Posts by: Eimear Galvin

EI Germany webinar: “How to prepare your entry into the German Market and the reimbursement process”

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DiGA Fast Track is Germany’s new, structured way for digital healthcare solutions (German: DiGA) to get access to the German statutory healthcare system, reaching more than 75 million citizens.

“How to prepare your entry into the German Market and the reimbursement process”. This will take place at 13:00 IST on Wednesday 16th September. Followed by the DiGA Summit by the HIH in Berlin (the department responsible for the fast track to reimbursement for e-health solutions) on all details about the DiGA process.

Register here: https://register.gotowebinar.com/register/8983633830961267727

Enterprise Ireland will be joined for the webinar by the team around Dr. Christoph Bischoff- Everding founder of the HGC Healthcare Consultants GmbH. HGC will cover topics like
• Chances for Irish suppliers deriving from the Covid-19 pandemic
• Market access
• DiGA
• Classification as medical device
(Watch this video to understand what the DiGA process is all about)
and Dr. Andrea Seidel from Dr. Seidel Life Science, she will discuss
• expanding your business within the German market
• Do’s and Don’ts
• what budget and timeline to consider?
• the need of clinical trials
With a wealth of experience in business development and strategic partnerships, Dr. Seidel focuses on Dr. Seidel focuses on assisting companies identify their growth potential in-market.
Statutory health insurance what the process to get listed looks like, how they learn about innovative new health apps or medical devices and what the basis for their decision is. This is important for everybody who wants to be in the German reimbursement system.
Please click here to register for the HIH DiGA Summit. DVG – A summary of Germany’s new law for digital health applications can be found here.
As places are limited, we recommend that you register in advance to secure your place.

International DiGA Summit, September 16th – insights for global digital health sellers on the German market

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On September 16th Health Innovation Hub Germany will be hosting an English-speaking “International DiGA Summit” and thus taking the opportunity to inform the global digital health communities about Germany’s ‘DiGA Fast Track’ – a pioneering process to qualify and remunerate digital health innovations in the German statutory health care system. From September 2020 on, any German physician can prescribe qualified digital health applications to >75 million German citizens, fully reimbursed by the German statutory health insurances.

Date and time September 16th from 4 – 6 pm CET

Format Fully digital, online streamed event, access via our website. Audience can post live questions via Sli.do.

Addressing Digital health providers, consultants, policy makers, investors, physicians, academics

Speakers

  • Germany´s Federal Minister of Health, Jens Spahn
  • The President of Bundesinsititut für Arzneimittel und Medizinprodukte (BfArM – German FDA equivalent), Prof. Karl Broich
  • The joint team from the German Ministry of Health, health innovation hub (hih) & BfArM who designed and are executing the Fast Track
  • High ranking representatives from NHS & FDA, as well as Hal Wolf (President & CEO HIMSS)

Register In order to get agenda and latest news in time please register via this link

Over 100 counsellors and psychotherapists sign up in three hours for telehealth pilot

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Monday, May 11: Enterprise Ireland and HSE partnership, Health Innovation Hub Ireland (HIHI), telehealth company Wellola and the Irish Association for Counselling and Psychotherapy (IACP) have launched a pilot for 103 IACP members to enable client sessions from home. Pre Covid-19 almost 100 per cent of this mental healthcare support was delivered face-to-face and now many counsellors are moving to online platforms to provide care to their clients.

The HIHI pilot provides the Wellola platform at no cost to IACP participants for six months. HIHI will then evaluate the impact of preventative, community-based mental healthcare, supported by digital tools and how online counselling compares with face-to-face therapy. Core features of the Wellola platform include:

  • Online Booking
  • Video Consultation Software
  • Secure Messaging
  • Form Completion to assist in triaging
  • Resource Sharing
  • Payment Functionalities (e-Invoicing, payment in video-screen etc)

The Wellola system offers high levels security and aims to remove structural barriers to care via its secure GDPR-compliant patient communication portal. As winners of the  HIHI national call 2019, Wellola requested the support of HIHI to explore pilot opportunities in the mental health space. Last month it was announced that the Dublin-based tech company, is providing a dedicated online portal for GPs to treat people remotely and protect against Covid-19.

Sonia Neary Wellola CEO said:

“We are delighted to be delivering this project with HIHI at a time when our citizens and care providers urgently need to find alternatives to conventional care pathways and to doing business. Wellola aims to remove structural barriers to care via its secure GDPR-compliant patient communication portal.

“We are very grateful to the IACP and its members in facilitating the study and are hopeful that learnings gained will further inform the development and application of digital tools in the mental healthcare setting”

Lisa Molloy IACP CEO said: “The IACP is delighted to collaborate on this project with the HIHI and Wellola. Our members are very keen to assist in the evaluation of how an online portal can support access to counselling and psychotherapy services

Eimear Galvin HIHI Manager (TCD) said:

“Telehealth is providing solutions to challenges right across healthcare. Although we were working on this pilot pre-Covid 19, the launch has come at the just the right time. IACP members are independent service providers whose business depends on person-to-person communication and we are supporting Wellola to explore efficacy of its portal in the critical area of mental health.”

