Health Technology Assessment
Methods for estimation of the NICE cost-effectiveness threshold – Centre for Health Economics, University of York – 19 February 2015
“Cost-effectiveness analysis involves the comparison of the incremental cost-effectiveness ratio of a new technology, which is more costly than existing alternatives, with the cost-effectiveness threshold. This indicates whether or not the health expected to be gained from its use exceeds the health expected to be lost elsewhere as other health-care activities are displaced.”Read Full Post | Make a Comment ( Comments Off on Methods for estimation of the NICE cost-effectiveness threshold – Centre for Health Economics, University of York – 19 February 2015 )
Biomedical engineering: advancing UK healthcare – Institution of Mechanical Engineers – 25 July 2014
The Institution of Mechanical Engineers’ new report Biomedical engineering: advancing UK healthcare is calling for urgent action to prioritise the role of engineers in the NHS, and introduce a Chief Biomedical Engineer in every NHS acute trust.
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Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices – Draft Guidance for Industry and Food and Drug Administration Staff – FDA – 20 June 2014
“Thanks to advances in digital health, doctors and their patients are more frequently using computer systems to collect medical data that can provide useful information on a patient’s health.
Some of these systems, referred to as “medical device data systems,” are off-the-shelf or custom hardware or software products that transfer, store, convert format, and display medical device data without modifying it, and without controlling or altering the functions or parameters of any connected medical devices.
Medical device data systems can collect and store data from a variety of other medical devices, including glucose meters, blood pressure cuffs, and weight scales. This data can be used at home to track certain information or it can be stored for a doctor to review at a later time.
Medical device data systems can be used in hospitals to collect information and data from other medical devices including bedside monitors and infusion pumps. This information can then be stored in a patient’s electronic health record for a more complete review of a patient’s total health.
In 2011, FDA issued a regulation down-classifying medical device data systems. Since that time, FDA has gained additional experience with these types of technologies, and has determined that these devices pose a low risk to the public.
Today, given the low level of patient risk, we are proposing a compliance policy under which medical device data systems should see their burdens reduced.
Why would we do that?”
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Who Cares? The Role that Technology and Entrepreneurs Can Play in Improving Informal Care in the UK – Nesta [UK] – 1 May 2014
“This report examines the need to increase the supply and improve efficiency of informal care for older people, with a focus on the role that entrepreneurs and technology can play.”Read Full Post | Make a Comment ( Comments Off on Who Cares? The Role that Technology and Entrepreneurs Can Play in Improving Informal Care in the UK – Nesta [UK] – 1 May 2014 )
Redirecting innovation in US health care: options to decrease spending and increase value – RAND Health – 2014
“A leading cause of high and growing spending is new medical technologies. Previous studies aimed at reining in spending considered changing the ways in which existing technologies are used. Our work for this project focused on identifying promising policy options to change which medical technologies are created in the first place, with
these two related policy goals:
1. Reduce total health care spending with the smallest possible loss of health benefits.
2. Ensure that new medical products that increase spending are accompanied by health benefits that are worth the spending increases.
These goals reflect our definition of the “value” of a medical technology, which compares the increase in population health from using it to the extra spending attributable to its use. A medical product can have large health benefits for some patients and little or no benefit for others. Thus, a key issue for increasing value is improving the alignment between products and patients who will benefit from them.We define medical technology broadly to include all applications of knowledge to practical medical problems. However, in this study we focused more narrowly on medical products, specifically drugs, devices, and health information technology (HIT).”Read Full Post | Make a Comment ( Comments Off on Redirecting innovation in US health care: options to decrease spending and increase value – RAND Health – 2014 )
Patient safety alert to improve reporting and learning of medication and medical devices incidents – NHS England – 20 March 2014
“NHS England and the Medicines and Healthcare products Regulatory Agency (MHRA) have today jointly issued two patient safety alerts to help healthcare providers increase incident reporting for medication errors and medical devices. The alerts instruct providers to take specific steps that will improve data report quality; and will see the establishment of national networks to maximise learning and provide guidance on minimising harm relating to these two incident types.
The patient safety alerts call on large healthcare provider organisations across a range of healthcare sectors, along with healthcare commissioners, to identify named leaders in both medication and medical device safety roles. These leaders will be supported by two new national networks for medication and medical device safety. The networks will improve communication and feedback on reported safety issues, and enable safer practice to be discussed and shared through webinars, online forums, conferences and workshops.
Smaller healthcare provider organisations should continue to report medication and device incidents, take action to improve medication and device safety locally and work with local safety champions.
This joint work responds to a number of strategic drivers including recommendations by Sir Robert Francis QC and Professor Don Berwick on patient safety and a review by Earl Howe into MHRA’s handling of the PIP breast implant fraud. All recommended taking steps to maximise the quality and quantity of adverse incident reports from healthcare organisations.”
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FDA Finalizes Electronic Medical Device Reporting Rule – 14 February 2014
“A final rule promulgated by the US Food and Drug Administration (FDA) will require medical device manufacturers and importers to submit adverse event reports to the agency through a specific electronic format.
While FDA has long required manufacturers to report adverse events to it under 21 CFR 803, the medical device reporting (MDR) regulation, those reports have been submitted in paper form through Form FDA-3500A.
But as with many forms submitted to FDA, the agency is moving toward an electronic submission standard, arguing that digital submission is faster, cheaper, more accurate and allows for better analysis and reporting.”
… continues on the site
“Action: Final rule.
Summary: The Food and Drug Administration (FDA) is revising its postmarket medical device reporting regulation and making technical corrections. This final rule requires device manufacturers and importers to submit mandatory reports of individual medical device adverse events, also known as medical device reports
(MDRs), to the Agency in an electronic format that FDA can process, review, and archive. Mandatory electronic reporting will improve the Agency’s process for collecting and analyzing postmarket medical device adverse event information. Electronic reporting is also available to user facilities, but this rule permits user facilities to continue to submit written reports to FDA. This final rule also identifies changes to the content of required MDRs to reflect reprocessor information
collected on the Form FDA 3500A as required by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).
DATES: This final rule is effective August 14, 2015”
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“A toolkit to provide guidance on making donations of medical equipment to low-income countries
THET has today released new guidance for those wishing to donate medical equipment to hospitals and health clinics in the developing world.
Hospitals in many low-income countries rely significantly on donations of medical equipment. These donations are made with the best of intentions, however, the outcomes are not always positive. The World Health Organization estimates that up to 80% of the medical equipment in some sub-Saharan African countries is donated equipment. However, the majority is out of use due to the significant challenges faced by low-resourced health systems including; a lack of trained health workers and technical staff to use, maintain and manage the equipment, the absence of a strong supply chain for consumables and spare parts and an unreliable infrastructure to operate the equipment which is often without a good power supply, temperature control, water and medical gas.
The toolkit includes good practice guidance for each of the seven stages of the donation process, from initial discussions between donor and recipient about what is required to after donated equipment arrives, is installed and ready for use. We have also produced a series of videos highlighting the critical issue of medical equipment donations, as well as what THET is doing to support partnerships to improve the maintenance and management of equipment overseas. YouTube presentation – Watch it here.
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Capturing Value from Health Technologies in Lean Times – C.D. Howe Institute – 18 December 2013
“In budget-constrained times, adopting new drugs or medical technology is a high-stakes challenge that requires a comprehensive, balanced approach, according to a report released today by the C.D. Howe Institute. In “Capturing Value from Health Technologies in Lean Times,” authors Ake Blomqvist, Colin Busby and Don Husereau argue healthcare policymakers should make greater use of Health Technology Assessment (HTA), a policy tool that can help them balance demand and supply pressures for new technologies within a health-system budget.”Read Full Post | Make a Comment ( Comments Off on Capturing Value from Health Technologies in Lean Times – C.D. Howe Institute – 18 December 2013 )
Realizing the Promise of Healthcare Innovation in Ontario – Increasing Value for the Patient, Health System and Economy – Ontario Bioscience Innovation Organization – December 2013Read Full Post | Make a Comment ( Comments Off on Realizing the Promise of Healthcare Innovation in Ontario – Increasing Value for the Patient, Health System and Economy – Ontario Bioscience Innovation Organization – December 2013 )
Toward New Models for Innovative Governance of Biomedecine and Health Technologies – OECD – 5 December 2013
“This report examines examples of new and emerging governance models that aim to support the responsible development of diagnostics and treatments based on the latest advances in biomedicine. In particular, it presents programmes and initiatives that aim to manage uncertainty in the development and approval of new medical products and thereby to improve the understanding of the risk/benefit balance. It also identifies some of the main challenges for policy makers, regulators and other communities involved in the translation of biomedical innovation and health technologies from the laboratory bench to point of care.”
