Category: Opinion piece

Antimicrobial Pharmacist and part of the HIHI team, Dr Diana Hogan-Murphy, explores some Covid-19 investigation approaches and tech supports.

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Throughout history there have been a number of pandemics, defined as a worldwide spread of a new disease.

The Black Death, also known as the Plague, has been recorded as the most fatal pandemic with an estimated 75–200 million fatalities in the 14th century which included half of the population of Europe.

More recent notable pandemics include the 1918 H1N1 influenza pandemic (Spanish flu) with an estimated 50m deaths, the 2009 H1N1 pandemic (swine flu), and the current HIV pandemic/epidemic with approximately 32m deaths.

The first case of coronavirus disease 2019 (Covid-19) was officially reported to the World Health Organization (WHO) in December 2019 in Wuhan, the capital of China’s Hubei province, and declared a pandemic in March 2020.

The virus has now spread globally to over three million confirmed cases and 220,000 deaths.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the novel virus that causes Covid-19.

It is part of a large family of coronaviruses that circulate among animals and can transfer to humans and cause infections such as the common cold (among other possible causes, predominantly rhinoviruses), severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome (MERS).

Rarely animal coronaviruses infect people and then spread between people which has been seen with SARS which originated from civet cats, MERS which originated from drometary camels, and now Covid-19.

It appears likely that bats, which have close genomic sequence similarities to SARS-Cov-2, are the primary source of transmission to humans.

Whether the virus is transferred directly from bats or through an intermediate host is unknown.

It spreads primarily through droplets generated when an infected person coughs or sneezes or through droplets of saliva or nasal discharge.

The main mechanism of transfer is directly from person to person in close proximity.

Another mechanism is touching infected surfaces and then transferring the virus to one’s eyes, nose, or mouth.

SARS-Cov-2, one-nine hundredth of a width of a strand of hair, can survive on different surfaces from several hours (copper, cardboard) up to a few days (plastic, stainless steel). However, the amount of viable virus declines over time and may not be present in sufficient numbers to cause infection.

The virus has been cultured from stool samples, but faecal-oral transmission does not appear to be a significant factor in the spread of infection.

Analysis of Irish epidemiological data to date indicate one infected person will infect less than one other individual, a continued decline from revised estimates of a reproduction number of between four and five.

This is predominantly due to the collective effort of citizens to abide by recommendations made by the National Public Health Emergency Team regarding good hand hygiene practice, respiratory etiquette, social distancing, and self-isolation as required.

Literature on use of face masks as a preventative measure of community transmission has produced equivocal results with no definitive answers.

Health Service Executive (HSE) guidelines do not recommend universal use of masks primarily as they may create a false sense of security with neglect of other essential measures and increase frequency of face touching from mask adjustments.

Wearing face masks in public places to reduce disease transmission from potentially asymptomatic carriers is recommended by government agencies in several countries including the US, Canada, China, Germany (mandatory), Italy, Scotland, Czech Republic (mandatory), Austria, Poland (mandatory), Israel, Singapore, and South Korea.

With regard to healthcare providers, the HSE recommend that surgical masks should be worn when caring for patients within two metres regardless of the Covid-19 status of the patient, and that surgical masks should be worn by all healthcare providers for all encounters of 15 minutes or more with other healthcare providers in the workplace where a distance of two metres cannot be maintained.

Clinical manifestations
Estimates of the incubation period range from 2-14 days, most commonly five days, and can roughly be divided into three stages: an asymptomatic incubation period with or without detectable virus; a non-severe symptomatic period with the presence of virus; and a severe respiratory symptomatic stage with high viral load.

The role of asymptomatic SARS-CoV-2 infected individuals in disseminating the infection remains to be defined but the risk of transmission is thought to be greatest when patients are pre-symptomatic and symptomatic.

Viral RNA levels from upper respiratory specimens appear to be higher soon after symptom onset compared with later in the illness.

However, detection of viral RNA does not necessarily indicate the presence of infectious virus. There are no specific clinical features that can yet reliably distinguish Covid-19 from other viral respiratory infections. Common symptoms for the general population include a fever, dry cough, shortness of breath, fatigue, and myalgia.

Typical symptoms may be absent in older adults despite respiratory disease: atypical presentation includes confusion, generalised weakness and functional decline, loss of appetite, diarrhoea, nausea, vomiting, abdominal pain, headache, chest pain, and unexplained changes in baseline condition.

Pneumonia appears to be the most frequent serious manifestation of infection, characterised primarily by fever, cough, dyspnoea, and bilateral infiltrates on chest imaging.

Severe illness and death can occur in otherwise healthy individuals of any age, but rises significantly in persons over 65 years and in those with defined risk factors including hypertension, diabetes, cardiovascular disease, chronic respiratory disease, compromised immune status, cancer, and obesity.

Approximately 80 per cent of cases of Covid-19 are mild to moderate, 14 per cent have severe disease, and 6 per cent require critical care. Recovery time appears to be two weeks for mild infections and three to six weeks for severe disease.

The WHO has called on countries to ‘test, test, test’. The number of confirmed cases is what informs societies about the development of the pandemic, how to respond appropriately to the threat, and learn if countermeasures are successful.

In Ireland, the testing criteria comprise priority groups presenting with one of three symptoms: a fever, acute cough, or acute shortness of breath.

Priority cohorts include close contact with a confirmed or probable case in the last 14 days prior to symptom onset; front-line healthcare providers and their households; at risk groups and their households; staff and residents of nursing homes (current recommendation is to test all residents and staff in a facility with one or more confirmed cases); those in Direct Provision and in Roma and Travelling community settings; the homeless; prison staff and inmates; and pregnant women.

The present goal is to process 100,000 tests weekly for the next six months within the 25 laboratories available inclusive of 20 hospital laboratories, a sizable laboratory in Germany, and the National Virus Reference Laboratory.

Whilst polymerase chain reaction (PCR) testing of respiratory tract samples is the recommended method for identification and laboratory confirmation of Covid-19 cases, multiple diagnostic test manufacturers have developed rapid easy-to-use devices to facilitate testing outside of laboratory settings based on detection of proteins from the virus.

