Interview https://thejournalofmhealth.com The Essential Resource for HealthTech Innovation Wed, 26 Mar 2025 11:34:34 +0000 en-US hourly 1 https://wordpress.org/?v=5.7.12 https://thejournalofmhealth.com/wp-content/uploads/2021/04/cropped-The-Journal-of-mHealth-LOGO-Square-v2-32x32.png Interview https://thejournalofmhealth.com 32 32 The Role of Digital Nurses in Transforming Healthcare https://thejournalofmhealth.com/the-role-of-digital-nurses-in-transforming-healthcare/ Mon, 31 Mar 2025 06:00:37 +0000 https://thejournalofmhealth.com/?p=13996 Q&A with Judy Sealey, former nurse and clinical solutions specialist at Altera Digital Health Judy Sealey, clinical solutions specialist at Altera Digital health discusses the...

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Q&A with Judy Sealey, former nurse and clinical solutions specialist at Altera Digital Health

Judy Sealey, clinical solutions specialist at Altera Digital health discusses the evolving role of digital nurses in health and care and explores why their roles are so important.

For background, digital nurses are registered nurses who already have a wealth of clinical experience and have developed expertise in using digital technologies to improve patient care. They bridge the gap between traditional nursing practices and the modern digital healthcare landscape, ensuring technology is effectively integrated into clinical workflows to standardise and streamline processes to improve patient safety and enhance their healthcare journey.

How and why did you make the transition into digital nursing?

Judy Sealey: I have worked in the NHS for over 15 years mostly in emergency department (ED) and critical care (ICU) nursing, I have also dabbled a bit in specialist fields like infection control, tissue viability and cardiology as I searched for my true passion. At one time, nursing education was where I thought my passion lie however, it was whilst I was a clinical educator in an ICU that was using an EPR that my passion for digital healthcare technology blossomed. I started off by making suggestions for optimisations, becoming more involved in refining some of the workflows and ensuring that staff were adequately trained and comfortable using the system, this led me to a variety of other opportunities and experiences.

For the last thirteen or so years I have taken on several roles within this space with my greatest passion and desire being continuous improvement to healthcare delivery and the huge role digital systems plays in this. I know first hand the challenges of excessive repetitive documentation, time wasted searching for patient paper records, inefficient and clunky digital tools and workflows. I leverage my nursing expertise and wealth of digital skills to advocate for more user-friendly designs, less complex workflows that will enhance patient care and reduce clinicians’ burden and burnout.

How do digital nurses affect patient care and outcomes?

JS: Nurses are the largest workforce in health and care and are therefore the primary users. Digital nurses bring a unique skill set to the table. They leverage their clinical knowledge and expertise to enhance digital tools like electronic patient records (EPRs), mobile health apps and telehealth platforms. By doing so, they ensure the system is user-friendly, practical, efficient and safe. For example, at Bolton NHS Foundation Trust, collaboration between digital and clinical teams has significantly improved patient safety through better EPR configuration and optimisations.

It sounds like collaboration is key. Can you tell me a bit more about what happens when there’s a disconnect between clinical and digital teams?

JS: Unfortunately, that disconnect can be traced to a reluctance among clinical teams to embrace technology. Without clinical input, digital solutions may lack the context needed to be truly effective, which can disrupt workflows and compromise patient safety. That’s why digital nurses are essential—their input at every stage of the project ensures collaboration and bridges this gap, ensuring the creation of a system that enhances patient care and patient safety while improving efficiency.

How can healthcare systems better support digital nurses and foster collaboration?

JS: To truly support digital transformation, we need to invest in the digital nursing profession to ensure nurses have the necessary training, skills and dedicated time to be successful in this very important role. Digital nurses should be involved in all patient-facing digital projects, from planning, testing, training to delivery and optimisation. Nurses, being on the frontline, are uniquely positioned to identify service gaps and act on opportunities to make impactful changes.

NHS England’s National Chief Nursing Information Officer (CNIO) advocates for CNIOs in every NHS organisation. What’s your take on this?

JS: That’s a fantastic initiative. CNIOs are essential for every hospital because they play a vital role in ensuring the nursing perspective is represented in all aspects of digital health and care transformation. It underscores the importance of nursing leadership in driving the digital agenda and aligns with the goal of embedding digital nurses in all areas of care delivery. Crucially, the CNIO bridges that gap between clinical and digital teams, translating nursing needs into technical requirements and ensuring technology truly meets the needs of supporting patient care.

Looking ahead, what role do you see digital nurses playing in the future of health and care?

JS: As health and care continues to evolve, digital nurses will play a central role in driving the change in successfully navigating the future of digital healthcare. They will become more involved in the entire process, from selecting the most suitable digital solutions, to designing, implementing, testing, training and, indeed, optimising them. From EPR rollouts to telehealth projects and beyond, they’ll be key in ensuring that digital transformation truly meets the needs of frontline staff and continuously improves patient outcomes. Their involvement will drive innovation, improve patient safety and create efficiencies across the board.

Do you have any final thoughts for organisations looking to embrace the digital nursing profession?

JS: Yes, invest in your nursing workforce and be sure nursing curriculums include some aspect of digital training. Involve digital nurses in all patient-facing projects and make collaboration between clinical and digital teams a priority.

Without this, organisations risk digital transformations that compromise patient safety, hinder rather than supports care and increase nurses’ workloads, which can contribute to burnout. An approach that embraces the involvement of digital nurses will drive effective inter-organisational collaboration that will help unlock the full potential of digital transformation and ensure it delivers real value to patients and staff alike.

Thank you for those insights. It’s clear that digital nurses are vital to the future of health and care.

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How Connected Cloud-based Platforms are Advancing Quality in Biopharma Manufacturing https://thejournalofmhealth.com/how-connected-cloud-based-platforms-are-advancing-quality-in-biopharma-manufacturing/ Fri, 06 Dec 2024 06:00:00 +0000 https://thejournalofmhealth.com/?p=13721 Robert Gaertner, Vice President of Quality Strategy Europe at Veeva Systems, discusses the growing importance of connected platforms in ensuring quality in pharmaceutical manufacturing and...

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Robert Gaertner, Vice President of Quality Strategy Europe at Veeva Systems, discusses the growing importance of connected platforms in ensuring quality in pharmaceutical manufacturing and the shift toward personalized medicine.

Nowhere is quality more important than in healthcare. What challenges do biopharmas currently face in maintaining high quality?

There are many challenges in the pharmaceutical industry, and quality is a critical factor. Patients must trust that medicines are safe, meet high standards, and comply with regulations. With personalised medicine and other modern therapies, this becomes even more challenging. Unlike traditional medicines distributed through pharmacies, personalised therapies require extra layers of quality control. A good example is the public discussion around vaccines during the COVID-19 pandemic. People knew some vaccines had to be refrigerated, but they likely didn’t understand the extensive effort required. You can produce a high-quality medicine, but for it to remain safe and effective, you must monitor it until it reaches the patient. The more personalised the therapy, the more crucial this becomes.

