Tag Archives: healthcare

HL7 Standards soon to be free of charge

Health Level Seven® International (HL7®), the global leader in developing interoperability standards for healthcare IT, announced its decision to make much of its intellectual property (IP), including standards, freely available under licensing terms. The landmark decision represents HL7′s commitment to the betterment of healthcare worldwide by ensuring that all stakeholders have equal access to its HIT standards. The new policy is expected to take effect in the first quarter of 2013.

“HL7′s vision is to make its collaborative, consensus-driven standards the best and most widely used in healthcare,” said Charles Jaffe, MD, PhD, CEO of HL7. “By eliminating this barrier to implementation, we can come closer to realizing our goal, in which healthcare IT can reduce costs and improve the quality of care. Coupled with increasing government demand for standards that do not require a licensing fee, our decision to move toward free standards is perfectly aligned. To this end, we have already received enthusiastic support for this decision from key healthcare stakeholders.”

“This announcement is the most significant standards development in the past decade, said John Halamka, MD, MS, Chief Information Officer of the Beth Israel Deaconess Medical Center and Professor of Medicine at Harvard Medical School. “It ensures that every stakeholder will have ready access to the content standards they need for Meaningful Use. Enormous thanks to everyone who worked on this effort.”

The volunteer-created standards and other select pieces of intellectual property will be made available to the international healthcare community after a period of careful analysis and planning by HL7, expected to take several months. In the interim, the traditional IP/membership model which includes access to, and the right to use HL7 standards, will continue to be in effect. Following completion of the analysis, HL7 expects to transition directly to a model in which use of HL7 standards and select IP is independent of HL7 membership. HL7 will continue to consult with its members to make their investment more valuable, and will seek their input to make this transition seamless and reflective of member needs.

“The IP from HL7 is crucial to achieving interoperability among healthcare providers,” said Christopher G. Chute, MD, DrPH, Chair, ISO TC215 on Health Informatics. “It enables efficient and effective care across multidisciplinary teams that increasingly are the norm for healthcare. HL7′s decision to make these resources effectively a public good is hugely welcome and will accelerate their value to society and patients everywhere. HL7 now more than ever deserves support and membership from the broader health community to ensure these resource remain state-of-the-art and freely available.”

More information on HL7 membership and standards is available at www.hl7.org.

About Health Level Seven (HL7) International
Founded in 1987, Health Level Seven International is the global authority for healthcare Information interoperability and standards with affiliates established in more than 30 countries. HL7 is a nonprofit, ANSI-accredited standards development organization dedicated to providing a comprehensive framework and related standards for the exchange, integration, sharing, and retrieval of electronic health information that supports clinical practice and the management, delivery and evaluation of health services. HL7′s more than 2,300 members represent approximately 500 corporate members, which include more than 90 percent of the information systems vendors serving healthcare. HL7 collaborates with other standards developers and provider, payer, philanthropic and government agencies at the highest levels to ensure the development of comprehensive and reliable standards and successful interoperability efforts.

Europäische Unternehmen investieren trotz Krise stärker in Forschung und Entwicklung

Dienstag, den 28. August 2012 - Führende Unternehmen in der EU gehen davon aus, dass ihre Investitionen in Forschung und Entwicklung (FuE) im Zeitraum 2012-2014 jährlich um durchschnittlich 4 % steigen werden. So das Ergebnis einer Umfrage, die die Kommission bei einigen der am stärksten in FuE investierenden europäischen Unternehmen durchgeführt hat. Die Zahlen zeigen, welche Bedeutung die betreffenden Unternehmen – trotz der aktuellen wirtschaftlichen Probleme – Forschung und Entwicklung als zentralem Faktor für ihr künftiges Wachstum und ihren Erfolg beimessen. Spitzenreiter ist die Branche der Software- und Computerdienstleistungen, die mit einem Anstieg der FuE-Investitionen um durchschnittlich 11 % pro Jahr rechnet. Unternehmensinterne Forschung und Entwicklung wird von den befragten Unternehmen als wichtigster Innovationstreiber gesehen, gefolgt von Marktforschung und damit verbundenen Tätigkeiten zur Einführung neuer Produkte.
“Dieser positive Trend bei den FuE-Investitionen der Unternehmen ist von entscheidender Bedeutung für Europas Wettbewerbsfähigkeit”, so Máire Geoghegan-Quinn, EU‑Kommissarin für Forschung, Innovation und Wissenschaft. “Diese Unternehmen sind die wichtigsten Triebkräfte der Entwicklung hin zu einer stärker wissensbasierten und intelligenteren europäischen Wirtschaft. Unser künftiges Programm für Forschung und Innovation “Horizont 2000″ wird innovativen Unternehmen weiteren Auftrieb geben.”