The WHO and Health Information and Quality Authority (HIQA) recommend use of these tests only in research settings and not for clinical decision-making until further evidence is available on their sensitivity and specificity.

In addition, research groups worldwide are analysing wastewater for Covid-19 as a way to estimate the total number of infections in a community, given many individuals will not be tested.

To reliably quantify the scale of infection in a population from wastewater samples, the varying amounts of viral RNA excreted in faeces will need to be captured and then extrapolated from the number of infected people from a representative sample.

Sewage surveillance has previously been used to detect outbreaks of norovirus, multidrug resistant organisms, poliovirus, and measles.

Investigational approaches
Management consists of supportive care, although investigational approaches are being evaluated. At this time, while there are a number of medicines being investigated for treatment of Covid-19, none have yet to demonstrate safety and efficiency.

These include remdesivir, lopinavir/ritonavir, and hydroxychloroquine.

Several randomised control trials are underway to evaluate the efficacy of remdesivir for Covid-19. Remdesivir is an investigational intravenous broad-spectrum anti-viral drug which was developed as a potential treatment for the West African Ebola virus epidemic in 2015.

It is a novel nucleotide analogue that has activity against SARS-CoV-2 and related betacoronaviruses (including SARS and MERS) both in vitro and in animal studies. Reported side effects include nausea, vomiting, and transaminase elevations.

Remdesivir is not commercially available; it is available as part of several ongoing clinical trials or from the manufacturer Gilead for treatment of Covid-19.

Individual compassionate use requests are limited to pregnant women or patients <18 years of age with confirmed Covid-19 and severe disease. The drug can be obtained through an expanded access programme at two sites in Ireland for other populations.

If access to remdesivir is possible, either through a clinical trial or through an emergency treatment request from Gilead, it is recommended in the national guidelines (v3) for treatment of hospitalised patients with severe or critical disease that meet set clinical criteria.

The stated dose is 200mg on day one then 100mg daily for a total of 10 days.

Lopinavir/ritonavir, an oral antiretroviral agent licensed for the treatment of HIV, appears to have a small role in the treatment of SARS-CoV-2 infection. This combined protease inhibitor has in vitro activity against SARS-CoV and some activity against MERS-CoV in animal studies.

Guideline recommendations on its role for the treatment of Covid-19 are inconsistent, with Belgium recommending it only if hydroxychloroquine is contraindicated, and Italian guidelines recommending it as a first-line treatment in combination with chloroquine or hydroxychloroquine in patients with mild-moderate disease and as an alternative to remdesivir in severe disease.

The national guidelines (v3) recommend lopinavir/ritonavir as a second line agent at a dose of 400/100mg twice daily for 14 days for non-ventilated hospitalised patients with confirmed Covid-19 that meet set clinical criteria.

Common side effects include upper respiratory tract infections, diarrhoea, and nausea.

Hydroxychloroquine, an oral medicine licensed as a treatment for rheumatoid arthritis, lupus, and dermatological conditions caused or aggravated by sunlight, has exhibited in vitro activity against SARS-CoV-2 and other coronaviruses.

It has been the focus of widespread anecdotal use since the beginning of the Covid-19 outbreak. Hydroxychloroquine is historically easy to access and cost-effective. Whilst emerging evidence is increasingly showing a lack of significant clinical efficacy of hydroxychloroquine, it is widely recommended in European guidelines for the treatment of patients with Covid-19 either alone or in combination with other agents.

In Ireland, combination use with azithromycin is not recommended due to risk of QTc prolongation and lack of evidence on clinical efficacy.

Hydroxychloroquine is recommended in the national guidelines (v3) as a first-line agent for hospitalised patients that meet set clinical criteria at a dose of 400mg twice daily on day one followed by 200mg twice daily for a total duration of five days.

Other potential therapeutic candidates
A number of other drugs are being developed/repurposed as potential therapeutic candidates for Covid-19 infections.

Clinical features consistent with a cytokine release syndrome with elevated interleukin (IL)-6 levels have been described in patients with severe Covid-19.

Anecdotal reports have found good outcomes with the IL-6 receptor inhibitor tocilizumab, indicated for the treatment of rheumatoid arthritis, polyarticular and systemic juvenile idiopathic arthritis, and giant cell arteritis. Other contenders include systemic interferons, in particular interferon beta licensed to treat multiple sclerosis; monoclonal antibodies indicated for various cancer treatments and autoimmune diseases; and convalescent plasma therapy used back in the early 20th century for viral diseases such as poliomyelitis, measles, mumps, and influenza, and more recently in SARS, MERS, the 2009 H1N1 pandemic, and the West African Ebola virus epidemic.

Clinical trials of investigational treatments for Covid-19
More than 330 clinical trials of investigational treatments for Covid-19 are underway.

The large-scale trials documented below are adaptive in design, whereby aspects of the study protocol, including interventions, may be altered based on interim analysis and emerging evidence.

REMAP-CAP has been adapted during the Covid-19 pandemic to generate evidence on reduction of mortality, intensive care admissions, and morbidity in severely ill patients with Covid-19 infections.

To date, 90 study locations across Europe, Australia, New Zealand, and North America are participating in the study, including three Irish hospitals: Beaumont Hospital, St Vincent’s University Hospital, and University Hospital Galway.

The core trial randomises patients to multiple interventions within four treatment domains representing 240 treatment regimens: antibiotics; antiviral therapy; host immunomodulation with extended macrolide therapy; and alternative corticosteroid regimens.

Antiviral therapy comprises hydroxychloroquine and lopinavir/ritonavir.

WHO Solidarity
This trial evaluates the clinical efficacy and safety of four treatment options against standard of care for hospitalised adults with Covid-19: remdesivir; lopinavir/ritonavir; lopinavir/ritonavir with interferon beta; and chloroquine or hydroxychloroquine.

Over 70 countries have confirmed they will contribute to the trial, with many more in the process of joining. Main secondary endpoints include duration of hospital stay and time to first receiving ventilation or intensive care.

The Discovery trial evaluates the safety and efficacy of four investigational therapies in 3,200 hospitalised adults with Covid-19 across France, Belgium, Germany, Luxembourg, the Netherlands, Spain, Sweden, and the UK.