OECD (2013), “Toward New Models for Innovative Governance of Biomedecine and Health Technologies”, OECD Science, Technology and Industry Policy Papers,
No. 11, OECD Publishing. http://dx.doi.org/10.1787/5k3v0hljnnlr-en
The technology horizon: Preliminary review on technologies impacting the future health and social care workforce – Centre for Workforce Intelligence – 10 October 2013
“The Centre for Workforce Intelligence’s Horizon Scanning team has today published a paper designed to stimulate thinking around the impact of future technologies on the health and social care workforce.
The technology horizon: Preliminary review on technologies impacting the future health and social care workforce has been compiled from a literature scan across 28 selected initiatives or agencies from the International Network of Agencies for Health Technology Assessment and aims to provide a starting point to consider factors that may influence the requirements, numbers and proportions of the future workforce.
Developed with a team from the University of Manchester, it considers new and emerging technologies that are likely to impact the health and social care workforce which have been pooled into five emerging themes.
therapeutic technology – technologies used in the treatment of disease and injury, including pharmacological, surgical and psychological therapies
diagnostic technology – technologies for identifying diseases and other conditions
enabling technology – technologies that mitigate the impact of disease or disability
preventive technology – technologies that reduce the risk or severity of illness and injury
organisational technology – technologies supporting alternative health and social care delivery configurations and organisational design.
The purpose of the research is not to predict technological developments, but to identify possible areas of change, that may influence the requirements, numbers and proportions of the future workforce, and could stimulate changes in education and training, multidisciplinary working or priorities and practices.
Further research will include greater analysis of the trends and drivers identified in this report, and the CfWI will work with expert stakeholders to examine the workforce implications in more detail.”Read Full Post | Make a Comment ( Comments Off on The technology horizon: Preliminary review on technologies impacting the future health and social care workforce – Centre for Workforce Intelligence – 10 October 2013 )
U.S. FDA issues final rule on medical device identifier codes – Reuters – 20 September 2013
“The U.S. Food and Drug Administration issued a long-awaited rule on Friday requiring companies to include codes on medical devices that will allow regulators to track the products, monitor them for safety and expedite recalls.
The codes, known as unique device identifiers, or UDIs, will be entered into a database that the agency will maintain as a publicly searchable reference catalogue.
… continues on the site
(Reporting by Toni Clarke in Washington; Editing by John Wallace, David Gregorio and Sofina Mirza-Reid)”Read Full Post | Make a Comment ( Comments Off on U.S. FDA issues final rule on medical device identifier codes – Reuters – 20 September 2013 )
Regulation of medical software and mobile medical ‘apps’ – TGA – 13 September 2013
“Software is becoming increasingly important in medical devices; however, its rapid evolution, particularly in relation to mobile technology, presents new and complex challenges for the TGA and regulatory agencies internationally.
The following is intended to provide guidance on the regulatory arrangements pertaining to medical software and mobile medical apps by addressing some questions frequently put to the Therapeutic Goods Administration (TGA).
Are medical software products considered to be medical devices?
A software product is considered a medical device if it fits the definition in section 41BD of the Therapeutic Goods Act 1989.”
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Potential for Change: Transforming public awareness and demand for health and care technology – Carers UK – September 2013
“Carers UK, supported by Tunstall Healthcare (UK), commissioned a national opinion poll exploring attitudes towards health and care technologies, including telecare. The research highlighted a lack of public awareness of health and care technology, even amongst families using technology in most other aspects of their lives.”Read Full Post | Make a Comment ( Comments Off on Potential for Change: Transforming public awareness and demand for health and care technology – Carers UK – September 2013 )
Public involvement in decision making relating to potential: Technologies scoping report 16 – Healthcare Improvement Scotland – 17 July 2013
“What approaches have been taken and efforts made to ensure public involvement in decision making relating to potential disinvestment in healthcare interventions and technologies?
In response to an enquiry from the Scottish Health Council, Healthcare Improvement Scotland
The following question was scoped:
1. What approaches have been taken and efforts made to ensure public involvement in decision making relating to potential disinvestment in healthcare interventions and technologies?”
“Encouraging improvement through changing the relationships between healthcare service users and providers is a key area of work for the Health Foundation.
This report aims to contribute to the understanding of how changing relationships impacts on the quality of care. It does this by reviewing the conceptual and theoretical literature on relationships between service users and providers and then exploring the extent to which a chosen set of interventions correlate with the conceptual evidence, and their likely impacts on the quality of care.”
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“Today, in response to requirements in legislation that passed Congress with broad bipartisan support, the U.S. Food and Drug Administration proposed that most medical devices distributed in the United States carry a unique device identifier, or UDI.
A UDI system has the potential to improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems more quickly, better target recalls, and improve patient safety. The FDA has worked closely with industry, the clinical community and patient and consumer groups and conducted four pilot studies in the development of this proposed rule. The FDA is seeking comment on the proposal for 120 days.”
For more information:Read Full Post | Make a Comment ( Comments Off on FDA proposes unique device identification system for medical devices – 3 July 2012 )
FCC [Federal Communications Commission – US] to allocate spectrum for wireless medical monitoring – CNN Health – 17 May 2012
“The Federal Communications Commission says it plans to allocate spectrum bandwidth for use of body sensors that would monitor a patient’s vital signs wirelessly.
The spectrum will work specifically with MBAN (medical body area network) sensor devices. Similar in size and shape to a Band-Aid, the sensors would be disposable and include a low-power radio transmitter, according to an FCC official.
The primary function is to monitor a patient’s temperature, pulse, blood glucose level, blood pressure and respiratory health wirelessly.
“The benefits are clear: increased mobility, better care and lower costs,” FCC Chairman Julius Genachowski tells CNN.
Here’s how it works: Using the newly allocated spectrum bandwidth, the sensors on a patient’s body would wirelessly form a network, aggregate the results and transmit that data to centralized computer systems.
The idea is to provide real-time results for health care staff and more comfort for patients because they won’t be attached to machines by wires.”
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“The Global Harmonization Task Force has come out with a new document that, it hopes, will help standardize the way the world’s top healthcare regulation authorities, including the FDA, handle nonconformities during audits of medical device manufacturers’ quality management systems (QMS).
The manuscript, which is open for comment until June 22, introduces its non-binding guidance by explaining that, currently, regulatory bodies vary from one to the next in the weight they assign the significance of QMS nonconformities.
“All parties will benefit through the use of a standardized and transparent grading system of QMS nonconformities to communicate the findings of a regulatory audit, building the confidence necessary for the potential mutual acceptance of the results of a regulatory audit,” the proposed document reads.
The task force’s new grading system would offer a risk-based approach that would not only streamline regulators’ work in this area but also facilitate “global information exchange” among and between the task force’s member countries.
The manuscript lays out tentative guidance on grading and writing up the nonconformities, along with “escalation rules” to address higher-risk issues that have the potential to affect product safety and performance.”
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Health Effects from Radio Frequency Electromagnetic Fields – Health Protection Agency – 26 April 2012
ISBN: ISBN 978-0-85951-714-0
A report by the Health Protection Agency’s independent Advisory Group on Non-ionising Radiation (AGNIR) has concluded that there is still no convincing evidence that mobile phone technologies cause adverse effects on human health.
