How safe is that app? App released today is the first to be registered as a Class I medical device by the MHRA

UK charity draws attention to the regulation of health apps and publishes guidance document to help health professionals, organisations, patients and industry

10 January 2012, London – A new app, Mersey Burns, has been released on to the market that represents a first in the UK – it has been registered with the MHRA as a Class I medical device as per the EU Medical Device Directive.   To coincide with this, d4 have simultaneously published a new guidance document to help draw further attention to the issue of health app regulation and provide practical guidance to both users and manufacturers of apps for the healthcare market.

Health professionals make considerable use of mobile phones during their working day, as do their patients.  As the popularity of running software applications on mobile devices continues to increase, we anticipate that the use of apps to aid medical diagnosis and treatment will gain in popularity with a corresponding increase in risk to the general public.  Specific regulations that accompany this nascent technology are in their infancy, but should not be ignored.

For all stakeholders concerned, it is in our collective interest to support responsible use of this new technology. It will take one high profile failing to cause a loss of trust that can take months, if not years, to rebuild.  In their guidance document, Regulation of health apps: a practical guide, d4 make the following recommendations:

1. Health professionals should carefully consider the risks when using apps to determine a patient’s care.
2. Developers should test their apps thoroughly and maintain adequate technical documentation to evidence this.
3. Publishers should ensure compliance with the necessary regulations before releasing apps on to the market.
4. Organisations should investigate ways to manage the use of apps by their employees, and put in place mechanisms to identify those apps that are deemed fit for professional use.
5. Patients should examine carefully the source of the apps they use to manage their health.  Within Europe, health apps that influence a patient’s treatment should carry the CE mark to demonstrate their conformity with the appropriate regulation.

“mHealth is a new industry and the regulatory environment is evolving,” said James Sherwin-Smith, CEO of d4. ”Regulators are necessary to safeguard the public and uphold confidence in markets that would otherwise be open to potential abuse. But regulations also need to support, and not stifle, innovation. The regulatory issues that surround health apps are complex and open to interpretation. We hope that this guide provides a useful steer for individuals and organisations alike.”

Solutions’ Ease of Use – Key to Adoptability and Patient Adherence

Scottsdale, AZ- Jan 9, 2012- MedApps, Inc., a leading mHealth (mobile telehealth) innovator is pleased to announce its alliance with MedMinder to bring connected, remote medication management to MedApps’ product and service offerings of flexible ScalableCare services.

Both companies have led the way in their respective areas of expertise within the telehealth market with affordable, easy to use, patient-centered remote monitoring solutions.

“Our partnering with MedMinder is very synergistic and our products compliment each other extremely well”, says Kent Dicks, Founder and CEO of MedApps. “The challenge with any prescribed therapy for patient care is compliance – whether that’s a patient taking their blood pressure or glucose readings on a daily basis, or taking their medication when they’re supposed to – and if it doesn’t get done, the caregivers’ efforts to manage patient conditions are ineffective.”

Dicks continues, “Our clients’ satisfaction has validated the fact that we’ve gone a long way in helping doctors and nurses gather the accurate and timely biometric data they need to more effectively mange patient health – and we think that MedMinder provides an equally valuable solution for the medication management side of things.”

Like MedApps, MedMinder provides products designed to keep patients connected to their care providers with a focus on ease of use to ensure a high degree of adoptability from the patient. MedMinder offers a unique solution to medication compliance through its “smart cellular pillbox”: Maya. On the surface, Maya appears to be an ordinary daily pill organizer, but it’s fully loaded with innovative features that effectively, yet simply enable medication management.

MedMinder pill dispenser can track patients’ dosage activity and deliver optional medication reminders or alerts to the user if medication is not taken within an assigned timeframe or if an incorrect medication compartment is inadvertently accessed. Additional options allow the patient’s family and care providers to be contacted if necessary to offer a more cohesive support system. MedMinder keeps records of patient medication activities and can provide access to reports for the user, their family and their caregivers via the Internet, email and text notification.

Combining MedMinders’ capabilities with MedApps’ supply of consistent, near-real time biometric data will deliver the most robust coordinated solution for medication management on the market.  Clinicians will have the ability to ascertain the effects of a given medication for an individual patient more rapidly – making adjustments and / or intervening when necessary.

“We are very excited about partnering with MedApps and integrating into their remote health monitoring platform – they are a true innovator in the field, said MedMinder Founder and CEO Eran Shavelsky.  “The companies’ philosophies of providing simple to use, transparent technology is a perfect fit. Our solutions’ ability to cost-effectively improve medication adherence and deliver a consistent supply of clinical and behavioral data will be unparalleled in medication management.”