Investigational therapies include remdesivir, lopinavir/ritonavir, lopinavir/ritonavir and interferon beta, and hydroxychloroquine. The primary endpoint is clinical status at day 15.

UK trials
Priority trials in the UK include the PRINCIPLE trial for higher risk patients in primary care, the RECOVERY trial for hospitalised patients, and REMAP-CAP for critically ill patients.

United States
Two key trials led by the US include ORCHID which aims to enrol 510 participants to evaluate hydroxychloroquine for the treatment of hospitalised adults with Covid-19.

The ACTT trial aims to enrol 440 participants in 75 sites globally, predominantly in the US but also in the UK, Singapore, Mexico, and Korea, to evaluate the safety and efficacy of novel therapeutic agents in hospitalised adults with Covid-19.

Preventative measures
Vaccine development
Vaccine development timelines are difficult to predict. At present, there are 11 vaccine candidates, six in China, two in the US, one in Canada, one in Germany, and one in the UK that have entered phase I-II clinical trials with many other industries/academic institutes planning to commence trails in the near future.

The European Medicines Agency estimates it may take at least one year before a vaccine against Covid-19 is ready for approval and available in sufficient quantities to enable widespread use.

BCG vaccine hypothesis
The Bacillus-Calmette-Guerin (BCG) hypothesis, the prevalence and severity of Covid-19 correlating with whether a country has a universal coverage of BCG, a vaccine for tuberculosis disease, has emerged and attracted the attention of the scientific community and media.

The WHO does not recommend BCG vaccination for the prevention of Covid-19 due to a lack of evidence of effectiveness.

There is experimental evidence from both animal and human studies that the BCG vaccine has non-specific effects on the immune system.

These effects have not been well-characterised and their clinical relevance is unknown.

The WHO evidence review update yielded three preprints in which authors observed countries that routinely used the vaccine in neonates had less reported cases of Covid-19 to date. Such ecological studies are prone to significant bias from many confounders, including differences in national demographics and disease burden, testing rates for Covid-19 virus infections, and the stage of the pandemic in each country.

The evidence review also yielded two registered protocols for clinical trials, both of which aim to study the effects of BCG vaccinations on healthcare providers directly involved with Covid-19 patients.

Value of immunity testing
Preliminary evidence suggests some antibodies induced in those who have been infected are protective. However, it is unknown whether all infected patients mount a protective immune response and how long any protective effect will last.

Should evidence confirm that the presence of these antibodies reflects a protective immune response, serologic screening will be an important tool to understand population immunity and distinguish individuals who are at lower risk for reinfection.

Prophylactic therapy for healthcare providers/contact cases
There is currently no robust evidence to support the use of either pre- or post-exposure pharmacological prophylactic therapy for healthcare providers or those in contact with confirmed cases of Covid-19.

A number of trials are examining the use of hydroxychloroquine, chloroquine, lopinavir/ritonavir, inhaled nitric oxide gas, BCG vaccinations, emtricitabine/tenofovir, and vitamins in combination with hydroxychloroquine as prophylactic agents in Covid-19. This will help inform future recommendations.

Digital platforms
There are a significant number of Irish academics and developers stepping up to the Covid-19 call. Examples include university researchers who have developed an application tool ( which rapidly and simply tracks the spread of Covid-19 by gathering anonymous symptom data.

The aim is to enable a more accurate estimate of the prevalence of Covid-19 infections and assist authorities to make timely, data-driven decisions on protective measures. Another innovation is the development of an early warning system for the detection of Covid-19 symptoms amongst front-line Irish healthcare professionals, which currently accounts for more than one in four confirmed cases.

The Covid-19 Remote Early Warning System (CREW) identifies healthcare staff who develop a fever, a key potential indicator of Covid-19, via a wearable digital thermometer sensor and sensor platform such as a smartphone or smart watch.

The early detection of potential cases allows for precautionary self-isolation and testing thereby protecting patients and healthcare providers. An early-warning system that enables enhanced non-invasive ventilation of hospitalised patients before possible transfer to critical care has also been developed by Irish doctors.

The Accord app and a pulse oximeter determine a patients Covid-19 clinical index and predict potential intensive care intervention 24 hours prior to admission.

Another innovative solution developed by Irish researchers is a global platform to connect personal protective equipment (PPE) stock to hospitals worldwide in light of worldwide shortages. allows local organisations such as businesses, industry, universities, and laboratories to list what PPE stock they have for supply along with contact details and geographic locations.

The local hospital or clinic can click on the map of their surroundings and view what emergency PPE is in the vicinity and access it quickly.

Another Irish digital healthcare company patientMpower has partnered up with the HSE for patients enrolled in the HSE Covid-19 remote monitoring programme. Patients in self-isolation use an app to provide healthcare professionals with their oxygen saturation, level of breathlessness, temperature, and medication use.

The aims are to preserve hospital resources for those in most need, reduce exposure of healthcare providers, and enable rapid triage of patients on first signs of deterioration.

ViClarity is another company providing access to a Covid-19 outbreak preparedness audit tool for Irish nursing homes which uses HIQA’s regulatory assessment framework. Nursing homes are now required to complete a HIQA self-assessment checklist and prepare for on-site inspections.

In a rare move, Apple and Google have partnered up to enable interoperability between IOS and Android devices using apps from public health authorities.

They also plan to enable a broad Bluetooth-based contact tracing platform which would require millions of people to opt in and trust the technology safeguards.

Individuals who test positive can provide an encrypted list of phones they encountered within close proximity which trigger alerts to potentially exposed users to seek more information. Another project comprising more than 130 members across eight European countries is creating Pan-European proximity tracking technologies which ensure data anonymisation and cross-border interoperability that national authorities can use to create their own Covid-19 apps.

The HSE has also reported that a smartphone app using Bluetooth technology to facilitate contact tracing should be rolled out in the coming days.

Health Innovation Hub Ireland is working with Enterprise Ireland and other government partners including the HSE Task Force; the Department of Jobs, Enterprise and Innovation; the Department of Health; Science Foundation Ireland; IDA Ireland; Health Research Board; and the Irish Research Council to support the national Covid-19 response by collating a database of products, services, resources, expertise, and research.