Was den Einfluss der Politikmaßnahmen und externer Faktoren auf ihre Innovationstätigkeit anbelangt, verwiesen die befragten Unternehmen auf die starke positive Wirkung von steuerlichen Anreizen, staatlichen Finanzhilfen, EU-Fördermitteln und öffentlich-privaten Partnerschaften auf nationaler wie auch auf EU-Ebene. Negativ auf ihre Innovationstätigkeit ausgewirkt haben sich nach Angaben zahlreicher Unternehmen der für den Schutz der Rechte des geistigen Eigentums erforderliche Zeitaufwand und die damit verbundenen Kosten. Dies bestätigt, wie wichtig mit Blick auf die Förderung der Innovationstätigkeit der Unternehmen eine effiziente Regelung der Rechte des geistigen Eigentums ist.

Von den befragten Unternehmen wurden auch Angaben dazu erbeten, welche Bedeutung die verschiedenen Wege des Wissensaustauschs für sie haben. Kooperationsvereinbarungen mit anderen Unternehmen stehen hier an erster Stelle. Von Unternehmen, die in Branchen mit hoher FuE-Intensität tätig sind, wurden an zweiter Stelle Einlizensierung/Auslizensierung und danach Vereinbarungen mit Hochschulen und anderen öffentlichen Forschungseinrichtungen genannt. Für Unternehmen in Branchen mit mittlerer oder geringer FuE-Intensität sind Kooperationsvereinbarungen mit Hochschulen und anderen öffentlichen Forschungseinrichtungen wichtiger als Lizenzvergaben. Generell zeigen die Ergebnisse, welch große Bedeutung viele Unternehmen diesen verschiedenen Wegen des Wissensaustauschs beimessen, was als Indiz dafür gewertet werden könnte, dass offene Innovation (“open innovation”) eine immer größere Rolle spielt.

Die EU-Erhebung über FuE-Investitionstrends in der Wirtschaft (“EU Survey on R&D Investment Business Trends”) wurde von der Gemeinsamen Forschungsstelle (JRC) der Europäischen Kommission (Institut für technologische Zukunftsforschung, IPTS) und der Generaldirektion Forschung und Innovation durchgeführt.

Die Ergebnisse der Erhebung basieren auf den Antworten von 187 überwiegend großen Unternehmen (von 1 000 Unternehmen mit Sitz in der EU, die im EU-Anzeiger für FuE-Investitionen der Industrie 2011 erfasst sind) (IP/11/1205 und MEMO/11/705). Die Befragung fand zwischen dem 16. Januar und dem 28. April 2012 statt.

Diese 187 Unternehmen stehen zusammengenommen für FuE-Investitionen in Höhe von fast 45 Mrd. EUR, was rund 40 % der gesamten FuE-Investitionen der 1 000 im EU‑Anzeiger erfassten Unternehmen und damit einem erheblichen Anteil an den FuE‑Investitionen der europäischen Unternehmen entspricht. Mit durchschnittlich 4 % ist der Anstieg etwas geringer ausgefallen als in der vorangegangenen Erhebung erwartet (5 %), was auf die Verschlechterung der wirtschaftlichen Rahmenbedingungen zurückzuführen ist.

Noch vor Ende 2012 wird die Europäische Kommission ihren nächsten EU-Anzeiger für FuE-Investitionen der Industrie veröffentlichen, der eine Rangfolge der weltweit größten in FuE investierenden Unternehmen enthält.