How does Veeva help biopharmaceutical companies maintain quality?

There has been a significant shift in recent years. In the past, companies manufactured and tested medicines in-house. Now, manufacturers must pay more attention to the quality of their suppliers, and logistics plays a growing role as more of it is outsourced. While some companies specialise in logistics, the manufacturer remains responsible. This shift requires solutions that not only manage internal business processes but also integrate the entire supply chain, including partners. That’s why cloud-based, industry-specific solutions like Veeva Vault Quality have become critical. Cloud technologies play a key role in maintaining quality because companies need to communicate with suppliers and partners—and even patients—in real-time. This requires easily accessible, secure, and traceable data, all while staying compliant with regulations like GDPR.

Where do connected cloud platforms help the most, particularly with transparency?

Here’s an example: when a raw material is produced in another country, the quality decision requires approval based on the data the company receives. If this data is handled on paper, it causes delays. Connected cloud platforms provide real-time insights, and they ensure data integrity. With cloud solutions, everyone in the supply chain can access the same data simultaneously, reducing redundancies and improving decision-making.

How does Veeva help keep data entry clean and secure?

You have to look at the entire supply chain. In production, for example, some machines have sensors that provide data relevant for quality decisions. Another example is patient complaint management. If a patient experiences side effects, a doctor or healthcare professional enters this data manually. Ideally, they only need to enter it once, and the system ensures secure entry. Artificial intelligence can help ensure data is entered correctly, and quality checks can occur as soon as data is available. Connected cloud technologies, like those from Veeva, also bring together different data sources, whether from other digital systems or manual inputs, to maintain quality control.

Has Veeva developed a streamlined way to achieve this?

Yes. Veeva’s Quality applications are scalable and easy to access online. Companies can define which groups of people need convenient access to the database, and we can configure the system accordingly, always adhering to security requirements.

Looking to the future, what challenges could the industry better address in the next three to five years, possibly with AI? 

There’s a constant tension between efficiency and compliance. Regulations must be met, but at what cost? The key for the pharmaceutical industry is balancing GxP compliance with streamlining quality systems to improve both cost-efficiency and quality outcomes. The focus should shift from managing quality issues to preventing them. AI can help predict potential risks and prevent them before they occur. Additionally, the definition of a pharmaceutical product will evolve. We often think of medicine as a pill or physical product, but future therapies will be more complex and personalised. Homecare and clinical trials are moving from hospitals to patients’ homes, where wearables will report data. This brings new quality challenges, such as qualifying devices and validating processes, which are easier to manage with cloud solutions.

What does the industry expect from Veeva in this regard?

We develop our solutions in collaboration with our customers. We aim to understand their challenges and work with our experts to develop innovative solutions that align with their needs. It’s a combination of customer input and our strategic vision, alongside regulatory requirements, particularly in the area of quality.

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Advancing The Market Launch of Innovative Medical Devices https://thejournalofmhealth.com/advancing-the-market-launch-of-innovative-medical-devices/ Wed, 13 Nov 2024 06:00:00 +0000 https://thejournalofmhealth.com/?p=13620 What challenges do MedTech companies face when introducing their solutions to the NHS? We often find that MedTech companies don’t understand what their value is...

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What challenges do MedTech companies face when introducing their solutions to the NHS?

We often find that MedTech companies don’t understand what their value is to the NHS. At Health Analytical Solutions, we help them navigate the process of delivering a solution for the health service that it will value, building the relationship beyond that of simply a supplier.

Health services tend to – understandably – be extremely risk-averse and cautious. MedTech companies need to demonstrate significant compliance with high standards of care over long periods, as well as demonstrating a solution is materially more beneficial to a patient than the current standard of care (SOC). MedTech can act as a bridge between overworked health services that are struggling to cope with ever-increasing burdens from an ageing population and have the potential to completely change how healthcare is provided.

How important is achieving Drug Tariff status for MedTech companies?

On a monthly basis, NHS Prescription Services produces a Drug Tariff on behalf of the Department of Health and Social Care. This is supplied primarily to pharmacists and GP practices and outlines what will be paid for NHS services that are provided for reimbursement or remuneration. For MedTech businesses, who are developing products to be used outside of the hospital, getting approval to be included on the Drug Tariff is  a critical step in enabling widespread adoption of their product within the UK health system.

In the past there was often a situation where – if a company could tick some boxes to demonstrate the ability to help address medical conditions, the company could achieve Drug Tariff status.  However, this has changed now and is more in line with a HTA Health technology Appraisal process, which has a high barrier to entry.

What do companies need to consider when preparing to submit Medtech products to the Drug Tariff in the new world?

MedTech companies need to have all the right information and insight available right from the start as there are always things you don’t see coming. As a result, that requires us to work with companies to generate new information quickly to avoid slowing the process.

The metaphor I use is that this process is like an expedition. Companies need to be fully prepared.  It’s not helpful to get halfway up a mountain and find you’re missing a key piece of equipment.  Companies can save time and money by being fully equipped with the right information before embarking on NICE or Drug Tariff submissions. The challenge is that Drug Tariff often changes what is required, so flexibility and being agile is key.

What is an example of an innovative MedTech device you have previously worked with?

Since founding Health Analytical Solutions, we have worked on over 140 medical devices, I have had the opportunity to work with numerous Medtech devices helping them to access the NHS market. During this time, one innovation that has stood out is the geko™ device. Developed by Sky Medical, it is a wearable, battery-powered device that is the size of a wristwatch and worn at the knee. Using Sky Medical’s patented OnPulse™ technology, the geko device gently stimulates the common peroneal nerve activating the calf and foot muscle pumps, resulting in increased blood flow in the deep veins of the lower leg equal to 60 percent of walking without a patient having to move.

The geko™ device is NICE approved for unmet need VTE prevention, when standard of care cannot be prescribed, and is clinically proven to prevent life-threatening blood clots, accelerate wound healing (leg ulcers), and is indicated to treat and prevent pre and post-operative oedema.

Last year, the International Wound Journal published the company’s multi-centre randomised self-controlled trial (RCT). The study compared SOC with and without the geko™ device in patients with VLUs, while demonstrating an acceleration in the rate of healing by more than double in patients treated with the geko™ device versus SOC alone.

How did Health Analytics Solutions demonstrate the cost-effectiveness of the geko device?

The use of the geko™ device in addition to SOC has a significant positive outcome, so this enabled us to build an economic model using NHS data. We were able to establish quite quickly that any NHS Trust using this device would make savings in this therapeutic area.

Much of the cost saving was around hard-working district nurses, who regularly visit VLU patients. With the workforce being reduced by nearly 50% over the last decade, supporting them presents a huge benefit to the system. A further saving was on consumables such as compression bandages.