Groups are invited to submit their Covid-19 solutions via an online portal. Post evaluation of legitimacy, availability, and feasibility of the proposed solutions, those of high value are progressed.

This initiative has enabled Irish healthcare to avail of Irish solutions in the management of Covid-19.

Originally published in the IMT here.

HIHI: A hub of innovation and learning

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Professor of Medicine and Director for Global Relations at the School of Medicine, Trinity College Dublin, Prof Seamus Donnelly outlines the value of the Health Innovation Hub and why education will help achieve the culture change needed in Irish healthcare

It was Steve Jobs who said: “Innovation distinguishes between a leader and a follower.” As healthcare workers, we now live in even more extraordinary and challenging times than ever before. Challenges are evolving and we must innovate and adapt. As Professor of Medicine and Director for Global Relations at the School of Medicine, Trinity College Dublin (TCD), I have a long-standing interest in health innovation and in particular evaluating early-stage technologies, assessing quality-of-life of patients remotely.

I strongly believe that the adoption of these novel technologies will change the way we practice medicine. It will empower patients and allow them to become partners in their own care. I believe that the Health Innovation Hub Ireland (HIHI), of which I am one of the principal investigators, will facilitate the evaluation and adoption of these technologies for Ireland and improve care for all our patients. It is why I became involved in HIHI.

As a joint Government initiative between the Department of Business, Enterprise and Innovation and the Department of Health, HIHI wants to look at solutions for the long term, not just get by in the short term. HIHI drives collaboration between the health service and enterprise, offering benefits to both and leveraging one another’s strengths. We offer companies the opportunity for pilot and clinical validation studies and the health service access to innovative tech and devices that they may otherwise not be exposed to. HIHI, an Enterprise Ireland and HSE partnership, bridges the divide between the health sector and the enterprise of health. We apply this mindset to all of our work.

Staff mentors

Another part to our remit is to assess ideas and concepts for healthcare innovation from healthcare staff — clinical and non-clinical. Acting as mentors and advising on taking an innovative idea and developing it into a service or product. Bringing the industry mindset to the frontline, who undoubtedly have the best solutions to our health challenges.

I know that HIHI has the potential to change how we deliver healthcare here in Ireland. The advent of personalised healthcare, precision medicine and a very informed consumer-led health sector means the old system won’t work. Those working in Irish healthcare know that although extra investment helps, there is not enough available for the shift required — this must come from us, healthcare professionals across the board. HIHI can help us achieve this.

If we want to create a sustainable culture of innovation within the Irish healthcare system, then we need to reach everybody. We need to empower problem-solvers and convert thinking into action through culture change. I believe that part of this culture change will be achieved through education. With this in mind, my role with HIHI inspired me to design a robust academic offer, which we deliver jointly as a HIHI/TCD Postgraduate Diploma in Healthcare Innovation. Our students become catalysts for innovation within the health system.

Postgraduate diploma

Sustained innovation in Irish healthcare, at an economically and fiscally responsible pace, must be a collaborative effort, requiring input from key players across the health landscape. HIHI and TCD recognise this and deliberately recruit students from both the health sector and the enterprise of health to the postgraduate diploma in healthcare innovation. Current students come from the frontline, policy, pharma and health industries. Entering its second year, the postgraduate course is now open for applications for the 2020/21 cohort. There are a limited number of scholarships available to HSE staff.

The postgraduate diploma in healthcare innovation develops innovative practitioners with the skills to identify and implement evidence-based innovative leadership practices. Focusing on future health solutions, students gain a practical understanding of applying new technologies in healthcare. Examining the role of health economics, quality improvement and the principles of governance in leading effective, innovative health services is a key learning. Critically appraising innovation theory and practice informs students’ personal approaches in applying solutions that are at the forefront of global healthcare.

Our students are supported to create a personal innovation framework that can be applied to their organisation. Our graduates are then positioned as lead architects of positive change, accelerating the healthcare system to one with innovation at its core. We need this now, more than ever. The postgraduate course culminates with modules 7 and 8 focusing on a practical project comprising two phases. We support our students to identify and plan an innovative solution applicable to each participant’s workplace that will have a positive impact in Irish healthcare.

Typically, the diploma is delivered through blended learning — face-to-face and online. If the current Covid-19 restrictions persist, the entirety of the course will be delivered online.

Culture change

One of the most exciting areas for me is the culture change, which we can engineer through education. It won’t happen overnight, but we do need to adjust and reset some approaches in healthcare in Ireland and this postgraduate course is part of that effort. Our students are confident and inspirational leaders, learning to create their personal innovation framework to apply in healthcare organisations. We want to engage right across the hospital structures and industry landscape to create a healthcare culture receptive to innovation; by teaching a new way of thinking, we will find creative solutions to health challenges.

Developing services for the frontline

HIHI has a remit from the Department of Business, Enterprise and Innovation and the Department of Health to support business development and positively impact healthcare. HIHI recognises that collaboration with business can benefit patient care, patient pathways and outcomes. The hub’s national network connects innovative healthcare products with people qualified to test them, through usability, pilot and validation studies, supporting the development of new healthcare technologies and exposing the Irish health system to the latest innovative solutions.

A central part of the HIHI remit is also dedicated to assessing ideas and concepts for healthcare innovation from healthcare staff — clinical and non-clinical. HIHI acts as mentor and advises on taking a frontline idea and developing it into a service or product. This empowers frontline problem-solvers to convert thinking into action. Additionally, to sustain a culture of innovation within Irish healthcare, HIHI delivers a programme that offers innovation workshops, roadshows and the postgraduate diploma in healthcare innovation.

This piece originally appeared in the Medical Independent here.

Irish Times series: Irish Health Innovators: Eamonn Costello, patientMpower

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Working with Health Innovation Hub Ireland, we are lucky to meet people from Irish healthcare start-ups to people on the front line that are truly innovative. Damian Cullen, the Irish Times Health Editor has agreed to share some of these in a new series ‘Irish Health Innovators’, by HIHI Dublin Manager, Eimear Galvin. Below is the second in this series.