ENDS

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.

Transmission
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.

Testing
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
Treatment
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.

Remdesivir
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
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
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
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.

Discovery
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 (mycovidsymptoms.ie) 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.

CovidMedSupply.org 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 PI and Director of the Translational Medical Device Laboratory at NUI Galway,Dr Martin O’Halloran,awarded rapid response funding

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Equipment to make it easier and safer for patients with COVID-19 to breathe

Lead Researchers: Professor Martin O’Halloran and Professor John Laffey, NUI Galway

Science Foundation Ireland award €205,667

Overview

The virus that causes COVID-19 attacks the airways and lungs, which means that people who are ill with the virus can have trouble breathing.

There are pieces of equipment to help these patients, including machines to assist their breathing, and tubes to deliver a flow of oxygen into their nose. Because of COVID-19 though, such equipment is in short supply, and in the case of high-flow oxygen, it may put the attending healthcare workers at greater risk of being exposed to the virus.

A new project led by NUI Galway called INSPIRE will develop new and easy-to-manufacture equipment to help support patients with airway problems while minimising the risk to healthcare workers.

What is the issue?

Patients with COVID-19 who are severely ill often need help to breathe, but equipment to do this is in short supply, and some may increase the risk of the virus spreading to healthcare workers.

What will the research project do?

The INSPIRE project led by NUI Galway will develop a CPAP/BiPAP Hood that can help patients to breathe and that will be easy to manufacture and reuse, and comfortable for patients to use for long periods.

For patients receiving high-flow oxygen therapy, the project will also develop a vacuum-assisted face guard that will collect infectious droplets coming from the patient’s nose or mouth during treatment, reducing the infection risk for healthcare workers.

The initiative will involve an interdisciplinary team of academic researchers, MedTech engineers, frontline healthcare professionals and industry working together to develop these technologies.

What will the potential impact be?

By developing breathing-support equipment that is easy to manufacture and safe to use for patients with COVID-19, the project will reduce risk of infection to front-line healthcare staff and may help reduce the demand on more invasive, mechanical ventilators for patients.

Dr Martin O’Halloran, Director of the Translational Medical Device Laboratory at NUI Galway, says:

This project shows what can be achieved when industry, academia and the HSE come together with a common goal of saving lives during the COVID-19 crisis. Uniquely, the Inspire team is composed of several founders of Irish MedTech companies, a team of NUI Galway researchers, and clinicians and healthcare workers from UHG. The glue holding this diverse team together is a shared commitment to making a real and tangible impact on patient care.”

Originally published by Department of the Taoiseach. Full award list 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.

Patent offices respond to COVID-19

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National patent offices, where patent applications are filed and granted, are implementing measures to reflect the rapid changes to the business environment. Recognising that timelines may be affected by these workplace shifts some allowances have been introduced.  Here KTI shares an overview of some of those extensions.  As the situation is ever-changing, we recommend that those affected visit individual office websites to confirm updates or make contact as directed. 

Intellectual Property Office of Ireland

The IPOI has announced it will remain closed from 13th March until Sunday 19th April 2020 for the transaction of business with the public.  Consequently, these days are deemed to be “excluded days” for all purposed under the Acts and Rules.

Following the Government announcement on 27th March 2020 of further measures aimed at controlling the spread of Covid 19 virus, IPOI staff working remotely will continue to maintain all of its online and e-services including e-filing of applications, electronic fee payments and email enquiries during normal working hours until further notice.  However IPOI staff will not be able to deal with telephone enquiries. For more information visit the IPOI website.

European Patents Office

The EPO is the patent office for Europe. The EPO has advised all time limits expiring on or after 15 March 2020 have been extended to 17 April 2020.  Further information on this an other implications of COVID-19 can be found on the EPO’s dedicated page relating to Coronavirus updates.

European Intellectual Property Office

The EUIPO is the European Union Intellectual Property Office responsible for managing the EU trademark and the registered Community design. The EUIPO has issued a statement extending all time limits to 1 May 2020. In practice this means time limits are extended until Monday 4th May as Friday 1st May is a public holiday.  Full details on the nature of this extension can be accessed here where any further updates are also likely to be announced.

 UK Intellectual Property Office

The UK IPO has declared 24 March, and subsequent days until further notice, interrupted days. This means that any deadlines for patents, supplementary protection certificates, trade marks, designs, and applications for these rights, which fall on an interrupted day will be extended until the IPO notifies the end of the interrupted days period. To support rights holders, businesses and IP professionals plan ahead the UK IPO will provide a minimum of 2 weeks’ notice before ending the interrupted days period. The latest news can be found here.