My team helped Sky Medical devise a strategy where clinicians could assess – after 28 days – whether a VLU was on the right trajectory to heal or not. Where patients were either experiencing very slow healing or no healing at all, the geko™ device could have a significant impact on health economics instantly.  We could be talking of a reduction of several weeks in healing time.  With a district nurse visiting two or three times per week at a cost of £40 a visit, the benefits of the product quickly add up.

What does the future of MedTech look like in the NHS and the wider healthcare industry?

Everyone knows the challenges caused by the ageing population and the backlogs in treatment. I think the waiting lists will continue to grow towards eight million, but I’m excited that healthcare driven by technology and – particularly – Artificial Intelligence (AI) can help address future challenges.

AI will certainly help to reduce human resources looking at X-rays, scans and the like, helping radiologists reduce their workload. In the next two decades, we are going to see some radical changes in line with the biggest seismic shifts in healthcare ever to take place.  Imagine the impact AI could have around some of the world’s biggest health challenges such as cancer, neurological conditions, diabetes and many others.

By Richard Tuson CEO and founder of Health Analytical Solutions

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A Three-point Plan for Digital Delivery https://thejournalofmhealth.com/a-three-point-plan-for-digital-delivery/ Fri, 28 Jun 2024 06:00:00 +0000 https://thejournalofmhealth.com/?p=13200 Sam Shah has seen health tech policy up-close and worries that little progress has been made over the past five-years. However, he has a plan...

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Sam Shah has seen health tech policy up-close and worries that little progress has been made over the past five-years. However, he has a plan for any health and social care secretary who’d like to solve problems instead of issuing sound bites.

Sam Shah has a very diverse portfolio: spanning clinical work, academic leadership, legal advice, and health tech advisory roles that see him travelling from the UK to the Middle East and back.

Shah has developed this diverse range of interests since he left NHS England and then NHSX, where he was director of digital development. So, he has excellent insight into the progress the NHS is making on digital – and he doesn’t think it’s great.

Lots of noise, very little action

“I do not think health tech has moved forward for the past five years,” he says. “There has been a lot of talk, a lot of initiatives, but very little activity. There have been five changes of leadership at NHS England on digital in the past five years, and a lack of transparency about what they have been doing.

“The digital maturity assessment [that was supposed to underpin the frontline digitisation programme to implement and expand electronic patient records] has never been published in full.

“NHS England says 90% of trusts have an EPR, but […] that statement is meaningless unless you have a definition, or can say how things have changed over time, or whether these tools are being used, or what difference they have made.

“The cost isn’t clear because it’s subject to constant reassignment. And even though the last Budget made another announcement on funding, there is no programme, no proper senior responsible officers, to spend it.”

In fact, he argues, Wales, Scotland and Northern Ireland have all made a lot more progress for a lot less noise by creating teams with clear digital responsibilities, allocating them a budget, and letting them run “small, useful” programmes in collaboration with their healthcare systems.

A three-point plan for progress

The UK is almost certain to go to the polls for a general election this year and it’s almost certain that Labour or some version of it will be voted in. Shah knows exactly what he would like shadow health and social care secretary Wes Streeting, who likes to talk about “reform” and apps, to do.

“He should establish a strategy, aligned with the system – which means industry partners as well as people working in healthcare,” he says. “He should pick three things to do well, and find the budget to do them, but delegate it so people don’t have to keep going back to the centre.”

And what three items would be on Shah’s wish list? “Number one would be to make it easier for clinicians to collaborate with other clinicians,” he says. “Not just referrals, or sending people from GP surgeries to hospitals, but the co-ordination of care across the system, or what we used to call ‘any to any’.”

This would not just smooth care pathways, he adds, but Amazonify healthcare. Just as people can use apps to track their parcels and modify their deliveries, they’d be able to see where they are in the healthcare system and make choices accordingly. Health is complex but decent platforms would make things a little easier.

“The second item on my wish list is to sort out the data environment,” Shah continues. “That doesn’t mean putting in one EPR, but making data fluid, so we can sort out data for our planning and our public health and our research colleagues.

“And the third thing would be to sort out the front end: whether that’s the frontend for clinicians or for patients.” Shah says this means modern, mobile technology that makes it easy to do basic tasks, like putting together a patient list, or viewing a series of appointments on a calendar.

Not lots of apps. “Clinicians are getting app fatigue from being told to download this and login to that,” he says, “and we don’t want to start giving our patients app fatigue as well. They are much more likely to want one login and one place to see everything, end to end as far as the NHS is concerned.”

Sort out today’s problems, then see what AI can do

Interestingly, Shah’s wish list doesn’t include AI, even though it seems to be compulsory for Streeting and other politicians to claim that it will solve all the NHS’ problems. “AI is interesting,” he says, “and everybody is interested in generative AI in particular, but we need to get the basics right.

“We need to solve today’s problems and then start layering in AI, when it’s mature enough, and we know which of tomorrow’s problems it’s going to help us with.”

Instead, he has costed his wish list – he reckons it would cost around £4.7 billion over the first three years of a five-year programme. After that, there might need to be some “top ups” – although he argues his wish list would deliver efficiency savings.

For example, a transparent and efficient referral system would reduce the need for referral administration and cut the number of GP appointments that are made by patients desperate to find out what has happened to their test or trip to outpatients.

Better data could help public health and its partners in local government to get back to addressing some of the inequalities, determinants of health, and lifestyle choices that drive demand at a fundamental level. And some nifty administrative tech could deliver significant efficiencies.

“I see in my own practice that people are in pain, so they ring a call centre for an urgent appointment but it’s made at a centre they cannot get to, at a time they can’t make, so they don’t turn up,” he says. “It really should be possible to stop that happening.”

Soundbites and spin doctors  

Still, Shah is not exactly confident any of this will happen. Having seen some politicians at close hand, he feels they’re looking for soundbites to deliver to their electorate.

“They don’t want practical or costly. And this is practical and costly,” he sighs.” Those of us who have been in the system: we can say the right thing and not worry about it being the popular thing. But most politicians aren’t in that position.”

This might be an argument for following the lead of Wales and, to some extent, Scotland, and creating an arms-length body to plan and deliver NHS IT. Or, perhaps, to re-create one, as the NHS in England has tried a similar idea before, with the NHS Information Authority, and then NHS Digital, and NHSX.

Shah feels the idea has merit – but the fate of these bodies shows there are pitfalls. “There is no doubt that NHS England has got too big and there is an argument for breaking it up again,” he says. “But you should only do it if you can find the right model, and the right leaders.

“It can’t be like NHSX, where the friend of a politician was parachuted in, and created a circus before he went off to the zoo [NHSX boss Matthew Gould eventually departed for the Zoological Society of London].

“You need a good operator, who understands the NHS, but knows how to run a major programme and handle a big budget. If you can’t find one, you shouldn’t bother.”

Finding causes for optimism

And if Streeting did come knocking, would he be tempted to go back? Shah laughs. “Only if he liked my plan and could accept a dose of reality,” he says. And only if the right team was appointed, and promised the space to build, implement and deliver products.