The report updates AGNIR’s previous review in 2003, considers the scientific evidence on exposure to radiofrequency (RF) electromagnetic fields, which are produced by mobile phone technologies and other wireless devices, such as Wi-Fi, as well as television and radio transmitters.”
26 April 2012
“A new report by the Health Protection Agency’s independent Advisory Group on Non-ionising Radiation (AGNIR) has concluded that there is still no convincing evidence that mobile phone technologies cause adverse effects on human health.”
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Coverage with evidence development, only in research, risk sharing or patient access scheme? A framework for coverage decisions – University of York, Centre for Health Economics – 10 April 2012
This research paper has been published simultaneously with a shortened version of the paper in Value in Health
Until recently, purchasers’ options regarding whether to pay for the use of technologies have been binary in nature: a treatment is covered or not covered. However, policies have emerged which expand the options – for example, linking coverage to evidence development, an option increasingly used for new treatments with limited/uncertain evidence. There has been little effort to reconcile the features of technologies with the available options in a way that reflects purchasers’ ranges of authority.
We developed a framework within which different options can be evaluated. We distinguished two sources of value in terms of health: the value of the technology per se; and the value of reducing decision uncertainty. The costs of reversing decisions are also considered.
Purchasers should weigh the expected benefits of coverage against the possibility the decision may need to be reversed and the possibility adoption will hinder/prevent evidence generation. Based on the purchaser’s range of authority and the features of the technology different decisions may be appropriate. The framework clarifies the assessments needed to establish the appropriateness of
different decisions. A taxonomy of coverage decisions consistent with the framework is suggested.
A range of coverage options permit paying for use of promising medical technologies despite their limited/uncertain evidence bases. It is important that the option chosen be based upon not only the expected value of a technology but also the value of further research, the anticipated effect of coverage on further research, and the costs associated with reversing the decision.”
Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad – Institute of Medicine – 4 April 2012
“Whether it’s suspect scallions from Mexico or contaminated ingredients from China used in the blood thinner heparin, the FDA is intimately familiar with the daunting task of policing the safety of food and medical products faced by regulators abroad. The FDA is responsible for protecting American consumers from unsafe food, medicines, biologics, and medical products that originate from many different countries and are transported through complex supply chains. Almost 40 percent of the fruits and nuts and 85 percent of the seafood that Americans purchase come from aboard. More than 80 percent of active pharmaceutical ingredients are imported, and 40 percent of medicines are imported as finished products.
U.S. law requires drug manufactures to prove safety before the FDA permits sale of their products, however many regulatory agencies abroad lack the legal framework, funding, training, and oversight that have helped to transform the FDA into one of the world’s top-notch regulatory agencies. At the request of the FDA, the IOM formed a committee to identify the core elements of food, medicine, medical product, and biologics regulatory systems in developing countries; to pin-point the main gaps in these systems; and to design a strategy to leverage the expertise of the FDA and other stakeholders to strengthen regulatory systems abroad.”Read Full Post | Make a Comment ( Comments Off on Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad – Institute of Medicine – 4 April 2012 )
The Economic Impact of the U.S. Advanced Medical Technology Industry – Prepared by Battelle Technology Partnership Practice for the Advanced Medical Technology Association (AdvaMed) – March 2012Read Full Post | Make a Comment ( Comments Off on The Economic Impact of the U.S. Advanced Medical Technology Industry – Prepared by Battelle Technology Partnership Practice for the Advanced Medical Technology Association (AdvaMed) – March 2012 )
Report: PIP breast implants and regulation of cosmetic interventions – House of Commons Select Health Committee – 28 March 2012
“The Health Committee welcomes the Government’s decision to commission two reviews following public concern about breast implant surgery, following the decision of the French authorities to recommend removal of implants sourced from PIP.
The two reviews have different terms of reference:
The first, led by Sir Bruce Keogh, is tasked with assessing the regulation of cosmetic interventions in general. Sir Bruce’s expert group will also continue to analyse the scientific evidence of risk arising from PIP implants.
The second, led by Earl Howe, is tasked with analysing the policy reaction, in particular by MHRA and DoH, to the announcement by the French authorities in March 2010 that PIP products did not comply with the requirements of their CE registration.
Following a brief inquiry into the background to these events the Committee concludes:”
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Evolution of Translational Omics: Lessons Learned and the Path Forward – Institute of Medicine – 23 March 2012
“Technologies that are collectively called omics have made it feasible to measure an enormous number of molecules within a tissue or cell; for example, genomics investigates thousands of DNA sequences, and proteomics examines large numbers of proteins. Patients look to the scientific community to develop innovative omics-based tests to more reliably detect disease and to predict their likelihood of responding to specific drugs. However, the translation of these new technologies into clinical laboratory tests that can help patients directly has happened more slowly than anticipated.
Following a recent case involving premature use of omics-based tests in cancer clinical trials at Duke University, the National Cancer Institute requested that the IOM establish a committee to recommend ways to strengthen omics-based test development and evaluation. The IOM’s recommendations speak to the many parties responsible for discovery and development of omics-based tests, including investigators, their institutions, sponsors of research, the FDA, and journals. The report identifies best practices to enhance development, evaluation, and translation of omics-based tests while simultaneously reinforcing steps to ensure that these tests are appropriately assessed for scientific validity before they are used to guide patient treatment in clinical trials. The IOM’s recommendations aim to ensure that progress in omics test development is grounded in sound scientific practice and is reproducible, resulting not only in improved health care but also in continued public trust.”Read Full Post | Make a Comment ( Comments Off on Evolution of Translational Omics: Lessons Learned and the Path Forward – Institute of Medicine – 23 March 2012 )
“The compendium of new and emerging technologies that address global health concerns has been created as a neutral platform for technologies which are likely to be suitable for use in low-resource settings. It is released to encourage the dialogue between ministries of health, procurement offi cers, donors, technology developers, manufacturers, clinicians, academics and the general public. In doing so, WHO aims at raising awareness of the pressing need for appropriate design solutions, and for further development and technology dissemination.
The compendium 2011 is a first snapshot of several health technologies which might have the potential to improve health
outcomes or to offer a solution to an unmet medical need in low-resource settings. The compendium specifi cally focuses on
innovative technologies that are not yet widely available in developing countries, and product concepts under way.
Technologies in the compendium are presented in one page summarizing the health problem addressed, the proposed solution and product specifi cations, based on data and information provided by the developers of the technologies concerned.”
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Lack of Price Transparency May Hamper Hospitals’ Ability to Be Prudent Purchasers of Implantable Medical Devices – GAO [US] – 13 January 2012
Government Accountability Office
“What GAO Found
From 2004 through 2009, expenditures for hospital IMD procedures increased from $16.1 billion to $19.8 billion, an increase of 4.3 percent per year—a rate equal to that of Medicare spending for other hospital procedures. While cardiac and orthopedic procedures accounted for nearly all IMD-related expenditures, orthopedic procedures accounted for most of the increase in such expenditures during this period. Utilization increased at a faster rate for orthopedic devices and accounted for the majority of changes in expenditures for IMD procedures during the period.
The information GAO obtained on the amounts hospitals paid for selected IMDs showed substantial variation.”
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Ultra wide band radio shows promise for body-area sensor networks – British Journal of Healthcare Computing – 25 January 2012
“[Oulu, Finland/ Implementations] – Ultra wideband (UWB) wireless technology has potential for short-range wireless communications for medical sensors worn by patients in a hospital environment, according to a study at the University of Oulu, Finland.”
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Opportunities to Promote Efficiency in Hospital Decision-Making through the Use of Health Technology Assessment – Canadian Health Services Research Foundation – 13 December 2011
by Gagnon, Marie-Pierre
■Health technology assessment (HTA) is a multidisciplinary area of applied research that produces high quality information about health technologies—drugs, medical technologies and health interventions. The HTA produces recommendations on whether a health technology should be considered, funded and adopted into practice. The goal is to use the research and recommendations from the HTA to inform decisions that will improve quality and cost-effectiveness of healthcare.