Irish health innovator 2: Eamonn Costello, patientMpower

Eamonn Costello started his career as a telecoms engineer. A move to London brought fresh opportunities and after a time he moved into working with early stage start-ups, though healthcare was not a space where he saw himself. This changed when in 2012 his father Bill was diagnosed with pancreatic cancer. Eamonn and his fiancé (now wife) moved back to Dublin, where Eamon spent almost a year taking care of his father, much of that time spent in hospitals.

“His medication regimen would frequently change after a two week cycle – but within a two week cycle, your medication changed day by day”, Eamonn explains. This made care challenging and confusing so there was no other option than to visit the hospital for everything, even if it seemed small, just in case. Eamon saw first-hand the huge burden in the acute hospital space that can be reduced with the right support to empower patients and enable remote condition management.

The germ of Eamonn’s idea began with his father’s illness and when Bill died in 2014, Eamonn set up patientmPower with Kerril Thornhill, quickly joined by Colin Edwards who brought significant clinical experience to the company. Active in a number of therapy areas including lung and kidney disease their stand out product is a connected lung spirometer. Spirometry is a type of pulmonary function test (PFT), a non-invasive procedure that provides important information about how well the lungs are working.

“People who have undergone a lung transplant have to adapt to a whole new world where even air quality can affect their recovery.  We empower people after their lung transplant to better manage their treatment and care and enable lung transplant specialists to reliably monitor their patients’ progress remotely.”

‘patientMpower for Lung Transplant’ is the mobile platform which enables patients to keep track of everything relating to their health after a transplant and share this information with their healthcare team in real time. The aim is to remove physical clinical monitoring as much as possible. The patient has a spirometer, which they blow into that is blue tooth connected to an app on their phone. The functionality is so precise that a participant in a validation trial in Texas was able to notice early lung transplant rejection and receive the right care in the right time.

Based in Dublin’s Digital Hub, PaietntmPower undertakes a significant amount of their clinical validation work here in Ireland, with Eamonn citing Beaumont, the Mater and Galway as exceptional sites for their research, testing and product development work. However, in terms of market share and growth Eamonn sees the company continuing to target US and UK markets.  “The fact is that the Irish healthcare funding and reimbursement model does not encourage our type of solutions. In the US, there is value placed on avoiding hospitalisation that we do not currently have in Ireland. Preventative healthcare is not practiced or value based.”

From personal experience of hospital focussed healthcare delivery Eamonn and the PateintmPower team have developed a portfolio of products that empower patients through personalised remote care – which is the future of healthcare globally. Much of their portfolio is researched and developed in Ireland, tested in Ireland, with Irish patients and proven results in an Irish clinical setting. Yet the patientMpower for Lung Transplant’ is still unavailable to actively treat patients in the Irish system, outside of trial parameters.

Originally published in the Irish Times, May 14, as part of the ‘Irish Health Innovators’ series by HIHI Dublin Manger, Eimear Galvin

New Irish Times series: Irish Health Innovators – Dr Clíona Ní Cheallaigh.

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Working with Health Innovation Hub Ireland, we are lucky to meet people from Irish healthcare start-ups to people on the front line that are truly innovative. Damian Cullen, the Irish Times Health Editor has agreed to share some of these in a new series ‘Irish Health Innovators’, by HIHI Dublin Manager, Eimear Galvin.

Irish Health Innovator 1: Dr Clíona Ní Cheallaigh.

Dr Cliona Ní Cheallaigh, consultant in general medicine and infectious diseases at St James’s pioneers a unique programme on inclusion health in the hospital.  This is a dedicated service to tackle health and social inequities among our most vulnerable and socially excluded populations: the homeless, people with substance use disorders, sex workers, and prisoners. A year-long pilot study of Ní Cheallaigh’s programme showed savings of almost €1m in direct costs to the hospital and 3,066 bed stays. The programme has extended to the Mater Hospital and will now be funded as a two-year pilot by the HSE and Genio under the Service Reform Fund with national intentions.

“It’s about sitting down with people and working with them to identify and address all of their needs”, Ní Cheallaigh explains, “people who are homeless or who have addiction issues have often experienced abuse and/or neglect in childhood. This affects their ability to look after their health in many ways.  The programme  requires bringing together a wide range of people – nurses, doctors, keyworkers, hostel staff – who work in services across Dublin. “It’s not rocket science, she says, “it is just a recognition that a small proportion of people are much sicker and have a much higher need for care than the majority. The fact is that unmet needs result in people becoming sicker and needing much more costly healthcare.”

Dr Ní Cheallaigh’s  sights are now also set on establishing a voluntary group to facilitate connected inclusion health across the board. The All Ireland Inclusion Health (AIIH) forum comprises researchers, academics, clinicians, industry, HSE planners, advocates and people who have lived experience of social exclusion.  The entire group has volunteered their skills to reduce health inequity for those who are socially excluded. The challenge to achieve this is to bring these socially excluded populations into the fold. To represent them and seek to affect positive change in lives where this has often been absent.

Themes Ní Cheallaigh frequently encounters in her work are adverse childhood conditions, addiction, and sexual violence – multiple root causes, requiring a multi focussed solution. “The fact is that unless we are coordinated, connected and working together then care becomes fragmented and with the best will in the world agencies wind up working separately. We all want the people that we work with to live full and healthy lives.  Together we are stronger. That is the aim.” The AIIH will focus on advocacy, education and research and providing a support network to those working with individuals affected by social exclusion.

Although acutely aware of the need for such a forum, Ní Chealligh was stunned when 120 people turned up to the first open meeting, just before Christmas. Of that group, each individual wants to help – use their skillset, connections, expertise to establish a body that will seek to rebalance the health scales in Ireland.

The AIIH is only in its infancy and Ní Chealligh stresses that the positive outpouring belies a significant amount of practical work now required on structure, management and establishing a democratic forum that can wield influence and change across key areas. She is confident that it will get there. “People are often too quick to default to cynicism when faced with societal change. The mind-set that says ‘realistically’ it can’t be done. But look, AIIH is a practical amalgamation of experts who by powers combined are greater than individual efforts. I have no doubt this is an important milestone in tackling Ireland’s health inequity.”

Originally published: Irish Times, Tuesday May 7.