United States Patent and Trademark Office

The USPTO has announced extensions to the time allowed to file certain patent and trademark-related documents and to pay certain required fees. The details for patents and trademarks are quite detailed and more information is available here.

WIPO World Intellectual Property Organisation

WIPO has announced some lee way in relation to international trademark matters although extensions will not be granted automatically as is the case in other offices.  Rather WIPO users must provide sufficient evidence to excuse the delay.  On April 7, WIPO Director General  will deliver a public broadcase which will include some information on the management of Covid-19 and its impact on WIPO services and programs. For more detail visit the WIPO website.

EIT Health UKIRL call for ‘Rapid Response’ projects to address COVID-19

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“Rapid Response” Project Requirements 

• Projects should address the COVID-19 outbreak exclusively and have an “innovative” element.

• Rapid implementation of the project is required. The project should be completed, and the funding spent by the end of2020.

• The project should generate an immediate/short-term impact in fighting the COVID-19 pandemic that can be achieved and measured by the end of 2020.

• The project should generate an impact that can be scaled internationally (in Europe and globally). 

• There should be a solid scientific/technological background that should ensure the safety of patients and healthcare providers.

• The project should include elements of Knowledge Triangle Integration (e.g. university-research-business cooperationelement; research to market pathway etc). 

Please note: Vaccine and drug discovery/development are outside of EIT Health’s scope and will not be supported through the “Rapid Response”.

 

Eligibility Requirements 

Projects should:

 Include at least one EIT Health Core or Associate Partner.
 Have partners from at least one CLC/InnoStars. Note: In case of a large number of proposals, preference will be given to proposals that include partners from more than one CLC/InnoStars and have a higher impact on other regions.
 Observe the regular cost-eligibly rules of EIT-funded projects outlined in H2020 AGA.
• Observe the regular co-funding rules for “for-profit” EIT Health partners (bring at least 30% co-funding).
 External Project Partners need to be registered in one of the EU Member States or countries associated with Horizon 2020 to be eligible for the EIT funding.
• Maximum funding per project is €600,000.
Please note: 

• KCA contribution and additional co-funding will be appreciated.

• No financial contribution to EIT Health sustainability is required for the “Rapid Response” projects.

How to apply 

On-going projects that have the potential and interest to make adaptations to current work plans for rapid response are invited to first contact their respective CLC/InnoStars Directors for consultation and, if approved, submit their proposal through the online submission platform.

Proposals for new ideas can be submitted directly through the online submission platform.

Please submit proposals through the submission platform by 8 April 2020, 16.00 CET. 

We expect granting decisions on first projects by 15 April 2020 (others may follow as more budget becomes available).

 

HIHI Education – programmes update

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HIHI Postgraduate Diploma in Healthcare Innovation

The HIHI/TCD Postgraduate Diploma in Healthcare Innovation is unaffected and will continue delivering online.  If you need more information, please contact the Course Coordinator: Michelle Armstrong – michelle.armstrong@tcd.ie.

Entering its second year, the Postgraduate is now open for applications for the 2020/21 cohort. There are a limited number of scholarships available to HSE staff. More here.

HIHI Innovation Workshops

The final HIHI Workshop in the series, is postponed for now, due to the current health situation. Many of the attendees are working directly in this situation. HIHI is keen that each should have the opportunity to complete the HIHI workshop series. As a result, Workshop 5 – the presentation workshop, is postponed until further notice.

If you have any questions in the meantime: galvinei@tcd.ie

COVID-19 Rapid Response Funding Calls from Government agencies

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Research and Innovation, in health, academia and industry, have a significant role to play in the national and global response to COVID-19. Consequently, the Government’s main research and innovation agencies have developed a coordinated Rapid Response Research and Innovation programme to help mitigate and manage the COVID-19 pandemic by unlocking the potential of Irish based researchers and innovators to join the global efforts.

This coordinated response is comprised of two complementary strands. Having two focus areas allows for sufficient specialisation and coordination while optimising available resources.

  • The first focus area targets medical countermeasures, health service readiness, and social and policy countermeasures to COVID-19. This is led by The Heath Research Board and the Irish Research Council. Details of the call can be found here.
  • The second focus area is an agile and adaptive initiative to combine the capabilities of industry and academia in the development of innovative solutions that can have a rapid demonstrable impact on the current COVID-19 crisis in Ireland. This is led by Science Foundation Ireland, Enterprise Ireland and IDA Ireland and details of the call can be found here.

The agencies will work in partnership to coordinate applications and ensure a seamless and agile review and funding process, with the progress and results from each stream shared broadly. As the calls operate under a single programme, applications will be aligned by the agencies to the most appropriate call.

In dealing with the COVID-19 crisis, pace is critical and research funders around the globe have mobilised rapidly to provide a range of opportunities for researchers and innovative companies. The Rapid Response Research and Innovation funding proposal is an invitation to researchers and innovators in Ireland to support the efforts to reduce the impact of COVID-19.