Still, he says, there are reasons for optimism about health tech. “I think there is a commitment to improve access to healthcare for society, and I think it is recognised that inequalities have widened and there is a need to address them” he says.

“So, there is an opportunity for digital, which is to bring data together to help clinicians to do the job, and to help planners make better public health decisions. And, of course, to be more transparent with the public. I think digital and data can get into quite an interesting space, and there is an opportunity to do it.”

 

Biography:

Professor Sam Shah  works in digital health across the College of Medicine and Dentistry with Ulster University and is visiting faculty at UCL and UCLan. Sam works clinically in primary care and is an NHS consultant at the Royal Wolverhampton NHS Trust. Sam was previously chief medical strategy officer for online healthcare provider Numan. He works with a number of organisations in health tech, supporting development of ecosystems. He has a particular interest in health tech regulation, public health and behaviour change.

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Understanding the Healthcare Cybersecurity Problem https://thejournalofmhealth.com/understanding-the-healthcare-cybersecurity-problem/ Wed, 01 May 2024 06:00:00 +0000 https://thejournalofmhealth.com/?p=13049 Anurag Lal is the President and CEO of NetSfere, and an expert on global cybersecurity innovations, policies, and risks. With cybersecurity now a major issue...

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Anurag Lal is the President and CEO of NetSfere, and an expert on global cybersecurity innovations, policies, and risks. With cybersecurity now a major issue for all healthcare providers, we asked Anurag for his analysis and understanding of the threats facing the industry and how organizations can best adapt to these challenges.

What are common security issues healthcare enterprises deal with regularly?

Digital transformation has taken over all industries, especially in healthcare. These organizations hold the personal, sensitive and valuable information of hundreds of patients, making healthcare entities a large target for bad actors. Some of the security issues in healthcare include ransomware, phishing, malware and data breaches. Healthcare organizations need an increased understanding of the threats facing them and they must recognize the need for top-of-the-line cybersecurity practices, including deploying end-to-end encrypted technology platforms as a line of defense against these security threats.

How is cybersecurity playing a role in the healthcare industry?

Cyberattacks continue to plague the healthcare sector as criminals work to gain access to sensitive patient data. According to The HIPAA Journal, 24 data breaches of 10,000 or more healthcare records were reported to OCR in January 2024 alone, including one breach of half a million records, one of more than 2 million records, and a breach that exposed the records of almost 4 million individuals.

Healthcare organizations are excited about the power of technologies and their use to optimize workflows and inject efficiencies into operations. However, there are risks to consider when using different platforms, including, privacy standards, security protocols and compliance adherence. This includes emerging generative AI and messaging platforms.

How does HIPAA compliance impact the healthcare industry?

The Health Insurance Portability and Accountability Act (HIPAA) establishes standards and requirements for handling protected health information (PHI) and electronic protected health information (ePHI). Protected health information is any information that can be used to identify patients or clients such as names, addresses, Social Security numbers, phone numbers, medical records, and financial information. Data breaches in this sector are on the rise as cybercriminals increasingly target healthcare enterprises to gain access to vast amounts of PHI, and it’s essential healthcare entities are protecting their patients.

Without HIPAA-compliant mobile messaging and technologies, patient data is vulnerable to unauthorized use and disclosure. By implementing an enterprise-grade business communication platform that meets all HIPAA standards and requirements, organizations can improve their overall security posture and reduce the likelihood of breaches and violations.

Why is it important healthcare enterprises prioritize secure communication?

Collaboration tools are mission-critical for enabling real-time, contextual communication to improve clinical communication and streamline workflows in healthcare organizations. Implementing encrypted communication platforms will eliminate the unsecure gaps in the flow of communication and facilitate protected collaboration, translating to improved staff and patient experience and better clinical outcomes. Effective communication will support care teams and ensure safe, high-quality patient care, working to optimize communication, which can free up physicians and care teams to spend more time with patients and significantly reduce medical errors. It will also reduce the risk of data breaches, ransomware and fines from the FCC for not meeting HIPAA compliance.

What tips can you provide healthcare entities on implementing safe and secure communication and avoiding cyber risk?

Healthcare entities must be aware of the technologies or platforms they’re using, specifically, the risks and compliance issues that lie within them. With precious, sensitive information, the healthcare industry should be implementing technologies with true end-to-end encryption that are HIPAA compliant as a basic standard for all software where sensitive information is shared.

Another best practice for healthcare entities always goes back to human error. Regular cybersecurity training is a must for employees who are increasingly targeted by cybercriminals. Ensuring staff have a clear understanding of cybersecurity issues will help them identify threats or vulnerabilities throughout the organization and patch up those weak spots. With regular training, employees can become a powerful defense against cyber threats.

 

Anurag Lal is the President and CEO of NetSfere. With more than 25 years of experience in technology, cybersecurity, ransomware, broadband and mobile security services, Anurag leads a team of talented innovators who are creating secure and trusted enterprise-grade workplace communication technology to equip the enterprise with world-class secure communication solutions. Lal is an expert on global cybersecurity innovations, policies, and risks.

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Fixing Your Approach to Population Health Starts with Actionable Data https://thejournalofmhealth.com/fixing-your-approach-to-population-health-starts-with-actionable-data/ Tue, 30 Apr 2024 06:00:00 +0000 https://thejournalofmhealth.com/?p=13045 Viki Field, RN, MSN, is a program manager for Chordline Health, the leading provider of fully integrated workflow and analytics software for managed care. She...

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Viki Field, RN, MSN, is a program manager for Chordline Health, the leading provider of fully integrated workflow and analytics software for managed care. She has nearly three decades of experience in managed care, utilization management and the ability to leverage data to strengthen population health. We spoke with Viki about how the right approach to population health analytics is vital in managing healthcare utilization and driving better outcomes for all.

When it comes to managing population health, what’s holding healthcare’s key stakeholders back?

It’s hard to manage what you don’t understand. Often, health systems and health plans encounter blind spots when it comes to a patient’s health needs, from whether the patient is taking medications as directed to the social determinants of health (SDOH)—from housing insecurity to lack of access to healthy food—that affect health outcomes.

Research shows 52% of U.S. adults have at least one SDOH risk factor, and patients with certain chronic conditions, such as diabetes, feel the impact of SDOH more intensely. For example, adults with diabetes typically face high rates of food insecurity, which is disturbing given the potential for food to serve as medicine for blood sugar control.

Yet health systems and health plans struggle with inconsistent approaches to SDOH data capture. And even when they do have access to information regarding a community’s SDOH risk factors, they lack the population health analytics to dig deeper. Such capabilities are crucial when it comes to managing healthcare utilization, such as by helping people with chronic disease avoid unnecessary emergency department visits and avoidable hospital stays.

It sounds like the challenge starts with access to data. Could you talk about the barriers health systems and health plans struggle with in gaining access to comprehensive information regarding patients’ health needs?