This latest product offering is another illustration of the dynamic and scalable integration that is made possible by the MedApps CloudCare™ platform. MedApps has built a unique infrastructure for health information delivery that allows a variety of OEM devices to be integrated into a remote monitoring program very quickly with a minimum of coordination time.  CloudCare delivers the first true “Plug & Play” platform in the telehealth field.

About MedMinder

About MedApps

MedApps provides innovative technology solutions for the collection, transmission and remote management of patient health data. MedApps utilizes wireless and machine-to-machine technologies, hardware, software, and cloud computing to efficiently connect patients with their care providers and electronic health records. MedApps is an acknowledged innovator in the field of remote health monitoring, most recently recognized with a 2011 Edison Award in the product category of Health, Wellness & Safety. MedApps is a member of Continua, an industry consortium setting Medical Device Interoperability Standards worldwide. For more information, please visit www.medapps.com.

Telehealth Whole System Demonstrator (WSD) report – implications for the future of healthcare

Ivan McConnell gives his view on the implications of the Telehealth Whole Systems Demonstrator report for the future of healthcare.

Telehealth Whole System Demonstrator (WSD) report – implications for the future of healthcare

George MacGinnis gives his view on the implications of the Telehealth Whole Systems Demonstrator report for the future of healthcare

Published on Thursday 13 October 2011 00:01

A £5 MILLION telehealth system with the potential to save around £1,000 per patient per year has been largely ignored by NHS boards, the public spending watchdog has warned.

Telehealth is designed to provide remote electronic healthcare, particularly for hard-to-reach areas. But Audit Scotland’s review found that the system is generally not considered an option when NHS boards are planning or redesigning services.

An estimated £4.7m has been allocated to telehealth initiatives since 2006. Economic modelling work suggests the home monitoring of patients with chronic obstructive pulmonary disease could save NHS boards around £1,000 a year for each patient.

However, Audit Scotland found limited coverage in local delivery plans and only half refer to telehealth specifically.

Over a third of the medical directors interviewed did not know if the Scottish Centre for Telehealth (SCT), established in 2006 to support NHS boards to develop telehealth, was performing its core functions well.

Half of medical directors felt that the integration of SCT and NHS24 had no impact on the delivery of telehealth within the board.

Auditor General for Scotland, Robert Black said: “The NHS in Scotland is facing serious pressures from the ageing population and increasing numbers of people with long-term health conditions such as diabetes and respiratory illnesses.

“Telehealth could help to provide a range of services efficiently and effectively.”

Health secretary Nicola Sturgeon said: “Telehealth has a pivotal role to play in delivering efficient and effective care to people of all ages across our country.”

The Royal College of Nursing Scotland backed the auditor’s call. Director Theresa Fyffe said: “Investment has been inconsistent and a survey of our members last year, found that less than 20 per cent use telehealth.”

Read the article on Scotsman.com

This is to let you know all the presentations from our September Health Informatics Scotland conference in Edinburgh are now available to download.

Both slides (pdf) and audio files (mp3) are available so you can both watch and listen to presentations in the different streams perhaps from those you missed.

All details are available on our website Click Here

follow the links to the programme, the abstracts from speakers, the two pages of programme streams with links to the slides and audio files available to download

Please circulate to those that missed the event.  BCS Health Scotland provide this as a service to our professional community.

Paul Woolman

Chair Health Informatics Scotland (a not-for-profit conference) www.hiscotland.info

Note: Health Informatics Scotland 2012 is on 20-21 September 2012 in Glasgow

Written by IHT Staff writer.

According to market research firm Ovum, healthcare ICT spend will hit the £3 Billion mark by 2016, a growth of over 12% from figures in 2010. Aging population, increased healthcare requirements and the ongoing drive to slash costs in NHS operating costs are the key driving factors in this forecast. “The UK will experience the strongest growth over the forecast period of any market we looked at,” Cornelia Wels-Maug, Ovum’s healthcare technology analyst, said. “A key driver for the investment is the urgent need to do more with less, owing to the ever-increasing number of patients with chronic illnesses as the population lives longer.

The cost of delivering a healthcare service that doesn’t compromise on quality is spiraling out of control. Investments in IT are part of the solution,” she added. Ovum forecasts telehealth and healthcare information exchanges will be areas in the UK healthcare technology and IT industry that will see growth although electronic healthcare records and digital imaging technologies will continue as the main area for healthcare ICT investment in the UK.

Healthcare Informatics Spend in the UK to hit £3 Billion by 2016