■In Canada, there are several well-established agencies at the national and provincial levels that successfully perform HTA. More and more, however, HTA units are being implemented in a local/ hospital-based setting, based on a growing awareness that the local context needs to be taken into account when assessing health technologies.
■Four different models for performing local/hospital-based HTA have been identified and are currently in use world-wide: the ambassador model; mini-HTA; internal committee; and HTA unit. Each has its own strengths and weaknesses. There is insufficient evidence available to adequately assess which of these models would be the best for Canadian hospitals.
■Research shows that local/hospital-based HTA may influence decision-making. There are reports from isolated experiences related to local/hospital-based HTA on hospital decisions and budgets, as well as positive perceptions from managers and clinicians.
■It is difficult to evaluate the overall impacts of HTA on the various levels of healthcare delivery, largely because most hospital-based HTA experiences are recent and there is a paucity of data. Further research is necessary to explore the conditions under which local/hospital-based HTA results and recommendations can have an impact on hospital policies, clinical decisions and quality of patient care.
■The potential exists to share expertise and methodologies between local/hospital-based HTA units. However, there are challenges in directly transferring research knowledge from one organization to another, given the specificity of the context from hospital to hospital.”
Poly implant prostheses (PIP) breast implants: interim report of the Expert Group, Sir Bruce Keogh, NHS Medical Director – 6 January 2012
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Code of practice could improve disability procurement [UK] – The Guardian – 23 December 2011
“A new code of practice is encouraging better procurement of disability equipment and could help commissioners
Local authorities and the NHS supply over 12m pieces of disability and other community equipment to 4 million users in the UK every year. This includes beds, postural support equipment for children, and even complex life support equipment.
No single set of regulations apply to the provision and use of equipment but various diverse and complex requirements exist making conformity in provision difficult if not impossible and ultimately it is disabled people who pay the price.
According to the Medicines and Healthcare products Regulatory Agency (MHRA) every year in the UK there are over 30 deaths and 1,500 serious incidents as a result of inappropriate and unsafe equipment supplied in the community.
If just 1% of community equipment failed to be delivered and lead to a secondary episode of care, the additional cost to the care economy would be around £5bn a year.
To address the situation, Brian Donnelly, chief executive of the Community Equipment Code of Practice Scheme (Cecops) has written a guide for commissioning and providing community equipment. It sets out codified standards for each stage of the community equipment process and comprehensively covers commissioning functions, the provision of services and clinical and professional responsibilities. The code aligns with current NHS and local authority policy changes and enables better co-ordination of services.”
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Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development – Workshop Summary – Institute of Medicine – 21 December 2011
“The development and application of regulatory science – which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products – calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining these regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency. Moreover, resource constraints and an increasingly complex workload make it difficult for FDA scientists to interact with other scientists and enhance their scientific knowledge base. Several barriers to the advancement of regulatory science have been identified – including workforce and resource constraints in all sectors, systemic barriers to collaboration and scientific exchange, and deficiencies in the regulatory science infrastructure.
In 2010, the IOM’s Forum on Drug Discovery, Development, and Translation held a workshop that examined the state of regulatory science and considered approaches to enhance it. As a follow-up to that workshop, the Forum held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and infrastructure as discussed in the 2010 workshop. At the workshop, speakers considered opportunities and needs for advancing innovation in the discipline of regulatory science for therapeutics development through an interdisciplinary regulatory science workforce and examined specific strategies for developing a discipline of innovative regulatory science through the development of a robust workforce within academia and industry and at FDA. This document summarizes the workshop.”Read Full Post | Make a Comment ( Comments Off on Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development – Workshop Summary – Institute of Medicine – 21 December 2011 )
Which Price is Right? Regulating the cost of pharmaceuticals in Europe and North America – Stockholm Network – December 2011
by Paul Healy
“This is the latest publication of the Stockholm Network`s newest programme on Health Technology Assessment (HTA) and pharmaceutical pricing. Which Price is Right? is an extensive study into the regulations around the price of pharmaceuticals in Europe and North America, identifying a pricing spectrum that balances between controlled prices set by healthcare payers and market-based prices set by manufacturers.
It argues that Europe currently finds itself in a position where it is getting “more for less” in regards to pharmaceuticals, although in doing so it relies on more market-based environments, such as the United States, to progress the research into much needed innovations. Although it may not seem so initially to policymakers, this is ultimately identified as problematic for two reasons.
Firstly, it puts European nations in a position where they can be accused of “free-riding” on patients in the US and thus not paying their fair share towards the current cost of developing medicines that are of value to the entire globe, not least to their own patients. Secondly, it means that European nations have surrendered some autonomy over their healthcare systems by placing the burden for medical innovation on the shoulders of others, whilst leaving themselves susceptible to changes in pharmaceuticals regulations over which they have no authority.”Read Full Post | Make a Comment ( Comments Off on Which Price is Right? Regulating the cost of pharmaceuticals in Europe and North America – Stockholm Network – December 2011 )
Strength and opportunity 2011: the landscape of medical technology, medical biotechnology, industrial biotechnology and pharmaceutical sectors in the UK – BIS – 5 December 2011Read Full Post | Make a Comment ( Comments Off on Strength and opportunity 2011: the landscape of medical technology, medical biotechnology, industrial biotechnology and pharmaceutical sectors in the UK – BIS – 5 December 2011 )
TGA reforms: a blueprint for TGA’s future – 8 December 2011
“The Australian Government has released its response to several major reviews of therapeutic goods regulation that have been undertaken over the past 18 months.
These reviews include:
•the review to improve the transparency of the Therapeutic Goods Administration
•public consultations on the regulatory framework for advertising therapeutic goods
•the Auditor-General’s report on Therapeutic Goods Regulation: Complementary Medicines
•an informal working group examining the regulation of complementary medicines and reasons for low compliance rates
•public consultations on the medical devices regulatory framework
•the Working Group on Promotion of Therapeutic Products
•the Health Technology Assessment Review.
The Government’s response takes into account submissions made by stakeholders, and draws this work together into a comprehensive package of reforms that will be progressed in stages.
The reforms will enhance the regulatory framework, ensuring that it remains adaptable to new scientific developments and emerging community expectations.
They will also improve the Australian community’s understanding of the TGA’s regulatory processes and decisions and enhance public trust in the safety and quality of therapeutic goods.”Read Full Post | Make a Comment ( Comments Off on TGA reforms: a blueprint for TGA’s future – 8 December 2011 )
Adding value: Assessing the economic and societal benefits of medical technologies – The Work Foundation – 15 November 2011
“As the UK workforce ages and the burden of chronic diseases in the wider population grows it is clear that access to medical interventions which help people to stay in work will become more important – both economically and socially.
Today we were very proud to launch the Work Foundation’s new report Adding value: Assessing the economic and societal benefits of medical technologies at a meeting of the All Party Parliamentary Group (APPG) on Improving Patient Access to Medical Technology in the House of Commons. This study gathered evidence that is set to challenge the current model of assessment of medical technologies in the UK.
The current schedule of assessment by NICE focuses mainly on the clinical outcomes associated with medical interventions, such as changes in rates of accident and emergency admissions, extended longevity and prolonged health-related quality of life. In the report we argue that such a perspective is very short-sighted as individuals’ health status impacts mid-term and long-term outcomes for households, healthcare system and wider society.
One of the factors that is often not assessed with regard to medical technologies is the extent to which a particular intervention supports individual ‘workability’ and continued active participation in the labour market. Our research shows very clearly that staying at work or being able to return to work also matters a great deal for a range of other stakeholders, including families, carers, employers, co-workers, and – at the macro level – taxpayers, carrying the burden of social care and welfare. Ultimately, delayed or ineffective intervention leads to skill gaps, early retirement due to disability and poor economic sustainability of the state.