Healthcare organizations sit on mountains of data, yet they struggle to leverage this information to pinpoint which patients are most at risk, gain a big-picture view of their population’s social needs and respond in ways that improve population health.

Today, 80% of healthcare data is unstructured, which means it isn’t directly available to clinicians through their workflows, such as via the EHR. This type of information includes handwritten notes, open-note fields in the electronic medical record, faxes and images. Without the capability to transform this information into structured data and analyze it, healthcare organizations lose vital opportunities to determine health needs by population and by individual.

It also takes trust for patients to share sensitive information that could impact care decision making with their provider. A survey by the Office for the National Coordinator (ONC) for Health Information Technology—shared during the ONC’s annual meeting this past December—found four out of 10 people are not comfortable sharing SDOH. Some patients fear the data will be used against them. That’s why it’s critically important that providers share why they are asking for information around social determinants and how they will use this information. The more a patient trusts their physician or clinician, the more likely they are to share information regarding their SDOH needs.

But there are also missed opportunities for health systems and health plans to collaborate with each other to uncover gaps in patient’s health needs. For instance, by sharing claims data with providers, payers can help clinicians see whether a patient is adhering to their medication and visiting a recommended specialist. With this comprehensive view, clinicians can then develop targeted health interventions that matter.

Once providers and health plans have the right data in hand, how can they use it to improve population health and address utilization management more effectively?

The value of access to SDOH factors becomes diminished when healthcare organizations can’t use it to pinpoint where the greatest needs exist and design a plan for better outcomes at reduced cost.

It starts with the ability to incorporate data from a wide range of systems and sources. Once these data “speak the same language,” advanced population health management software can provide a next-level view. Such software can help identify patients’ health status, pinpoint opportunities to strengthen chronic care management, and make it easier for health systems and health plans to identify and respond to risk.

The right managed care platform will empower clinicians to identify risk areas at the individual and community level and strengthen their ability to respond in the right ways at the right time. It will describe and predict a population’s past or future utilization of healthcare services and their associated costs. Perhaps most important, it will deliver analyses that clinicians can understand at a glance.

What are the keys to making population health information actionable for those on the front lines of care?

We’ve found that seamless access to actionable population health data—delivered directly within clinicians’ workflows and in an easy-to-read view—makes a significant difference.

It starts by adopting intuitive dashboards that put population health information at clinicians’ fingertips. This at-a-glance view makes it easy for clinicians to spot trends that prompt cause for concern, such as the top 10 drugs prescribed to a given population over the past year and the lead indicators for unexpected pharmacy costs.

The most advanced population health platforms also leverage predictive analytics to project risk by population and by member—and offer insight into right-now actions that could make a difference.

At Chordline Health, our ability to link SDOH with a predictive modeling program designed by Johns Hopkins gives clients access to a regional and national view into health risks. With this information, health systems and health plans can evaluate where they stand when it comes to the health of their population and their ability to mitigate risk. They can also leverage learnings from peers on ways to strengthen support for better health. These actions ultimately reduce utilization management and healthcare costs by ensuring the right care is accessed at the right time and in the right settings.

In your view, once healthcare organizations are on a path to success around analytics for population health management, how can they sustain these gains?

Ultimately, innovation around population health management, including data-informed innovation, must translate at scale. To get there, healthcare organizations must have a clear vision of what they want to achieve and how. As one panelist shared during ViVE, “If you have a really clear understanding of the direction that you want to go, where you’re aiming toward, and the foundation you want to build, then you’re going to be able to make much better decisions.” It’s time for healthcare leaders to create a vision for population health success and invest the right data tools and resources to make a broad impact.

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Pete Heydt of PatientPay Discusses the Benefits of Mobile Payments in Healthcare Financial Strategies https://thejournalofmhealth.com/pete-heydt-of-patientpay-discusses-the-benefits-of-mobile-payments-in-healthcare-financial-strategies/ Fri, 15 Mar 2024 06:00:00 +0000 https://thejournalofmhealth.com/?p=12946 Pete Heydt is the President of PatientPay, the leading patient payments partner for acute, ambulatory, and specialty care groups. We spoke with Pete—a veteran leader...

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Pete Heydt is the President of PatientPay, the leading patient payments partner for acute, ambulatory, and specialty care groups. We spoke with Pete—a veteran leader in the healthcare payment technology market—about how medical groups can survive periods of economic instability and create more positive patient financial experiences. We also discussed the benefit to providers and patients when organizations incorporate mobile payment into their overall financial strategy. 

With healthcare organizations recently recording the worst financial year to date due to inflation and labor shortages, many had established new techniques for patient financial engagement. In your expert opinion, what are some ways organizations can overcome these challenges? How important is it to include digital communications and payment options into the patient financial engagement process?

Providers do not have control over inflation or labor shortages, which can both greatly impact their bottom line. What they do have control over is how they can increase collections with the right approach to patient financial engagement. Digital communications and payment strategies are essential to getting this right. This means providing seamless, convenient access to the financial information patients need.

Above all else, billing and payments need to be easy to understand and execute for patients. Patients want to pay their bills, but there is often confusion around what is owed and why. If you can clearly communicate this information to patients, you’re ahead of many healthcare organizations out there today. Medical groups provide excellent clinical care, but a substandard financial experience, which significantly affects the overall patient satisfaction. More than half of patients say a negative financial experience has motivated them to leave a bad review of their provider. The key to fixing this isn’t one magic bullet. It’s actually combining many tactical elements  in the billing and payment process, including an ability to present the EOB with the patient bill. Ultimately, by enabling consumers to quickly understand and pay their bill, you’re giving them more power over their financial responsibility—ultimately creating feelings of loyalty and trust.

“Slump months” are inevitable, and healthcare organizations sometimes find it hard to financially weather Q1. With your experience working with healthcare organizations, share some successes you’ve seen with implementing digital financial options to patients.

At PatientPay, we see across our clients that text-to-pay strategies greatly improve cash flow and patient engagement by capturing payments faster which is important during “slump months”. By eliminating traditional paper statements and associated delays, in many cases, our medical groups are seeing immediate returns on their investment.

For example, one of our clients, Central Nebraska Rehab—a 16+ location physical, occupational, and speech therapy group—began taking a proactive approach to patient payments by incorporating text-to-pay. Today, they collect over half of electronic payments within the first 14 days of sending a bill notification. It’s an approach that has also decreased inbound calls from patients asking about financial balances and returns more time to staff to focus on things like denials prevention and management. Today, over 80% of card payments processed at Central Nebraska are completed without involving office staff.

How important is it to meet patients’ needs and wants when it comes to payment options and processes? How does this impact the organization’s collections and bottom line?