Die Erhebung kann auf folgender Website eingesehen werden: http://iri.jrc.es/reports.htm

Quelle: http://europa.eu

Proactive publication of clinical trial data – discussing the way forward

09/08/2012 – The European Medicines Agency has announced that it will proactively publish clinical trial data and enable access to full data sets by interested parties. A number of practical and policy issues need to be addressed before complex data sets can be made available.

The Agency is organising a workshop on 22 November 2012 to listen to the views, interests, and concerns from a broad range of institutions, groups and individuals. Results from the workshop will help the Agency define the modalities of proactive access to clinical trial data, in a way that best serves patients and public health in an open and transparent forum.

Registration is open until 31 October 2012. Expressions of interest should be sent to ctdataworkshop@ema.europa.eu by 31 October 2012. Places are limited to 150 and will be offered on a first-come-first-served basis.

Source: EMA News and press releases - http://www.ema.europa.eu

Wikipedia project takes on global healthcare information gap

English Wikipedia has more than 25,000 medical articles, which receive approximately 200 million page views a month. The encyclopedia is one of the foremost health care resources in the world, used by the lay public as well as professionals. Surveys have found that between 50 and 100 percent of physicians use Wikipedia in their clinical practice, and Wikipedia is consistently at the top of Google web searches for medical terms.

Wikipedia’s Medicine Translation Task Force is an initiative established in late 2011 to make sure that the content readers are finding is accurate, unbiased, and accessible. As part of this endeavor, the task force is taking 80 core medical articles–articles like cancer, malaria, HIV/AIDS, and tuberculosis–and improving their quality to a good article or featured article status through a process of peer review by task force participants. Though 80 might not seem like much, these articles are very popular, with over 10 million page views per month. Eventually they hope to have these articles formally peer reviewed, published in the journal Open Medicine, PLoS Medicine, or the Journal of Medical Internet Research, and then ultimately indexed in PubMed. The first article is already in the publication process.

The ultimate goal is to provide health information for every person on the planet in the language of their choice. One of the biggest challenges has been reaching out to the often ignored non-English demographic.

“The only viable platform to get health care information out to the whole world is Wikipedia,” said Dr. James Heilman, an editor and English Wikipedia administrator (Jmh649). Heilman, or “Doc James” as many people refer to him, is the founder of the task force. “I asked myself, ‘How can I get high-quality health care information to everyone in the world?’”

A plan developed to take the improved English Wikipedia articles and translate them into the multiple language versions of Wikipedia. Heilman sought out Translators Without Borders (TWB) a non-profit whose mission is to provide humanitarian translation for other non-profits and NGOs worldwide. The initial goal of TWB’s inolvement is to take the 80 peer-reviewed, core articles and translate them into 80 different languages.

Lori Thicke, co-founder of Translators Without Borders, said partnering with Wikipedia would help “bridge the language last mile for access to high quality health information.”

“Wikipedia has the reach to make a major impact on public health in the developing world. Because of language and physical barriers, the health information we take for granted is locked away from the people who need it most — those with the deadly combination of relentless poverty, a high disease burden and grossly inadequate health resources,” said Thicke. “Yet these people are connected. Increasingly their phones are Internet-enabled and they are ready to move into the digital age. We need to help them.”

While the task force aspires to translate content, another goal is to do so at a level of complexity that is accessible for every reader. Heilman and Thicke enlisted the support of Content Rules, a company that specializes in professional simplification of technical content. Although they typically focus on information technology, Content Rules offered to take on simplifying the entire first batch of 80 medical articles (13 have been simplified as of this writing).

“When people can actually read medical information and understand it, it can save lives,” said Content Rules CEO Val Swisher, who put a call out for pro-bono editors to work on the Wikipedia medical articles in late 2011. “The response I got from my network was so overwhelming that I literally had to turn people away.”

Swisher explained that although the articles are outside the core area of her company, Heilman is there to review them and Content Rules does have some medical experts on staff. “Our purpose is to take deep medical information and make it understandable,” said Swisher. “So, if we don’t understand it, then we have to rewrite it. And if we do understand once we are done, then we know we’ve been successful.”