Our report considers the impact of three medical technologies: artificial hip and knee replacements, implantable cardioverter defibrillators and insulin pumps, all of which may offer extended societal benefits beyond those currently considered in the health technology assessment (HTA) agenda.”
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Generic Adoption Process (GAP) – NHS Technology Adoption Centre (NTAC) – 8 November 2011
“The NHS Technology Adoption Centre, NTAC, has launched a new online tool which has been designed to enable proven medical technology to be more efficiently adopted into the NHS. The Generic Adoption Process, or GAP, provides a clear and detailed roadmap, along with the required tools to enable proven medical technologies to be adopted. The unique tool is aimed at both the NHS and private sector suppliers and consolidates NTAC’s extensive and unique learning from a range of successful ‘Technology Implementation Projects’.
GAP is one of a set of new services launched by NTAC which have been designed to speed up the diffusion of proven technologies across the NHS. These services are based on the considerable expertise and knowledge which has been built up over the last four years and are better aligned with the changing NHS and the current medical technology landscape. Led by CEO Sally Chisholm the new NTAC is building on this base of knowledge and experience with a new team of purposely selected individuals who have the skill and expertise to bring life changing technologies to NHS patients.”
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Medical technology in Australia: key facts and figures 2011 – Medical Technology Association of Australia – 8 November 2011
“Medical Technology Association of Australia (MTAA) Chief Executive Officer, Anne Trimmer today launched the Medical technology in Australia: key facts and figures 2011 booklet at the opening of the MTAA conference MedTech 2011: Medical technology – building sustainable healthcare.
“The publication provides a fascinating overview of the industry and its place in the Australian healthcare system,” said Ms Trimmer.
Ms Trimmer also announced a broader research project to survey the entire industry – any company with a medical device registered on the ARTG. The result will be a more comprehensive profile of the sector which will support MTAA ‘s push for increased recognition of the industry and its potential.”
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The Use of Health Technology Assessment to Inform the Value of Provider Fees: Current Challenges and Future Oportunities – Canadian Health Services Research Foundation – 18 October 2011
Don Husereau, Chris G. Cameron
“Health technology assessment (HTA) is becoming an increasingly prominent policy tool in response to concerns about rising healthcare costs driven by the use of technology. HTA is a multi-disciplinary process of policy analysis that aims to bridge the world of research with the world of decision-making by examining the medical, economic, social and ethical implications of the use of a health technology and their associated interventions. HTA seeks to define and measure (i.e., capture) the value of new products and services. It is currently being used in Canadian hospitals to decide what technologies to adopt and by some health jurisdictions to decide whether to create new provider fee codes. However, decisions to adopt a new technology are also driven by the need to provide consumer choice, provider autonomy, and patient access, underlying the principles of Canada’s Health Act. Additionally, not funding a new technology may provide disincentives to service providers to practice in health systems where services are not reimbursed, threatening the ability of the health system to reliably provide care and leading to additional costs if specialty services are not available. This, in turn, may harm the relationship between payers and providers.
In Canada, new codes for provider fees are developed in each jurisdiction using separate approaches and with very little coordination. This makes the Canadian health system susceptible to perceived inequities across jurisdictions and can lead to the phenomenon known as “whipsawing”—pressure to fund a service in other jurisdictions if only one province or territory is funding the service. There may also be pressure to pay the same amount of money for similar services without considering the social and economic context in which it will be delivered. This can result in unnecessary growth in health system costs.
The prices of new provider fees in Canada are largely based on costs to deliver the service and do not consider the relative value-for-money of the new service. This approach means providers have little incentive to perform high-value services compared to low-value services. HTA can play an important role in linking the price of a provider fee with a tangible value. This means that service prices can be modified upward for high-value services and downward for low-value services, averting unnecessary growth in health system costs.”
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MPs report on high value equipment in the NHS – 25 October 2011
House of Commons, Public Account Committee
“The Commons Public Accounts Committee publishes it fifty third report of Session 2010-12, on the basis of evidence from the Department of Health.
The Rt Hon Margaret Hodge MP, Chair of the Committee of Public Accounts, said:
“High value equipment in the NHS – like MRI and CT scanners – is worth around £1 billion, but the way this equipment is bought and used is not providing value for money for the taxpayer.
We were shocked by the unacceptable response times for certain conditions. A modern NHS should not allow 50% of people who have a stroke to wait more than 24 hours for a scan. There are unacceptable variations between trusts in the number of scans per machine, from 7,800 to almost 22,000 a year; opening hours and waiting times.
The Department of Health has got to look at how machines can be used more efficiently to make the best use of scarce resources.
Not enough trusts are taking full advantage of the framework agreements the NHS Supply Chain negotiates. Even where they do, money is being wasted because trusts don’t join together to buy equipment and get the best deals by exploiting their bulk buying power.
The Department of Health is accountable for securing value for money in health spending but has no way of getting trusts to work together or tell them how to buy their equipment.
At a time when the NHS has to make £20 billion of savings, it is unacceptable that money is being wasted.
The Department must set out how it is going to drive value for money in a devolved world where every trust is an independent foundation trust not answerable to the Department.
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Parsons SK et al Noninvasive Diagnostic Techniques for the Detection of Skin Cancers. Technical Brief No. 11. (Prepared by the Tufts University Evidence-based Practice Center under Contract No. 290-2007-1055-1.) AHRQ Publication No. 11-EHC085-EF. Rockville, MD: Agency for Healthcare Research and Quality. September 2011.
Background. Cancers of the skin are the most common forms of cancer. Timely diagnosis and treatment are critical to reducing the rates of morbidity and mortality. Newer noninvasive imaging technologies may assist with earlier detection.
Objective. To provide an objective description of noninvasive imaging modalities in diagnosing cancerous tumors of the skin, to proffer an analytic framework for assessing the applications of the imaging modalities, to summarize the state of ongoing research, and to delineate future research needs.
Methods. We searched the MEDLINE® database for English-language literature published between 1990 and March 2011 for selected noninvasive imaging technologies. We included all publications types and study designs. We extracted data solely from relevant abstracts. Our search also included grey literature (manufacturers’ Web sites, Food and Drug Administration’s relevant databases, and ClinicalTrials.gov), and incorporated expert input from our key informants. devices were classified as in general clinical use, limited clinical use, or investigational use, based on all available information.
Findings. We screened in 629 abstracts that were relevant to the noninvasive imaging technologies of interest. Only 11 abstracts were on randomized controlled trials. Of the devices in general clinical use, we found a total of 51 abstracts on photography and 433 on dermoscopy. Of note, only one abstract reported clinical outcomes. None of the abstracts reported adverse events. Photography is principally used in specialty and subspecialty settings (i.e., oncology) and while widely used by dermatologists, dermoscopy is still not used in primary care. We did not identify any consistent guidelines for the assessment of suspicious skin lesions. Devices in limited clinical use are principally used in research settings. Available literature was limited for these devices as well as those still considered investigational.
Summary. A review of the literature reveals predominant use of noninvasive devices by dermatologists with limited diffusion of this technology in primary care. When compared with the use of biopsy, future research is needed to evaluate the test accuracies, clinical impact, and the potential adverse events associated with the use of noninvasive imaging technologies.”