It’s important to realize that a patient’s financial health is inherently tied to their overall mental health. This also influences behavior around healthcare access and payment. At PatientPay, we take a very data-driven approach to patient communication and the methods and mediums by which we do so. By leveraging behavioral science, we know that the best communication takes place digitally—specifically via text message. Across our clients, we’ve seen many instances where they start receiving payments literally minutes after initializing text-based bills. Some of these patients had never received anything besides a paper statement from a particular provider. I think this speaks volumes to how a patient-oriented solution drives better financial experiences that lead to more payments. The average specialty group takes 45 to 60 days to collect near 20% of patient financial responsibility, but in our experience, 43% of patients who click a payment link received via text go on to pay their bill.

For specialty practices like physical therapy, what are some ways to ensure positive financial engagement when there is a high recurrence of patient visits?

These groups have another layer of challenges due to the volume of claims they are processing on behalf of patients. If a single patient receives care multiple times a week, they generate a claim for each visit. These claims are likely at different phases in the cycle, which means the patient balance is fluctuating. This makes it difficult for patients to understand what they owe and stay on top of payments.

For physical therapy groups, it’s even more important to make it easy for patients to understand what they owe for the care they’ve received. If not, you run the risk that patients will delay payment, choose not to pay it, or get so frustrated with the overall financial experience they won’t return for future services. Mobile pay platforms can be leveraged to quickly break down which charges are for which visit.  PatientPay currently sees 71% of its payments coming from a mobile device.  By ensuring balances due start with the most recent date of service, patients gain a clearer view of which of their claims have been processed and how much they still owe. This decreases confusion while giving patients greater peace of mind that they are properly managing their financial responsibility.

What benefits do organizations get by moving to a mobile payment platform? What benefits do patients get by using a mobile payment platform like PatientPay?

As I’ve said, the best digital tools meet patients where they are, and patients are always with their smartphone. A mobile pay platform eliminates barriers to payment—like long wait times for paper statements—and delivers very clear instructions for how patients can fulfill their financial responsibility on their own terms. When patients feel in control, they are more likely to manage the cost of care in a timely manner. Mobile pay platforms like PatientPay also have a leg-up on other digital payment methods. The convenience of a digital experience is lost if a patient has to continually login to a patient portal and re-enter their payment information every time they make a payment.

On the provider side, a recent joint study with one of our revenue cycle management partners revealed that 46% of payments are processed in less than 10 days when bills are delivered via text communications which means there is not a need to send a paper statement. If you extend that out to 30 days, that number jumps to 78%. Some of our clients don’t send a paper statement until after the first 30 days based on these capture rates.  Overall collections showed an increase in total payments of over 50% when compared year over year. That significant improvement in cash flow plus a reduction in paper statement cost is huge for medical groups—and all it takes is the right mobile pay platform.

You mentioned that patients want more options. Can you explain the options that will create positive patient experiences while also meeting financial goals for healthcare organizations?

Self-service options for account management—like scheduling a single future payment to align with their payroll deposit or the ability to self-enroll in payment plans through text-to-pay—help patients feel more in control of how they approach their financial commitments.

Most of our PatientPay clients have incorporated self-service payment plans into their strategy, and it’s been transformational for patients and the provider’s bottom line. Patients receive text reminders to let them know a few days in advance of when monthly payments are processed—minimizing payment plan failures and boosting online payments. Before, patients often made single low payments every month or so. Not only were patients slower to pay down their balances, but this also increased the administrative burden and overall cost to the provider’s staff. With the new self-service method, patients are setting up larger payment amounts, and they have the ability to manage their balance on their own terms without the staff interaction.

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Cross-country Collaboration Vital to Shape the UK into a Life Science Superpower https://thejournalofmhealth.com/cross-country-collaboration-vital-to-shape-the-uk-into-a-life-science-superpower/ Wed, 14 Feb 2024 22:31:00 +0000 https://thejournalofmhealth.com/?p=12860 Paula Rogers-Brown, Head of Communities & Ecosystem Engagement, Connect: Health Tech, shares her perspective on the challenges facing the UK health tech community and how...

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Paula Rogers-Brown, Head of Communities & Ecosystem Engagement, Connect: Health Tech, shares her perspective on the challenges facing the UK health tech community and how with collaboration and a unified voice, we can overcome these to build the UK into a thriving health tech hub and life science superpower.

What are the major challenges facing health tech businesses in the UK?

The UK’s health tech ecosystem is rather fragmented, stemming from a positive trend for organic growth. As a consequence, this has fostered poor interconnectivity. It is well known that interdisciplinary collaboration is key for the success of most innovative industries, and this is just as true for health tech. To facilitate more collaboration, we need to overcome this fragmentation and build more connections. Locally, removing siloes will help complementary teams interact, but this should not be done at the expense of pan-regional collaboration as we need to harness the wealth of expertise available throughout the UK for long term growth.

At the interface of health, technology, engineering and AI, health tech faces its own language barriers: clinicians are unfamiliar with common tech terms and technology specialists are untrained in medical terminology. This challenge is not insurmountable, but it is easy to underestimate the time frames needed to overcome this and work well together on product development and commercialisation.

Another challenge is a lack of knowledge around entrepreneurship in the research community. There are incredible scientists and clinicians with potentially transformational ideas, but without a knowledge of routes to progress their innovation, and an understanding of aspects like IP, commercialisation, funding and regulation, their ideas may never reach the public. It is therefore vital that we share knowledge and resources about where these entrepreneurs can start, what do they need and where can they find more information?

To improve navigation across the ecosystem, Connect: Health Tech proactively aids these connections, collaborating with innovation hubs like Discovery Park, and forming a national network where ideas and information can be shared.

What do we need to do to support the UK health tech industry?

We need to build an industry with a porosity in knowledge exchange. Fellowships could be a good way to encourage this area – not just academic but industrial too – as they can be used to foster knowledge exchange between industries and different locations.

It’s also important that we invest in the infrastructure to develop both physical and digital communities that support these connections. Events and in-person connections form a cornerstone of all collaboration. Science parks like Discovery Park provide an ideal environment to bring together a diverse mix of stakeholders including academia, clinical innovators and industry for knowledge exchange and

interdisciplinary innovation. We’ve also learned over the past few years that online communities can provide significant additional benefits, allowing these collaborations to continue between different locations in between these events, enabling existing ideas to develop and new opportunities to be identified.

I would also draw attention to the visibility of role models within the health tech community. We have an incredibly diverse population with different healthcare experiences and health technology has the potential to make real changes for everyone, but if the diversity of the population is not reflected in those developing innovative research and technologies, then solutions will have a limited market. To build this diversity into research and leadership teams, we need to highlight role models that are already there – after all, you can’t be what you can’t see.

Investment and development have often been targeted towards certain areas of the UK. Are there risks in focusing development within specific regions?

Co-location is a really powerful tool when it comes to sharing ideas and building a rich talent pool, but this shouldn’t be done at the expense of collaboration elsewhere. The UK punches above its weight scientifically. We are a relatively small country geographically and with the right networks, both regionally and nationally, we could strengthen our impact and attractiveness.

