS and social care. Under DTAC, health IT system suppliers to the NHS are assessed for their clinical safety, data protection, technical security, interoperability, usability and accessibility standards.
Lyndon says: “The key objective for any new health technology supplier to the NHS should be to improve clinical safety and patient outcomes.” He believes that clinical risk management is therefore a practice that suppliers should firmly embed into their development and implementation processes.
Did you know?
According to a recent report on digital health trends by the IQVIA Institute for Human Data Science, there are now more than 350,000 digital health apps available to consumers. Out of these, more than 90,000 were introduced during 2020. The majority of apps – some 47%, focus on managing specific diseases or health conditions, with mental health, diabetes and cardiovascular disease-related apps making up almost half of the condition-specific apps.
Clinical risk management is a core component of the DTAC. It requires due consideration into what could go wrong with clear documentation on what will be done to mitigate any risks. This is measured under the DCB0129 information standard.
To support pMp with their DTAC obligations under the DCB 0129 standard, 8foldGovernance carried out a Clinical Safety Management Scoping Review and produced a report with all the documentation pMp needed to comply with the information standard. As a result, pMp achieved compliance with the DCB 0129 standard within one month. This includes a requirement for a named Clinical Safety Officer (CSO), which is a duty that 8foldGovernance is instructed to perform on behalf of pMp.
In addition to the DTAC compliance support, pMp also benefited from 8fold’s integrated services for information governance and data protection support, as well as business development support via our strategic partner, Quiddity Health which now represents pMp within the NHS.
CEO, patientMpower, Eamonn Costello, said: “8foldGovernance has been a great partner of patientMpower, assisting us primarily in information governance and clinical safety analysis and planning. I would highly recommend 8foldGovernance to any digital healthcare company looking to sell into the NHS.”
Since 8foldGovernance was instructed, pMp has been able to secure an NHS contract and meet all governance requirements in the UK. All the information governance and CSO compliance elements were promptly resolved and as a result, 8foldGovernance also secured a technical integration with Europe’s largest supplier of personal health records to the NHS, which is readily available to over 5 million patients in the UK alone.
patientMpower is a digital healthcare company based in the Republic of Ireland. It Provides virtual care solutions for people living with chronic illness including lung,kidney and heart conditions. The technology solution is a patient-facing app that connects wearable devices via bluetooth to empower patients to manage their health from the comfort of their own home, while at the same time seamlessly share vital data with their healthcare practitioners.
Remote monitoring with patientMpower can free up hospital resources for patients that most need face-to-face intervention by decreasing the need for outpatient clinics, avoiding in-patient admissions and facilitating early discharge.
Healthcare staff and patients are alerted to indicators of more severe disease (e.g. oxygen saturation <94%) for rapid triage to GP or hospital. Remote data collection enables healthcare professionals make informed decisions for better patient outcomes.
Patient and staff exposure to COVID-19 or other hospital acquired infections is reduced by limiting the need for face-to-face assessment.