Uncertainty, evidence and irrecoverable costs: informing approval, pricing and research decisions for health technologies – Centre for Health Economics University of York – October 2011
by Karl Claxton, Stephen Palmer, Louise Longworth, Laura Bojke, Susan Griffin, Claire McKenna, Marta Soares, Eldon Spackman and Jihee Youn
CHE Research Paper 69
The general issue of balancing the value of evidence about the performance of a technology and the value of access to a technology can be seen as central to a number of policy questions. Establishing the key principles of what assessments are needed, as well as how they should be made, will enable them to be addressed in an explicit and transparent manner. This report presents the key finding from MRC and NHIR funded research which aimed to: i) Establish the key principles of what assessments are needed to inform an only in research (OIR) or Approval with Research (AWR) recommendation. ii) Evaluate previous NICE guidance where OIR or AWR recommendations were made or considered. iii) Evaluate a range of alternative options to establish the criteria, additional information and/or analysis which could be made available to help the assessment needed to inform an OIR or AWR recommendation. iv) Provide a series of final recommendations, with the involvement of key stakeholders, establishing both the key principles and associated criteria that might guide OIR and AWR recommendations, identifying what, if any, additional information or analysis might be included in the Technology Appraisal process and how such ecommendations might be more likely to be implemented through publicly funded and sponsored research. The key principles and the assessments and judgments required are discussed in Section 2. The sequence of assessment and judgment is represented as an algorithm, which can also be summarised as a simple set of explicit criteria or a seven point checklist of assessments. The application of the check list of assessment to a series of four case studies in Section 3 can inform considerations of whether such assessments can be made based on existing information and analysis in current NICE appraisal and in what circumstances could additional information and/or analysis be useful. In Section 4, some of the implications that this more explicit assessment of OIR and AWR might have for policy (e.g., NICE guidance and drug pricing), the process of appraisal (e.g., greater involvement of research commissioners) and methods of appraisal (e.g., should additional information, evidence and analysis be required) are drawn together.”
Crossroads – A Discussion Paper on Managing Medical Technology for an Assured Future – College of Biomedical Engineering – 18 August 2011
Crossroads – A Discussion Paper on Managing Medical Technology for an Assured Future – College of Biomedical Engineering – 18 August 2011
“Engineers Australia’s College of Biomedical Engineering has released a discussion paper on issues relating to the implications for Australia’s health system of current medical technology management practices. The benefits to be derived from contemporary medical technology are well recognised. Patient safety and the need for diagnostic accuracy and treatment effectiveness are critical. The Australian community expects that the medical equipment used in our system will be state of the art, safe, effective and reliable.”
Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years – 29 July 2011
“Medical devices play a critical role in the health care of Americans. They can range from simple tools, such as tongue depressors and bandages, to complex or life-saving equipment, such as pacemakers, magnetic resonance imaging machines, and heart–lung machines. The Federal Food, Drug, and Cosmetic Act (FFDCA) requires a “reasonable assurance of safety and effectiveness” before a device can be marketed, and the U.S. Food and Drug Administration (FDA) is responsible for enforcing this requirement. Devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the 510(k) process, named for Section 510(k) of the FFDCA. Some policymakers and patients have expressed concern about the ability of the 510(k) process to ensure that medical devices on the market are safe and effective. Other policymakers and patients, as well as the medical-device industry, have asserted that the process has become too burdensome and time-consuming and that it is delaying important new medical devices from entering the market.
The FDA turned to the IOM to review the 510(k) process and answer two questions:
Does the current 510(k) process protect patients optimally and promote innovation in support of public health?
If not, what legislative, regulatory, or administrative changes are recommended to achieve the goals of the 510(k) process optimally
The IOM finds that the current 510(k) process is flawed based on its legislative foundation. Rather than continuing to modify the 35-year-old 510(k) process, the IOM concludes that the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle. The IOM outlines its criteria for this framework in the report.”
Review to improve the transparency of the Therapeutic Goods Administration: Final Report – June 2011
Extract from the Executive Summary:
“The Therapeutic Goods Act 1989 states as its principal object ‘to provide for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods’ that are used in Australia or exported from Australia. This system is achieved through the operation of the Therapeutic Goods Administration (TGA), a Division of the Department of Health and Ageing.
A perception has arisen in the community that the TGA does not provide the public with sufficient information about its activities and about the therapeutic goods that it regulates. This perception led the Parliamentary Secretary for Health and Ageing, the Hon Catherine King MP, to establish a panel of consumer, health practitioners and therapeutic goods industry representatives to review and report on the transparency of the TGA.”
Online ISBN: 978-1-74241-524-6
Publications Approval Number-D0482
This guidance document is being distributed for comment purposes only.
Extract from the introduction
“The Food and Drug Administration (FDA) is issuing this draft guidance document to inform manufacturers, distributors, and other entities about how the FDA intends to apply its regulatory authorities to select software applications intended for use on mobile platforms (mobile applications or “mobile apps”).
Given the rapid expansion and broad applicability of mobile apps, the FDA is issuing this draft guidance document to clarify the types of mobile apps to which the FDA intends to apply its authority. At this time, the FDA intends to apply its regulatory requirements solely to a subset of mobile apps that it is calling mobile medical applications or “mobile medical apps.” ” … continuesRead Full Post | Make a Comment ( None so far )
NICE publishes process and methods guides for its Medical Technologies Evaluation Programme – 20 April 2011
“The National Institute for Health and Clinical Excellence (NICE) has published the process and methods guides for its Medical Technologies Evaluation Programme. This work programme focuses specifically on helping enable new medical technologies, or important modifications to existing ones, to be used more quickly and consistently in the NHS.
The process and methods guides explain how evaluations will work, and will be of particular interest to manufacturers considering notifying their device or diagnostic to the programme. The process is designed so that guidance is developed for the NHS in an open, credible, transparent and timely way allowing appropriate input from relevant stakeholders. NICE consulted on the draft guides during 2010, and received over 500 comments from a range of stakeholders including individuals and organisations within the NHS, the medical technologies industry, academia, patient organisations and the Department of Health. This substantial and valuable input has informed the guides’ development.”
Healthcare Technology Co-operatives: Filling a niche in the English R&D landscape – RAND – March 2011
Document Number: TR-932-DH
“The Department of Health (England) commissioned this evaluation of the pilot Health Technology Cooperatives (HTCs), which are part of its research infrastructure. Its purpose is to explore how this initiative has affected relationships between clinical, industrial and academic partners; how the HTCs fit into the current health innovation landscape; and the alignment of HTC activities to the goals set out in the NIHR strategy.
Since the HTC scheme was intended to focus on medical devices, this review investigated how medical device development is being pursued by other similar entities in England, Australia and the USA. The key question was whether the institutional relationships initiated by the HTCs are contributing to the health research system in England and if this scheme is the most effective way of pursuing these relationships.
This review had no specific theory or hypothesis to test, so information was gathered so as to allow key conclusions to be drawn and linked to existing theories. This review used documented evidence from the institutions involved as well as interviews.
The pilot HTCs have shown that there are different, but equally legitimate, management approaches to the clinician-industry-patient relationship. These different approaches are reflections both of the disease field and the host institution culture. Neither HTC has concluded how best to sustain activities in the long term, particularly core management facilities such as supporting initial meetings with potential partners and early development of technologies from non-commercial sources. Recommendations focussed on how best to support core HTC activities in the future.”Read Full Post | Make a Comment ( None so far )
New blood pressure measurement device to revolutionise the way blood pressure is measured – 21 February 2011
“A new blood pressure measurement device, invented by scientists at the University of Leicester and in Singapore is set to revolutionise the way patients’ blood pressure is measured.
The CASPal blood pressure measurement device gives a more accurate reading than the current method used. It does this by measuring the pressure close to the heart – the central aortic systolic pressure or CASP.
Blood pressure, currently measured in the arm may not always accurately reflect what the pressure is in the larger arteries close to the heart.” …continued on the siteRead Full Post | Make a Comment ( None so far )
NICE – SeQuent Please balloon catheter for in-stent coronary restenosis: medical technologies consultation – July 2010
“The first piece of guidance has been published from NICE’s new medical technologies programme, set up to help the NHS adopt efficient and cost effective medical devices and diagnostics more rapidly and consistently.
The draft guidance recommends the use of a balloon catheter, SeQuent Please, for patients who have suffered restenosis, a condition where the blood vessels become blocked again following a previous treatment with a stent.
