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The time has finally come for hospitals to keep pace with other industries patient experience-wise, analyst firm says.

A global investigation has found that unsafe medical devices have caused 1.7 million injuries globally and almost 83,000 deaths in the last 12 years. According to The Implant Files, a year-long investigation of the manufacturers of devices by the International Consortium of Investigative Journalists (ICIJ), unsafe medical devices have been allowed into global markets as a result of poor regulatory systems, a lack of transparency and insufficiently strict rules on testing.   Some of these medical devices that have caused “adverse incidents” include pacemakers, contraceptives, artificial hips and breast implants grafted into patients’ bodies.  The investigation found some devices did not complete patient trials. The report stated that some pacemakers, for example, were implanted even though their manufacturers knew of problems; other devices were approved without proper regulatory procedures.  In the report, ICIJ referenced a case in the US, where 27-year-old Charlissa Dawn Boyce’s family filed a lawsuit after an an implantable defibrillator, which was later recalled by St. Jude Medical for battery problems, didn’t shock her heart back into beating and resulted in her death. It found that nearly 350,000 of the defibrillators were used on patients globally before the recall occurred in 2016. Another example of a faulty medical device is in India, where 44-year-old Vijay Vojhala suffers from difficulty walking, vision problems and irregular heart rhythms, which he claimed was a result of his Johnson & Johnson replacement hip. More than half a million patients globally got these replacement hips before they were taken off the market. Webinar: Optimizing Medical Device Safety: A Closed Loop Processy Findings "underline the need for drastic regulatory changes" Oxford University Clinical Epidemiologist Carl Heneghan told the Australian Financial Review it was unacceptable to keep maintaining this system. The findings have raised questions over how much scrutiny devices actually undergo in the global industry before being used on patients and if regulators pick up and act on findings fast. According to The Guardian, the Royal College of Surgeons President Professor Derek Alderson said the number of incidents involving flawed devices is enough to “underline the need for drastic regulatory changes”, in addition to the introduction of mandatory national registries for implantable devices. “In contrast to drugs, many surgical innovations are introduced without clinical trial data or centrally held evidence,” he said. “This is a risk to patient safety and public confidence.” According to the Australian Financial Review, US trade group for medical device manufacturers AdvaMed recommended that medical devices should be assessed differently to pharmaceuticals as implants are harder to randomise during clinical trials than drugs.  "To suggest that human trial mandates would end future harm misleads both the patient and the public into falsely thinking that all adverse events can be erased through such trials," AdvaMed Head of Technology and Regulatory Affairs Janet Trunzo said.   Trunzo also spoke against industry businesses that claimed to have problems reaching patients after recalls. "High-risk medical devices, especially life-sustaining implants, have specific tracking procedures in place to ensure companies can quickly notify patients and providers of any significant issues," Trunzo added. Responding to questions from the ICIJ, the US Food and Drug Administration (FDA) mentioned that patient remains a cornerstone of its regulatory commitment and that it is working towards the creation of a program that scans clinical information and other data to identify problems quickly. It also recently introduced a new goal to be "consistently first among the world's regulatory agencies to identify and act upon safety signals related to medical devices". The ICIJ identified The Implant Files as the “first-ever global examination of the medical device industry and its overseers.” To run the investigation, ICIJ journalists, along with 250 reporters and data specialists across 58 media organisations in 36 countries teamed up to assess device incident reports, analyse health records, and run patient interviews.  Originally published on Healthcare IT News Australia.

Since opening its doors to the first patients in September this year, the New Children’s Hospital in Helsinki, Finland is using a unique combination of art and play, recognised as key elements for a “healing environment", and the latest technologies available to support the children that it provides services for and their parents. With a total budget of €183m, €40m from the state of Finland, another €40m from the hospital district of Helsinki and Uusimaa, and €38m raised by a Foundation created for the new facility, the hospital is cultivating a culture of innovation – and the HIMSS Insights team went to find out how.  In an interview published in the first issue of the new global Insights eBook series, Professor Pekka Lahdenne, Head of Digital and Innovative Services at the hospital, who specialises in Paediatrics, explained that an “efficient ICT infrastructure was a priority for future development of a modern hospital”. Webinar: Patient Engagement: Transforming the Patient Experience with Innovative Digital Services “A lot of effort was invested in ensuring that the ICT platform would provide capabilities for future developments,” Professor Lahdenne said.  The full interview can be read here. A site visit at the hospital will be organised during the HIMSS & Health 2.0 European conference taking place in Helsinki, Finland, on 11-13 June. Healthcare IT News is a HIMSS Media publication.

Some doctors at Massachusetts General Physicians Organization have saved more than two hours per clinical session with virtual scribe technology.

As the potential of edge computing becomes more widely recognized, healthcare organizations will be expected  to take advantage of it, ready or not.

Here’s a look at what hospitals need to move forward, and the top priorities and biggest obstacles they face today.