Another important consideration is ensuring research and innovation development is inclusive. Different regions within the UK have different demographics and we need to understand and incorporate that into our recruitment strategies. There is no one route for developing a new innovative med tech device, for example, and the health tech ecosystem needs to embrace employees from all backgrounds. That way we can be sure we are not missing opportunities to harness and develop talent on our doorstep which can lead to rich innovations we can all benefit from.

Science and research parks have a really important role in doing this as they are directly embedded in their local communities and can therefore work closely with schools, colleges and universities to promote STEM, the opportunities available, and develop their own talent pipeline.

As an example, Discovery Park provides a thriving community to build connections and exchange knowledge, including a Skills Hub that brings together the expertise of Kent Universities, colleges and industry to help businesses collaborate to overcome skills shortages. Adding in an online collaboration hub to these can extend those opportunities across the four nations – and internationally.

The NHS is a unique resource for the UK, what are the opportunities that this can bring?

At Connect: Health Tech, we support clinician-led innovation. The UK’s clinician base is a unique resource that has a truly in-depth understanding of the healthcare needs of our population. Through our community and digital platform, we are proactively working with clinicians to develop a suite of resources that supports their innovation journey. Supporting innovation from this community to ensure we are at the forefront of producing solutions that meet actual needs is really important to us at Connect: Health Tech.

Working with local NHS teams can be a huge asset to technology developers to ensure their technology is solving a genuine need. It can also result in superior product development by incorporating relevant data sets and ensuring optimisations are made with input from clinicians and patients alike. Research campuses like Discovery Park leverage relationships with their local NHS Trusts to facilitate collaborations with industry to drive purposeful innovation.

What other opportunities do you see for the UK health tech industry in the next five years and how can we help to deliver these?

Pan-regional collaboration is a fantastic opportunity that we are seeing a real shift towards, and we need to continue to develop this to see more of this kind of collaboration at scale. We’ve already seen the formation of a cross-regional innovation cluster between Cambridge and Manchester which will facilitate the sharing of expertise between these two knowledge-rich communities. Building relationships with other knowledge exchange hubs like Discovery Park allows further development of pan-regional collaboration to unlock even more opportunities for growth.

I was delighted that the government recently accepted all the recommendations from the independent review of university spin-out companies, including providing greater understanding of entrepreneurial skills in the academic setting. There is huge potential still to be realised from our wealth of successful academic institutions and we need to develop this potential by providing support, advice and training for founders wishing to commercialise their discoveries. Initiatives like the Eagle Lab at Discovery Park can provide fantastic support for fledgling businesses through programmes, mentorship and investor networking.

What do we need to do to ensure these opportunities aren’t missed?

We need to invest! The opportunities are clear, but they require investment, and these investments require some risk-taking on experimental technologies. We also need to invest in developing the right infrastructure, taking our communities with us through enablers like Connect: Health Tech, and building strong foundations for growth, as creating a solid health tech ecosystem reduces the risk of missed opportunities.

About the author

Paula Rogers-Brown leads on the strategic development and management of Connect: Health Tech, an interdisciplinary community of practice for health tech professionals bringing together a diverse range of stakeholders to build and integrate a thriving business and enterprise community.

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Empowering Patients with Mobile Pay Opportunities https://thejournalofmhealth.com/empowering-patients-with-mobile-pay-opportunities/ Tue, 19 Dec 2023 06:00:00 +0000 https://thejournalofmhealth.com/?p=12719 AccessOne is a leading healthcare fintech company that is partnering with health systems to provide consumer centric mobile payment tools for the modern patient. We...

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AccessOne is a leading healthcare fintech company that is partnering with health systems to provide consumer centric mobile payment tools for the modern patient. We spoke to Joe Hall, VP of Business Development to find out how mobile pay opportunities can empower patients and help improve the revenue cycles of healthcare providers.

The percentage of bills owed by patients has risen exponentially. What challenges does this growing trend present?

The biggest challenge we’re seeing as healthcare expenses rise is that many consumers already lack the funds needed to pay medical bills that exceed a mere $250.

The recently passed No Surprises Act by Congress, which led the top three credit bureaus to agree to drop most medical debt from consumers’ credit reports, certainly helps consumers. But the reality is that many people who have high-deductible health plans can’t handle sudden, unexpected expenses. While they might know, intellectually, that their health plan’s deductible is $1,000 for an ER visit, it’s still not uncommon for a patient to experience sticker shock when they receive that $1,000 bill for an emergency operation.

Many of us can’t pay $1,000 without dipping into personal savings or using a personal credit card.

This creates a vicious cycle: If consumers are stressed or struggling to pay for urgent, critical care, they’re possibly more likely to put off preventive care such as screenings, or elective care like an operation, that is still essential to their health and wellbeing.

According to AccessOne’s most recent (2023) consumer survey, nearly one out of three 18- to 34-year-olds (31%) have gone as far as postponing needed care or procedures, and 40% of respondents ages 18-44 have delayed or opted not to fill a prescription to save money on healthcare expenses.

Unfortunately, we all know that when consumers drop preventive care and screenings, they’re more likely to need a higher level of care that’s more expensive down the line.

Paper statements are still a top way patients receive and pay their medical bills. What will it take to empower patients with mobile pay opportunities?

The reason paper statements are so popular is that many of us aren’t aware there is a better solution out there.

Healthcare organizations can do more to build awareness around mobile/digital pay opportunities. For example, they can market these services to patients when they visit — perhaps using incentives to drive enrollments. They can emphasize the simplicity of one-touch digital solutions, which enable patients to pay bills as easily as ordering household goods on Amazon.

Of course, this is contingent on organizations having a solution that is better than paper statements! An example of this would be a one-touch “text to pay” app that isn’t just a link to an online patient portal, which requires remembering a password and navigating through a myriad of menus.

Another thing healthcare organizations can do is combine digital payment solutions with other digital services on an app, such as scheduling apps.

It’s important to spend time thinking about what it would take to get patients to want to change their financial behaviors. Emphasizing convenience and speed is a good way to do this.

Research shows that consumers would pay bills faster when offered digital payment options. In your 16+ years of experience, can you share what you’ve seen in the market and/or with users of AccessOne?

It’s true that consumers pay bills much faster when offered digital payment options — especially millennial and Gen Z adults.

While 19% of all respondents to AccessOne’s most recent consumer survey said they prefer being contacted by secure text message when a healthcare balance is due, that percentage shot up when the individual was younger: Thirty percent of Gen Z respondents say they prefer being contacted by secure text message, as do 22% of millennials, for example. Only 9% of Gen Z respondents say they prefer paper statements, compared with 26% of Boomers.

The preference for digital over paper is only expected to grow, especially as technology evolves.

How important is it to create patient-centered, one-touch solutions that speak to consumer’s need for accessible, convenient options?

I believe there is a direct relationship between the evolution of one-touch solutions and consumer demand for better user experiences with digital payment. For example, in the 2010s, digital payments took the form of a patient sitting at their desktop and trying to remember their login and password credentials. The easier the payment experience gets, the more we’ll see Americans opting to pay healthcare bills or manage their accounts via their tablets or mobile phones.