The Evaluation Pathway Programme for Medical Technologies was established in November 2009 to focus specifically on the evaluation of innovative medical technologies. Its purpose is to produce guidance on the use of devices and diagnostics to speed up the introduction into the health service of those products offering significant benefits, or helping technologies to be investigated more thoroughly in research.
The types of products that are assessed under the new programme are medical devices that deliver treatment such as those implanted during surgical procedures, technologies that give greater independence to patients, and diagnostic devices or tests used to detect or monitor medical conditions.
An independent group of experts, the Medical Technologies Advisory Committee (MTAC), is responsible for deciding which medical technologies should be selected for evaluation, as well as developing the guidance itself.” … continuesRead Full Post | Make a Comment ( None so far )
Smart Technology for Health Longevity – Australian Academy of Technological Sciences and Engineering – May 2010, launched 22 July 2010
Smart Technology for Health Longevity – Australian Academy of Technological Sciences and Engineering – May 2010, launched 22 July 2010 ISBN 978 1 921388 11 8
“The key finding of this report by the Australian Academy of Technological Sciences and Engineering is that a national thrust on the development and application of smart technology for healthy longevity is vital to ensure a healthy, safe, secure and fulfilling future for the increasing aged population in Australia and the maintenance of a healthy, harmonious and prosperous society.”
“With the demographic ageing of Australia’s population, a suite of emerging innovative technologies offers the prospect of enhanced security, safety, diagnosis, treatment and physical assistance to improve the quality of life for elderly people, to help them remain at home, and to provide financial savings in aged care and medical treatment.
There is already a substantial investment in research and development capacity in this area in Australia but more needs to be done to maintain, strengthen and coordinate this activity and to ensure that public and private aged care authorities and organisations can effectively utilise the outcomes. The Australian Government has a critical role to play by promoting a National Research and Development Agenda on Technology and Ageing to complement the National Strategy on Ageing and the recently announced National Enabling Technologies Strategy.”
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Improving the Quality and Cost of Healthcare Delivery: The Potential of Radio Frequency Identification (RFID) Technology – RAND – May 2010
Improving the Quality and Cost of Healthcare Delivery: The Potential of Radio Frequency Identification (RFID) Technology – RAND – May 2010
By: Anna-Marie Vilamovska
Document Number: RGSD-239
“This study investigates whether an upcoming class of health information technology (HIT) can be used to address currently outstanding issues in the quality and cost of healthcare delivery. Expert interviews and a literature review were used to describe the 2009 universe of in- and outpatient healthcare RFID applications and to identify those applications expected to have the largest positive impact on the quality and cost-effectiveness of healthcare delivery over the next five to ten years. Next, case studies of actual RFID implementations across seven hospital sites in the U.S. and Europe were conducted to gain an understanding of how each leading RFID application type creates value, what aspects of care it impacts, and what the critical factors driving the promising RFID’s organizational benefits and costs are. As part of this work, an original set of healthcare RFID cost-benefit evaluation tools was developed and tested. The study’s findings indicate that in contrast to other types of HIT, the majority of benefits associated with successful RFID implementation are directly related to money saved (occurring as direct capital and operational cost savings), and that select RFID applications can substantially impact both the cost (e.g., efficiency) and the quality (e.g., timeliness, capacity for continuous improvement) of care delivery. Critical challenges for RFID adoption are described.”Read Full Post | Make a Comment ( None so far )
European Commission, Directorate-General for Economic and Financial Affairs
The paper concentrates mainly on the impact of non-demographic factors, in particular on the impact of technology development on health care expenditure.
The effectiveness and cost effectiveness of biomarkers for the prioritisation of patients awaiting coronary revascularisation: a systematic review and decision model – Health Technology Assessment February 2010
The effectiveness and cost effectiveness of biomarkers for the prioritisation of patients awaiting coronary revascularisation: a systematic review and decision model – Health Technology Assessment 2010 (February); Vol. 14: No. 9
Health Technology Assessment
NIHR HTA programme
Report of the Review of Health Technology Assessment in Australia – 27 February 2010
The Minister for Health and Ageing, the Hon Nicola Roxon, and the Minister for Finance and Deregulation, the Hon Lindsay Tanner, have welcomed the report of the Review of Health Technology Assessment in Australia(HTA Review).
The HTA Review has recommended key improvements to the way new health technologies, procedures and services are assessed for public and private funding in Australia, in line with international best practice. The media release is also available.
Policy options for Radio Frequency Identification (RFID) application in healthcare; a prospective view – RAND – January 2010
Policy options for Radio Frequency Identification (RFID) application in healthcare; a prospective view
Final report (D5)
By: Constantijn van Oranje-Nassau, Helen Rebecca Schindler, Maarten Botterman
Document Number: TR-767-EC
“This report reviews the state of play of European markets and applications of Radio Frequency Identification technology (RFID) in healthcare in Europe. Based on the current situation the report presents three scenarios for 2020, to describe futures in which the technology and health care sectors develop in different ways. The scenarios were discussed in expert workshops to derive issues that need to be addressed by future policies of the European Union and other stakeholders. The market assessment is based on a review of literature and an analysis of proprietary market data. The chapter on the state of RFID applications in Health in Europe summarises the results of a literature review, an online Delphi survey, expert interviews and seven cases studies in Europe and the US. The policy analysis is based on the outcomes of a scenario gaming workshop with experts from academia, industry, healthcare providers, policymakers and representatives of patient organisations.”Read Full Post | Make a Comment ( None so far )
Medical technology: can we afford to miss out? – the Medical Technology Group
“In this report, the Medical Technology Group warn that any cuts to NHS technology budgets would cost more in the long-run and risk damaging the quality of life of thousands of patients with diabetes, heart disease and other long-term conditions.”Read Full Post | Make a Comment ( None so far )
Organisational factors influencing technology adoption and assimilation in the NHS: a systematic literature review
Organisational factors influencing technology adoption and assimilation in the NHS: a systematic literature review
Report for the National Institute for Health Research Service Delivery and Organisation Programme – June 2009
“Radio Frequency Identification (RFID) HIBC for Product Identification has been given final approval by the American National Standards Institute ( ANSI). Also known as ANSI/HIBC 4.0, the new standard was developed by the Health Industry Business Communications Council (HIBCC), an accredited global standards development organization that was founded in 1983 to promote patient safety by creating industry-supported non-proprietary standards for healthcare product identification.
The RFID standard was already in early development phases when in June, 2008; the Journal of the American Medical Association (JAMA) published the results of a study of electromagnetic interference (EMI) with medical equipment and devices in critical care environments from RFID technologies. The study concluded that ultra high frequency (UHF) from RFID and UHF interfered with medical devices in 63% of the tests conducted.”Read Full Post | Make a Comment ( None so far )
The New Sentinel Network — Improving the Evidence of Medical-Product Safety
Posted by NEJM • July 27th, 2009
Richard Platt, M.D., M.Sc., Marcus Wilson, Pharm.D., K. Arnold Chan, M.D., Sc.D., Joshua S. Benner, Pharm.D., Sc.D., Janet Marchibroda, M.B.A., and Mark McClellan, M.D., Ph.D.
“In 2007, Congress directed the Food and Drug Administration (FDA) to create a new postmarketing surveillance system that will, by 2012, be using electronic health data from 100 million people to prospectively monitor the safety of marketed medical products.1 This new system is intended to complement existing systems of “spontaneous” adverse-event reporting. In May 2008, the FDA announced the Sentinel Initiative, which would “access the capabilities of multiple, existing data systems (i.e., electronic health record systems, medical claims databases).”2 The network of data systems is intended both to detect signals (i.e., higher-than-expected rates of adverse outcomes) and to confirm signals, including those suggested by other sources, and to do so rapidly and quantitatively. At a recent Senate hearing before her confirmation, FDA Commissioner Margaret Hamburg stated that close postmarketing monitoring of medical-product safety would remain a high priority during her tenure.3
Achieving these goals requires the first large-scale, truly integrated use of the electronic data that are increasingly available in our pluralistic health care system. The first hurdles are determining how best to organize the Sentinel Network, how it should operate, and what steps are needed for its implementation.”