NHSmail national outage caused by “software issue” The national NHS email service managed by Accenture suffered a "severity 1" outage midday on 1 December, caused by a “software issue in the supplier’s internal infrastructure”, which meant that NHS staff were unable to access their accounts. All users had their access restored by 8pm, and accounts locked out after multiple login attempts were unlocked by 10.30pm the same day. The NHSmail service is approved by the Department of Health and Social Care for sharing patient-identifiable and sensitive information. “We apologise for the inconvenience caused and worked to resolve the issue as soon as possible, which was caused by an internal issue with the supplier’s software. Thank you to the teams today [1 December] who have worked hard to resolve this,” NHS Digital said in a statement. In November 2016, a software configuration error saw an NHSmail local administrator accidentally email all NHS staff in England after creating a new distribution list intended to include only employees within one Commissioning Support Unit. Around 500 million emails that needed to be processed were sent in only 75 minutes, as staff used the “reply to all” function asking to be removed from the list. The incident resulted in “significant service delays for the majority of the day” at the time, according to a report presented to the NHS Digital board. Webinar: What Innovation Means to Healthcare and Why it Matters Today NHS staff investigated for illegally accessing medical records of Sir Alex Ferguson The Sunday Times has reported that two doctors and a senior hospital consultant were being investigated and “at least” two nurses questioned for accessing former Manchester United manager Sir Alex Ferguson’s medical records. Ferguson was admitted to the Salford Royal Hospital in May this year after suffering a brain haemorrhage. In a statement provided to the paper, Dr Chris Brookes, Northern Care Alliance NHS Group Chief Medical Officer, said an investigation was underway “to determine if the individuals have accessed a patient’s record electronically without a clinical requirement or authorisation”. Last week, the Information Commissioner’s Office, the UK’s data protection watchdog, fined a former trainee secretary at a GP surgery in Norfolk for unlawfully accessing 231 patient records without a valid reason to do so. “People whose job allows them access to confidential and often sensitive information have been placed in a position of trust, and with that trust comes added responsibility,” said Mike Shaw, the ICO’s Criminal Investigation Group Manager. “Data protection law exists for a reason and curiosity or boredom is no excuse for failing to respect people’s legal right to privacy. Just because you can do something, that doesn’t mean you should.” New pilot moves the NHS further away from paper prescriptions Eight GP practices in England are piloting a new functionality that could, once fully rolled out, see more than 95 per cent of prescriptions be processed through the Electronic Prescription Service (EPS). The digital system currently allows GP surgeries to send prescriptions to a dispenser (such as a pharmacy) nominated by the patient. But if the new pilot, which will be extended to other practices in 2019, proves successful, the improvement will allow prescriptions for all patients to be sent using the EPS, according to NHS Digital. “In an NHS where thousands of GP surgeries already enjoy the benefits of electronic prescriptions, it can’t be right that there are occasions when archaic paper prescriptions still have to be used,” Health and Social Care Secretary Matt Hancock said earlier this year. Bupa extends partnership with Babylon Bupa’s existing and new SME customers in the UK with two or more employees will be given access to the Babylon app starting from January next year, the company said last week, after announcing that it would roll out the service to its corporate customers back in June. “Our business customers often say it’s hard to find the time to look after their health, this is even more apparent for employees or owners of a small company,” said Mark Allan, Bupa UK Insurance Commercial Director. “We’re always looking for ways to make access to quality healthcare easier and more convenient – extending our work with Babylon is a key part of this." Twitter: @1Leontina Contact the author: lpostelnicu@himss.org

HIMSS Analytics found health facilities more prepared for the distributed ledger tech than many might think, but that doesn’t mean they’re making forward progress just yet.

The UK's Academy of Medical Sciences has published a report outlining a set of principles to guide the development, evaluation and use of data-driven technologies in healthcare, through a project partly funded by a grant from the Department of Business, Energy and Industrial Strategy. The new framework is based on a series of workshops involving patients, healthcare professionals, the broader public, and discussions with key stakeholder groups, including NHS regulators and digital health companies. It argues that data-driven technologies should be designed and used for health and care to: Support clearly defined purposes upholding the social values of the NHS and benefiting the system, individuals or society Respect and protect the privacy, rights and choices of patients and the public Include them as active and meaningful partners Maintain trustworthiness in the responsible and effective stewardship of patient data Incorporate evaluation and regulation mechanisms to build understanding, confidence and trust in these technologies, and guide their deployment in the NHS. Webinar: AI: Evaluating Opportunities for Healthcare Providers To make this a reality, however, experts warn that improvements to the digital capabilities of the NHS, an integrated data infrastructure and a radical cultural shift are required, while further analysis is needed to understand their use in social care, given that the "experience of accessing and using social care data in the UK is very limited". “The Academy report builds on what the patients and the public have told us matters most to them," said Professor Carol Dezateux, associate director of Health Data Research UK (HDR UK), the national institute for data science in health, and one of the experts consulted for the project. "By putting the public’s expectations at the centre of the use of data-driven technologies, the NHS, scientists, researchers and developers will be able to work together to deliver maximum health benefits for all, while keeping public trust," Professor Dezateux added. A draft of the academy's report was shared with the Department of Health and Social Care during the preparation of the initial code of conduct for AI and other data-driven healthcare technologies released in September this year. Meanwhile, NHS Digital announced today that it was joining a new initiative called the UK Health Data Research Alliance, along with HDR UK, aiming to "mobilise the UK's health data for science and innovation". “This new alliance brings together the unique data assets across the NHS, and allows access to them by the research community in a safe, secure and ethical framework. From this will flow new treatments and insights which will transform outcomes for patients,” said health minister Lord O’Shaughnessy. Twitter: @1Leontina Contact the author: lpostelnicu@himss.org