HIHI Dublin Manager, Eimear Galvin, writes about making Ireland a centre for healthcare innovation

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Access is the bedrock upon which HIHI is built. Prior to this in Ireland, the enterprise of health and the health system existed in silos. Ireland haemorrhaged healthcare industry talent as companies looked to the US and the UK for product development – countries where integrated clinical practice, education and research is the norm.  A number of years ago Health Innovation Hub Ireland (HIHI) set about changing this. Driving innovation, HIHI acts as a broker between industry and the healthcare system. At a cultural level, the hub engages directly with the healthcare community to embed innovation through support and education.

As a precursor to HIHI, as we know it today, the Action Plan for Jobs 2012 demonstrator project was formed to test at a regional level how a national hub might work. A project team based in University College Cork (UCC) delivered a demonstrator project connecting six innovative Irish healthcare companies with the health service. It provided dedicated contact points, project management, office space, advice and crucially, access to the hospital and primary care and pharmacy systems in Cork.

The six companies taking part in the demonstrator project – the first ever HIHI clients – were selected on the basis of potential efficiencies to the health system as well as the economic impact in terms of company growth, including export potential. Of the companies chosen, Radisens Diagnostics, an innovative blood-testing device, had faced difficulties in formally engaging with the HSE. Being part of the HIHI demonstrator project granted the company access to primary care, physicians, central laboratory and healthcare management. HIHI supported Radisens in their device development, offering integrated engagement with the local health service.

The ambition in the 2013 ‘Action Plan for Jobs’ was to establish a world renowned Health Innovation Hub and in doing so Ireland as a leading location for start-ups and growing medtech and healthcare companies. The demonstrator hub provided a scalable and clinically credible environment in which to launch Health Innovation Hub Ireland (HIHI) in 2016, in Cork. UCC leads a consortium of partners, Cork Institute of Technology (CIT) National University of Ireland Galway (NUIG) and Trinity College Dublin (TCD). Therein lies the genesis for the national hub expansion witnessed last year when HIHI opened doors in both Dublin and Galway, trebling its staff numbers nationally.

As a joint government initiative of both the Department of Business, Enterprise and Innovation (DBEI) and the Department of Health (DoH), funded through Enterprise Ireland and supported by HSE, HIHI recognises that collaboration with business can benefit patient care, patient pathways and outcomes. A neat example – Irish company ViClarity has a tool that monitors compliance with regulatory standards, originally designed for the financial services sector. In late 2016, ViClarity engaged with HIHI to define a pilot study in Killarney Community Hospital, focussed on improving the manual auditing and compliance measurements, within the hospital. Traditional paper based audits were built into system workflows and automated and the workflows assigned to relevant staff members within the hospital.

Staff used the ViClarity tool to complete audits, gather related data and input this directly into the system. Through the HIHI study, Killarney Community Hospital transformed a time consuming paper-based system to computer-based auditing. This means instant results, immediate compliance status visibility and ownership of audit responsibilities. The switch saved significant admin hours, freeing up staff time.  For ViClarity, HIHI secured their first clinical pilot in a public hospital. The company continues to leverage the overwhelmingly positive results of the HIHI study both in the domestic and international markets, when making the ViClarity pitch.

HIHI connecting products with people qualified to test them – industry and clinical teams – through usability, pilot and validation studies, supports the development of new healthcare technologies. Just as with Radisens and the demonstrator, multiple companies are now gaining access to invaluable insight and authoritative feedback on how their product works or may require modification. Since 2016, HIHI has managed 200 company engagements, 72 companies received follow up support and 25 HIHI studies completed in Irish healthcare settings. Each hub operates an open door policy but also issues an annual national call. Last year saw a 58 per cent increase in applications to this call, compared with 2016.

Of 70 applications, 40 made it through to the competitive pitch panels late last year, which included experts from HSE, EI, Health Research Board (HRB), DBEI, DoH, clinicians and industry. There were 25 winners and HIHI is currently matching companies with relevant clinical teams, to oversee a study of each product in an Irish clinical setting. The winning companies range from self-funded to current revenue generators. Others such as ILI – Independent Living Ireland Limited, a digital re-enablement pilot programme, which allows older people to return home sooner from hospital – have €65K seed funding from Cork County Council SBIR programme. Feeltect, a medical device company producing an adjustable, ‘smart’ compression device for venous leg ulcers (VLUs) is funded through an EI commercialisation fund and engagement platform myPatientSpace Limited won the EI competitive start up fund last year. Full list of winners here.

HIHI does not provide any funding; rather the currency is access, which is invaluable to companies developing healthcare products. Incidentally, opening up the health service to industry does not always require a full-scale study. HIHI can facilitate mid-development feedback, therapy area/market exploration, gauge clinical appetite for research partnerships, industry/clinician funding potential and focus groups. In fact, the latter is where HIHI adds value for competitive pitch winner, Feeltect. The company wants to run focus groups with its end users – community nurses – prior to embarking on a full-scale clinical trial this year. Working with HIHI Feeltect can make any adjustments now, saving time and money in advance of the trial – a costly endeavour in itself.

HIHI and its partners, not least among them the HSE, want to look at solutions for the long-term, not just to get by in the short-term. If access is the bedrock upon which HIHI is built, then the healthcare community is the fundamental component to ensure a sustainable culture change. HIHI is an open door in Cork, Dublin and Galway for staff from all parts of the health service that have ideas and solutions to problems they encounter in their work. HIHI assesses ideas and concepts for healthcare innovation from all staff – clinical and non-clinical, acting as mentors and advising on taking an idea and developing it into a service or product.

The first step is an online assessment, which will crystallise the idea. It may be a local process innovation which requires support to create the case or it may be a device or product based solution that could impact on a given therapy area and generate commercial return. HIHI will explore the idea and work it through over a six-week workshop period with each individual. At the end of this period, an idea is developed to the point of ‘next steps’. Next steps may be identifying an industry partner to build a beta product for testing, apply for an Enterprise Ireland commercialisation fund, or approach a pitch a solution to a localised challenge.