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From bench to bedside. What role for nurses in helping the NHS make better and quicker use of technological innovations?
From bench to bedside. What role for nurses in helping the NHS make better and quicker use of technological innovations? Policy + from King’s College London issue 19, July 2009
“The adoption of innovative healthcare technologies with a proven ability to deliver increased patient benefits and significant efficiencies is perceived as slower and more variable in the NHS than other healthcare systems. Nurses are the largest workforce in the NHS and end users of much technology at the bedside. Drawing on a recently completed systematic review (1), this Policy Plus summarises what we know – and do not know – about the nurses’ role in adopting and assimilating such innovations into routine clinical care and considers the challenges for nurse leaders.”Read Full Post | Make a Comment ( None so far )
Kennedy study of valuing innovation – UK – 22 July 2009
From the press release:
“In February 2009, NICE asked Professor Sir Ian Kennedy to undertake an independent study in response to the views expressed by Sir David Cooksey in his Review and Refresh of Bioscience 2015.
Sir Ian Kennedy was asked to carry out a short study on how NICE establishes the value of innovation, and in particular to make recommendations about what approach should be adopted by NICE to ensure that innovation is properly taken into account when establishing the value of new health technologies. In undertaking the study, Sir Ian Kennedy called for submissions from interested parties, and held a series of workshops to explore the issues with individuals from the healthcare industries, healthcare professionals, the NHS, patients and the wider public. Sir Ian Kennedy’s study was also informed by the views of NICE’s Citizens Council, who considered innovation at its meeting in May 2009.
Sir Ian Kennedy presented his report at the public NICE Board meeting on the 22 July 2009. The report and further information about the study is available on the NICE website.
Professor Sir Michael Rawlins said: “We are very grateful to Sir Ian for his report on the value of innovation, and for broad confidence he has expressed in NICE and its methods. Since NICE was established we have regularly consulted on our approach to valuing the benefits of new technologies and we welcome the opportunity to focus on innovation. Sir Ian’s report raises a number of issues that NICE will need to consider. NICE’s Board will set out a formal response at its next public Board meeting in September, which will then be the subject of a three-month consultation.”Read Full Post | Make a Comment ( None so far )
“The French National Authority for Health (Haute Autorité de Santé, or HAS) was established to assist France’s public institutions in optimizing the basket of reimbursable goods and services and to help health care professionals continuously improve their clinical practice by defining best-care standards and identifying relevant tools and methods. HAS carries out single technology assessment (STA) and multiple technology assessment (MTA), assessing both the intrinsic benefit of the new technology and its effectiveness compared with that of existing technologies. A new treatment may not be covered unless it provides either improved benefit or lower cost, and STA is mandatory before a new drug, device, or medical procedure can be added to the benefit list for sickness funds. While HAS recommendations are advisory, the decision-making bodies (the Ministry of Health or the union of sickness funds) accept its findings in most cases.”Read Full Post | Make a Comment ( None so far )
Theory versus Practice: Discussing the Governance of Health Technology Assessment Systems – Stockholm Network – 3 June 2009
Theory versus Practice: Discussing the Governance of Health Technology Assessment Systems
By Paul Healy, policy analyst, Stockholm Network, and Dr Meir P. Pugatch, director of research, Stockholm Network.
“This paper examines the issue of governance of Health Technology Assessment (HTA) systems. It finds that, while there seems to be a convergence among different countries towards the HTA appraisal and review process, there are still considerable differences in the manner in which national HTA systems operate as a whole. Such differences, it is argued, ultimately lead to different outcomes and outputs of national HTA systems, not least in the context of patients’ ability to access new and innovative healthcare technologies.
Focusing on four key countries – Australia, Canada, Germany and the United Kingdom – this paper analyses some of the key elements embedded in HTA systems, which by and large affect the issue of governance of such systems.” … continues on the websiteRead Full Post | Make a Comment ( None so far )
Comparative Effectiveness Research and Evidence-Based Health Policy: Experience from Four Countries – article – June 2009
Comparative Effectiveness Research and Evidence-Based Health Policy: Experience from Four Countries
Kalipso Chalkidou, Sean Tunis, Ruth Lopert, Lise Rochaix, Peter T. Sawicki, Mona Nasser, and Bertrand Xerri
The Milbank Quarterly, Vol. 87, No. 2, 2009 (pp. 339–367)
“Context: The discussion about improving the efficiency, quality, and long-term sustainability of the U.S. health care system is increasingly focusing on the need to provide better evidence for decision making through comparative effectiveness research (CER). In recent years, several other countries have established agencies to evaluate health technologies and broader management strategies
to inform health care policy decisions. This article reviews experiences from Britain, France, Australia, and Germany.
Methods: This article draws on the experience of senior technical and administrative staff in setting up and running the CER entities studied. Besides reviewing the agencies’ websites, legal framework documents, and informal interviews with key stakeholders, this analysis was informed by a workshop bringing together U.S. and international experts.
Findings: This article builds a matrix of features identified from the international models studied that offer insights into near-term decisions about the location, design, and function of a U.S.-based CER entity. While each country has developed a CER capacity unique to its health system, elements such as the inclusiveness of relevant stakeholders, transparency in operation, independence of the central government and other interests, and adaptability to a changing environment are prerequisites for these entities’ successful operation.
Conclusions: While the CER entities evolved separately and have different responsibilities, they have adopted a set of core structural, technical, and procedural principles, including mechanisms for engaging with stakeholders, governance and oversight arrangements, and explicit methodologies for analyzing evidence, to ensure a high-quality product that is relevant to their system.”Read Full Post | Make a Comment ( None so far )
The role of HTA in coverage and pricing decisions: A cross-country comparison
Euro Observer: the Health Policy Bulletin of the European Observatory on Health Systems and Policies, v 11 no 1 Spring 2009
“Since the late 1970s, many European countries have established health technology assessment (HTA) systems to inform coverage and pricing decisions. These countries use HTA to systematically determine the relative ‘value for money’ provided by new technologies and to give providers and patients information to make treatment choices. This, in turn, serves to encourage the efficient and effective use of health technologies and to support innovation by identifying and rewarding high-value products.
This overview article explores the use of HTA in coverage and pricing decisions, with a focus on pharmaceuticals, in six European countries with established HTA systems – Denmark, England, France, Germany, the Netherlands and Sweden.”Read Full Post | Make a Comment ( None so far )
Fighting MRSA and C.difficile
* Submitted by: Cambridge Design Partnership
* Monday, 18 May 2009
“Universal Sensors, Nottingham Trent University and Cambridge Design Partnership to help in the fight against the hospital superbugs, C.difficile and MRSA.
Universal Sensors Ltd (Cambridge, UK), Nottingham Trent University (Nottingham, UK) and Cambridge Design Partnership (Cambridge, UK) have entered into a strategic alliance to develop a hand-held system to detect the hospital superbugs, C.difficile and MRSA. The collaboration is funded through the new Small Business Research Initiative (SBRI), in contracts that were awarded by the National Institute for Health Research (NIHR) under its Invention for Innovation (i4i) Programme, the results of which were announced on 15th May 2009.
The control of Health Care Associated Infections (HAIs) and improving the cleanliness of hospitals are primary objectives for the UK’s National Health Service (NHS), but reducing the incidence of HAIs from our hospitals has been a challenge. In 2008, the NHS spent £53 million undertaking a comprehensive “deep clean” of every hospital in the UK and many NHS Trusts are now reporting a decrease in the incidence of both C.difficile and MRSA as a result of this and other initiatives implemented by dedicated Infection Control teams.” … continues on the website
The Second Report, titled “Securing Eurpoe’s healthcare future: chronic disease management and health technology assessment” was presented at the conference in Prague on 18 February 2009 – now available to download.
The Initiative for Sustainable Healthcare Financing in EuropeRead Full Post | Make a Comment ( None so far )