Once the simplified articles have been translated, Heilman and the task force members search for Wikipedia editors who can integrate that content into their own language version of Wikipedia. Heilman said he is currently on the lookout for editors from the Dari, Turkish, Polish, and Vietnamese projects, as well as any others who think they can help.

“No one else is attempting to solve the problem of delivering medical information in the other 280 plus languages we work on,” said Heilman. “We need to make sure that when the next billion people come on line — those who don’t speak English, Spanish, or French — that there’s something there for them.”

(You can monitor the progress of the translations here or sign up to become involved here. For further reading, see the Wikipedia Signpost’s coverage of WikiProject Medicine)

Source: Wikimedia blog, 9 August 2012
Author:  Jake Orlowitz

 

 

Translators Without Borders Newsletter II

  Click on the image below to read the original newsletter in your browser

International IT Regulations and Compliance. Quality Standards in the Pharmaceutical and Regulated Industries

Research and Markets has announced the addition of John Wiley and Sons Ltd’s new report International IT Regulations and Compliance. Quality Standards in the Pharmaceutical and Regulated Industries to their offering.

After taking part in an EU Leonardo da Vinci project to create a complete curriculum for a Master’s degree in IT Validation, Siri H. Segalstad decided to write this book as she realised there was a need for a comprehensive book that rings together current thinking on the implementation of standards and regulations in relation to IT for a wide variety of industries.

This text allows the readers to acquire not only knowledge but also understanding of quality thinking and to apply this knowledge. It will allow them to use the Quality Management System (QMS) as a tool for further development in their organization and to assess QMS from other companies during a supplier audit.

This book will enable the user to understand the process of validation, how to divide validation into manageable pieces, and what is included in the validation for different types of systems.

Topics covered include:

- Quality standards
- Regulatory requirements for IT systems
- Quality Management Systems-QMS
- Organization for an IT system
- Legal implications of an IT system
- Advanced quality management systems
- Validation process and validation techniques
- Validation of IT systems
- Risk assessment and risk management
- Laboratory Information Management Systems (LIMS) and Building Management Systems (BMS)

This comprehensive text will be useful to those working with quality assurance and validation of IT systems and in regulated industries, regardless of which standards they are using.
For more information visit Research and Markets

Source: John Wiley and Sons Ltd
Business Wire 
Source: Pharmiweb.com

New pharmacovigilance legislation comes into operation

Better protection of public health through strengthened EU system for medicines safety

02/07/2012 - The European Medicines Agency (EMA) welcomes the start of new European Union (EU) legislation on pharmacovigilance. This new piece of legislation aims to promote and protect public health by strengthening the existing Europe-wide system for monitoring the safety and benefit-risk balance of medicines.

“The progress made in healthcare would not have been possible without medicines and the research and development community behind them. But we need smart regulation for the system to be able to continue to deliver safe and effective medicines,” said the Agency’s Executive Director, Guido Rasi.

“The new pharmacovigilance legislation will help us to make the system more robust for public health and more transparent. It gives regulators a range of new or improved tools to ensure that patients are not exposed to unnecessary risks when taking medicines. It also increases the efficiency of medicines regulation for the benefit of all stakeholders.”

The new legislation was proposed by the European Commission in 2008 and adopted by the European Parliament and the Member States in December 2010. Highlights of the new legislation include:

  • establishment of a new scientific committee, the Pharmacovigilance Risk Assessment Committee (PRAC);
  • clarification of the roles and responsibilities of all actors involved in the monitoring of the safety and efficacy of medicines in Europe and strengthened coordination, leading to more robust and rapid EU decision-making;
  • engagement of patients and healthcare professionals in the regulatory process, including direct consumer reporting of suspected adverse drug events;
  • improved collection of key information on medicines, e.g. through risk-proportionate, mandatory post-authorisation safety and efficacy studies;
  • more transparency and better communication, including publication of agendas and minutes of the PRAC and the possibility to hold public hearings.