To create a truly sustainable culture of innovation within the Irish healthcare system then HIHI needs to reach everybody, not just those with product ideas and this can only happen through education. Of the four HIHI academic partners, Trinity College Dublin (TCD) has specific responsibility for the delivery of educational products that will stimulate a culture of innovation within the HSE. A connected series of five, CPD accredited, ‘Innovation Workshops’ kicked off November 2018.The workshops are open only to those working in the HSE, voluntary hospital and relevant primary care settings. Each one-day workshop has been developed to build insight into the latest thinking on practical implementation of new process ideas, new product ideas and creative approaches to re-thinking healthcare from within.

The five workshops, delivered as continuum learning, guide and encourage participants to explore the potential for innovative approaches within their own healthcare environment. Workshops 1 – 4 set the overall context for innovation and deliver hands-on, concrete learning. Participants are encouraged to identify and develop their own ideas individually or in groups throughout this period. Those who engage on this will be eligible for Workshop 5. Here participants are coached and mentored to convert their researched ideas into a coherent presentation, delivering this to a panel of healthcare leaders and experts for critique. Upon completion of Workshop 5, the HIHI ‘Certificate of Healthcare Innovation’ is awarded. The certificate recognises a “Healthcare Innovation Ambassador” and each is encouraged to develop their idea further through their local hub. The overall aim is to embed these ambassadors of innovation within the healthcare sector and build a national network of alumni who will foster an internal ecosystem of innovation and entrepreneurship within the HSE.

The second education programme is a more formal offer, open to all – a TCD Postgraduate Diploma in Healthcare Innovation, one-year course. It is anticipated that those who complete the workshop programme may well pursue the Diploma, as a natural next step. The Diploma comprises eight modules: six taught foundation modules and two project modules, including methodology workshops and a practical field project. The programme will offer fundamental grounding in key subjects: design thinking and embedding a culture of innovation; process innovation; lean thinking; social innovation and health economics; innovation and leadership. The practical project will help students to identify and plan an innovative solution applicable to their workplace, with a view to implementation. This Postgraduate Diploma will be a catalyst in transforming the innovation mind-set within the Irish healthcare landscape. Graduates are expected to lead the adoption and embedding of innovation in the Irish health system. The Diploma will run its first cohort this September 2019, with applications opening in the coming weeks. There are up to 24 places with a mix of  both open/industry and HSE places.

Our health system is sometimes seen as being a slow adopter of innovations. While there may at times be arguments for taking a cautious approach, it also means delayed patient benefits, clinical teams feel frustrated by not having access to innovative technologies and burgeoning industry is shut out. HIHI seeks to open up the health service to industry partnership through a measured and controlled system of engagement, increasing access for both sides. Simultaneously, HIHI is encouraging an entrepreneurial mind-set by providing a space and dedicated system for ideation development from within the Irish healthcare community. Through education, HIHI seeks to achieve a lasting behaviour and culture shift that ensures those in Irish healthcare are the lead architects of positive change and accelerate our system to one with innovation at its core.











Originally published in The Medical Independent – here

“Ireland is ideally placed to be a world leader in total connected health solutions” – Prof John Higgins supports #LifeSciences campaign

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One of the exciting things for us here working in the healthcare sector, is that Ireland is ideally placed to be a world leader in the provision of total connected health solutions. We have a highly networked ecosystem and the industry expertise required to embrace the convergence between health and the Internet of Things (IoT), which is the future of healthcare globally.

From improved diagnostics, to innovative prosthetics or profitable data management, the combined health and health care sector continues to show enormous growth potential.  Many of the world’s top medical technology companies have invested significantly in Ireland and a number of exciting, research-based, indigenous companies are emerging and competing internationally. In fact, 50 per cent of companies in the Irish med tech sector are indigenous.

The Irish government has identified the medical technology sector as one of the key drivers of industrial growth for the future and provides a wide range of supports to encourage and foster this growth, not least Health Innovation Hub Ireland (HIHI). Connecting new products with people qualified to test them – industry and clinical teams –  through usability, pilot and validation studies, supports the development of new healthcare technologies, in real life clinical settings.  Organising our hospital into hospital groups linked to a primary academic partner brings the right people together.

It means that companies are gaining invaluable sight and authoritative feedback on how their product works or indeed may require modification, prior to commercialisation. Simultaneously, the health service accesses products and services that they may  not ordinarily be able to use and ultimately we benefit patient care.

The move worldwide is towards personalised healthcare that empowers the patient, largely through connected health. There is unparalleled potential in this to reduce the burden on acute settings. Broadly speaking, this could mean there are less patients attending hospital and more care takes place in the community.  This is the direction that we should be taking our health service in and HIHI can help with that.

Ireland has combined exports from our life sciences and ICT sectors of over €140 billion annually.  The health service needs products to meet its particular needs and enterprise needs guidance from qualified users on developing products.  We can positively leverage the strengths of enterprise to deliver innovation into our health system, while creating an international reputation for Ireland as a leader in connected health development

Originally published as part of #LifeSciencesIE here

If we can’t change how we work in the system, the system simply won’t change.

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In Ireland today we have nine of the global top ten pharma companies and 18 of the top 25 medical device companies. Lesser known, is that we have 300 indigenous health tech companies, about 15 for each of the global.  So for every one of the big players, we have around 15 innovative indigenous enterprises. Critical Healthcare has developed a product, MediQuilt, the first-ever re-usable trolley Quilt and disposable cover a risk free cost effective solution. TickerFit, allows healthcare professionals to effectively prescribe and monitor lifestyle intervention using a web based application and passive monitoring using smartphone or wearable devices.

The exciting thing for us here working in the healthcare sector, is that Ireland is ideally placed to be a world leader in the provision of total connected health solutions. We have a highly networked ecosystem and the industry expertise required to embrace the convergence between health and the Internet of Things (IoT), which is the future of healthcare globally.

Conversely, the difficulty for us here in the Irish healthcare system is harnessing this innovation. It takes time to embrace the future and most of the medical community in this country is trying to maintain balance in our present system. No easy feat. The total spend on healthcare here is among the highest in the OECD. While our health outcomes – what we get for spending money – tends to be comparatively poor. Money, it seems is not the only answer, so in a system under immense pressure what can we do differently?