True one-touch solutions are a key to getting consumers financially engaged, and the sooner we adopt these solutions on a broad scale, the better.

You mentioned digital communications. In what ways do digital communications about bill payments and reminders help the overall patient payment experience?

Reminders are a great thing — as long as they’re not dispatched too frequently, which can trigger alert fatigue. For instance, some organizations send a reminder text after seven days. Some send a reminder after three days. Often, these organizations wait a week to send a paper billing statement to give digital communications a chance to breathe. Leading organizations also look at the patient’s past payment history to determine how often to send a digital notification — and whether to send one at all. A patient who is not likely to pay, for example, might be a better candidate for a limited mailing of paper statements.

Alerting a patient that it’s time to make a payment and offering a link that a user can click on to make a one-touch payment can ease stress. The patient won’t worry about incurring penalties because their bill is buried in a stack of mail or in their email inbox’s spam folder.

What benefits are there for healthcare organizations when practices include mobile payment options?

The biggest benefits for healthcare organizations and revenue cycle teams are transparency and convenience, which lift administrative pressure off employees and make it easier to engage patients in their financial obligations for care. The right approach also will decrease phone calls to customer service, allowing team members to focus on more value-added work.

Patients who are blindsided by a $500 medical bill are more likely to feel some level of resentment about their overall healthcare experience. This includes their level of satisfaction with their actual care. On the other hand, those who know the cost of a procedure or treatment ahead of time (and can plan for it) tend to be the most satisfied.

When polled on their satisfaction with their healthcare providers’ payment options, 17% of survey respondents said they are dissatisfied with what they’re being offered — which shows there’s room for improvement. We believe that the move toward digital payments is the best and easiest way to strengthen the patient experience and ultimately financial engagement.

AccessOne, a leading healthcare fintech company, partners with health systems to provide consumer centric mobile pay tools for the modern patient. From pay-in-full to extended payment plans, the company’s mobile-native pathways make understanding and paying medical bills easy and affordable. Text-to-pay platform strips out the need to remember usernames, passwords or account numbers, creating a frictionless experience that drives more payments. Inclusive patient financing solution adds a Care Now, Pay Later component that accepts all patients, meaningfully lowering the financial barriers to receiving high-quality healthcare. AccessOne is reimagining payments for healthcare. 

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3PARL Consortium to Assure Global Life Sciences Industry of High Standard of GMP Supply Chain Audits https://thejournalofmhealth.com/3parl-consortium-to-assure-global-life-sciences-industry-of-high-standard-of-gmp-supply-chain-audits/ Tue, 05 Dec 2023 11:13:00 +0000 https://thejournalofmhealth.com/?p=12706 The new Third-Party Audit Report Library (3PARL®) consortium, founded by Rephine and Eurofins Healthcare, aims to set a benchmark for life sciences manufacturing supply chain...

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The new Third-Party Audit Report Library (3PARL®) consortium, founded by Rephine and Eurofins Healthcare, aims to set a benchmark for life sciences manufacturing supply chain Good Manufacturing Practice (GMP) audit services globally. In this interview, Adam Sherlock, CEO of Rephine, explains more about how the consortium will support high audit standards.

What was the thinking behind setting up the consortium?

The use of third-party auditors and the purchasing of library audit reports has become a standard business model for manufacturers and their customers to provide evidence of supply chain quality, assurance and regulatory compliance, to all stakeholders in the life sciences sector, specifically focussed on the GMP requirement.

However, as the niche of providers of this specialist service has rapidly expanded, and the range and type of provider has broadened, it has become obvious that not all auditors, audits and audit reports are equal. Coupled with commercial pressures, this range of provider type has driven inconsistency in behaviour within the auditing sector. This has introduced uncertainties around integrity and impartiality, which in turn adds risk to the supply chain through compromises in quality of the service being performed and the final reports which are delivered, upon which assurance and compliance are based.

To address this systemic risk, the leading, longest tenured, best reputed, competitive commercial service providers in this niche came together to create the 3PARL consortium, as a vehicle to define and adhere to a set of standard ethical behaviours, which provide our industry and all stakeholders with confidence in the performance of this scope of services and the quality of the resulting reports, upon which everyone relies.

What is the consortium’s roadmap?

The initial roadmap for the consortium is to expand its membership beyond the founding collaborators, to define a charter, to review and iteratively enhance the initial code of conduct, to meet regularly to chart the course of the consortium, and to engage manufacturers, trade associations and other key stakeholders as appropriate, to ensure our message is heard, understood and reflects the needs of the industry.

In the mid to long term, the aspiration of the consortium is to define professional standards for the performance of the scope of services covered by the group and to be able to certify and accredit members.

There is also a clear aspiration to lead the sector in terms of training, education and career development for professionals wishing to become auditors or those wanting to enhance their current credentials.

Rephine and Eurofins Healthcare are the founders of this consortium. How do you intend to bring other members on board?

We are already in advanced, direct discussions with a number of other important, well-known providers in this niche. In addition, we have made an open call to providers in the sector to apply to join the consortium.

What is the benefit of being a 3PARL audit partner and who will conduct the audits? Are they independent?

The benefit to a service provider of being a member of the 3PARL consortium is that the quality of the performance of their services will be seen to be of a consistently high quality, delivered ethically, with integrity and impartiality, fairly, according to a consistent and transparent code of conduct, to which all members have agreed to adhere and be bound.

Each organisation which becomes a member of the consortium retains its independence and continues to actively compete commercially with the other members of the consortium, but crucially, does so on the same level playing field.

For customers and manufacturers, by choosing to contract with a 3PARL consortium member, they are assured of the consistent performance of the service they need, enabling them to make their choice of whom to use based on the most important and relevant specific criteria for their requirements. There is no commercial relationship between any members of the consortium – it is not a commercial endeavour in any way.

Can you expand on the benchmark, and who will ratify it and conduct any audits?

The code of conduct is defined and monitored by the consortium members themselves. At this stage there is no external independent ratification or certification required. We expect and hope that in future, once the value of the work of the consortium has been demonstrated and is acknowledged by the industry, that some form of external ratification or certification may be possible.

All audits conducted by members of the consortium are performed by either their own internal staff or by independent auditors who have been qualified by the consortium member through a standard selection process, endorsed by the consortium.

What reception has the industry as a whole given the consortium?

The response to the announcement of the 3PARL consortium has been extremely positive across the whole life sciences product manufacturing supply chain. It is seen as a strong statement of intent on the part of the larger, professional service providers to create a standard operating model for the sector.

Adam Sherlock, a serial entrepreneur, executive business leader and experienced board member, is CEO of Rephine Ltd. He is passionate about building businesses and has a strong track record of delivering impressive growth across Life Sciences. Rephine provides bespoke technology and manufacturing supply chain compliance consultancy and third-party auditing.

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