Health Innovation Hub Ireland (HIHI) was established by the Department of Business, Enterprise and Innovation and the Department of Health, supported by Enterprise Ireland (EI) and the Health Service Executive (HSE) to drive collaboration between the health service and enterprise. It offers companies the opportunity for pilot and clinical validation studies and the health service access to innovative products, services and devices that they may not otherwise be exposed to.

HIHI is built on the recognition that collaboration with enterprise can benefit patient care, patient pathways and outcomes. A simple example is that of ViClarity. Originally designed for the financial services industry, ViClarity has a tool that monitors compliance with regulatory standards. In late 2016, ViClarity engaged with HIHI to define a pilot study in Killarney Community Hospital. The study was driven by the desire to improve on the manual auditing and compliance measurements, within the hospital.

The HIHI study ran for a period of three months. Following onsite training by ViClarity the study was implemented across four units within the Killarney Community Hospital. The traditional paper based audits were built into system workflow and automated. The workflow was then delegated to the relevant staff members within the hospital. Staff used the ViClarity tool to complete audits, gather audit data and input this directly into the system.

Through the HIHI study, Killarney Community Hospital used ViClarity to transform from a time consuming paper based system to computer based auditing. This means instant results, immediate compliance status visibility and ownership of audit responsibilities.

There were at least 124 hours saved in admin time for the hospital through using the computer based system. Time that can potentially be spent on patient care.

For ViClarity, HIHI secured their first clinical pilot in a public hospital. The company continues to leverage the overwhelmingly positive results of the HIHI study both in the domestic and international markets, when making the ViClarity pitch. It has secured a high profile client base with healthcare companies such as Mowlam, MHA and most recently the NHS began using its technology solution.

One of the most reassuring services offered to hospitals by HIHI is the management process we deliver, through which companies’ engage with the health system. Once we have matched a suitable clinical team with an industry partner and both wish to pursue a study or pilot, we draw up a project scope. This project initiation document, which both parties agree, covers objectives, requirements, responsibilities and timeframe, which we oversee and manage throughout the study or pilot.

HIHI works directly with three hospital groups (South/South West, Dublin Midlands and Saolta in the West/North West), but the HIHI network can access all acute and community hospitals, pharmacies, primary care centres and healthcare centres.

HIHI and its partners, not least among them the HSE, want to look at solutions for the long-term, not just to get by in the short-term. Through HIHI we can all be allies to innovation. If we can’t change how we work in the system, the system simply won’t change.

Dr Colman Casey, HIHI National Director.

Originally published by Health Manager’s Journal:


The Irish healthcare system is in desperate need of new ideas and new solutions

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THE IRISH HEALTHCARE system is in desperate need of new ideas and new solutions to deeply embedded problems.

Health Innovation Hub Ireland (HIHI) works across the health sector with Irish businesses to creatively solve problems and improve patient care. Harnessing this innovation, through development of new healthcare technologies, products and services, will help to establish Ireland as a leading location for start-ups and will help to create Irish jobs.

The opportunity to innovate is something that we provide at HIHI. For companies, we connect products with people qualified to test them. For healthcare professionals we provide the support structures to develop ideas that will improve patient care.

HIHI will further support this innovation out with dedicated education programmes available to all HSE staff.

This week HIHI launched a double national call for businesses with new healthcare products. There is a focused call for innovations that address a specific HSE priority theme  – Enabling Positive Aging – and an open call for innovations that address any healthcare need.

The best applicants will be brought together for a Dragon’s Den style pitch in September, with the winning products fast tracked into Ireland’s health service for study. HIHI offers a powerful quid pro quo. For companies it is the opportunity for pilot and clinical validation studies and for the health service it is early access to innovative products and devices.

The total spend on healthcare in Ireland is among the highest in the OECD. Our healthcare outcomes don’t seem to reflect this level of investment. Something has to change.

Of course extra investment would help, but it’s not a panacea. The move worldwide is towards personalised healthcare that empowers the patient. For instance, TickerFit, a previous HIHI company, with a product used in cardiac rehab enables clinical teams to prescribe, educate and monitor a patient’s recovery from a distance through a wearable device.

Broadly speaking, treatments such as this could mean there are less patients attending hospital and more care takes place in the community. This is the direction that we should be taking our health service in and HIHI can help with that.

The HSE faces many pressures including a rapidly ageing population, rising incidence of long-term conditions, increased costs and budget limitations. The HSE recognises that collaboration with enterprise through HIHI can benefit patient care, patient pathways and outcomes. This is why the HSE is directly involved.

The national call is only one of several ways in which HIHI can help reform and improve the Irish healthcare system. HIHI provides an open door for staff from all parts of the health service that have ideas and solutions to problems they encounter in their work.

Anybody can contact us; our door is open in Cork, Galway and Dublin. We assess ideas and concepts for healthcare innovation from all staff – clinical and non-clinical. We act as mentors, and advise on taking an idea and developing it into a service or product.

The most worthwhile innovation in healthcare will come from the frontline. These busy people just need the opportunity and the encouragement to tap into their own expertise.

For many years now Ireland has been losing some of its most creative healthcare entrepreneurs. Places like the Mayo Clinic in the US can offer integrated clinical practice, education and research and embrace new ideas easily. They recognise the value of Irish creativity.

HIHI will do everything possible to keep these innovators and their innovations here in Ireland. We want to drive the HIHI process across the length and breadth of this country. Irish companies should be able to develop successfully within a system that nurtures and grows indigenous enterprise.

HIHI will ensure that the Irish healthcare system will test their products and services and then leverage these new products and services to the benefit of our patients. HIHI has already made significant progress. We have worked with inspiring Irish entrepreneurs in companies such as ViClarity, TickerFit, Critical Care, FastForm, Complete GP – the list goes on.

When you consider the HIHI national call, just take a moment to reflect on the possibilities that an initiative like HIHI brings. Here is an Irish grown, government backed, good news story in health with potential for change that is boundless.

Prof John R Higgins is Principal Investigator Health Innovation Hub Ireland, UCC Professor of Obstetrics and Gynaecology and Clinical Director Maternity Directorate South/Southwest Hospital Group.

Originally appeared in