The Agency is ready for the first meeting of the PRAC on 19 and 20 July 2012. All Member States have nominated their members. The European Commission has appointed six independent scientific experts who will also serve as members. The nomination of PRAC members representing patients and healthcare professionals will follow a new public call for expressions of interest.

Information about the roles and the functioning of the PRAC has been published today and can be found on the Agency’s website, together with more information about the new pharmacovigilance legislation.

Notes
1. This press release, together with all related documents, is available on the Agency’s website.
2. More information on the new pharmacovigilance legislation is available here.
3. The status report ‘Countdown to July 2012: the Establishment and Functioning of the PRAC’ is available on the Agency’s website.
4. The new pharmacovigilance legislation is comprised of Directive 2010/84/EU and Regulation (EU) No 1235/2010.
5. More information on the work of the European Medicines Agency can be found on its website

Registration open for the 2013 IMIA Conference

Registration Opens for the January 2013 International Medical Interpreting Conference: Guadalupe Pacheco, from the Office of Minority Health, USHHS is Keynote Speaker

The International Medical Interpreters Association is happy to announce that Guadalupe Pacheco, Senior Health Advisor to the Director Office of Minority Health Office of the Secretary, U.S. Department of Health and Human Services is the keynote speaker and will speak on the revised National Standards on Culturally and Linguistically Appropriate Services (CLAS) as well as the National Stakeholder Strategy for Achieving Health Equity. “The 2013 IMIA Conference will provide a forum to hear national and international perspectives on the emerging practices of providing quality interpretation services to a growing global village,” said Guadalupe Pacheco.

Medical interpreters have been benefiting from an annual conference since 1996. The field of medical interpreting has grown in ways that few could have predicted. Innovative approaches have evolved into common practices that are being widely disseminated and adapted. Several standards and language access policies have been adopted at the state, national and international levels, spreading awareness about the importance of accurate communication and interpreting services to reduce health care disparities due to language access.

Registration just opened, and for the first time the IMIA has added a super early bird rate that expires July 15th, 2012. IMIA is encouraging early registration, which helps interpreters and other stakeholders better budget their trips. IMIA recommends the following to attendees: register first, book a hotel second, and buy the tickets last, as rates are not always cheaper earlier.

This IMIA led 3-day event has expanded and in just seven months will take place in Miami Beach Florida. “It was important to take the conference out of Boston to bring it to interpreters in other areas”, said Izabel Arocha, M.Ed., CMISpanish, and Executive Director of IMIA, “and Miami Beach seems like a great place to start”. The theme of the conference is Specialized Interpreting-Getting Beyond the Basics: Exploring Quality Interpreting for Multiple Specialtiesreflects on the in-depth level of skills and knowledge asked for by interpreters, and shared at the event.

It will take place in sunny Florida on January 18 – 20, 2013 at the Miami Beach Convention Center. “Florida is a state that is in constant motion and is more diverse than people think due to international tourism, medical tourism, and new residents from all over the world. There is a need for medical interpreters in many more languages, in addition to Spanish. We are happy to work in collaboration with IMIA to make this event a success”, said Gio Lester, President of the Association of Translators and Interpreters of Florida (ATIF). Panels and forums offer interactive discussion on relevant topics of the day, as well as over sixty very interesting workshops for interpreters, from Demystify Simultaneous Interpreting to New Trends in the Provision of VRI Services. To learn more about the conference, and to register, please visit the IMIA website .

About IMIA

The International Medical Interpreters Association (IMIA) is an umbrella association that promotes all standards and best practices in the field of medical interpreting. As an international non-profit organization of medical interpreters, it represents over 2,000 practicing medical interpreters as the ultimate experts in medical interpreting and as the best option for equitable care for minority language patients around the world. It promotes language access as a human right. The IMIA contains the only free international registry of medical interpreters, where they can be found by language, state, or country.

About ATIF

The Association of Translators and Interpreters of Florida-ATIF, a Chapter of the American Translators Association, is a 501(c)6 non-profit professional association incorporated in the State of Florida. Our association was established to provide support to professionals, students and end users of translation and interpreting services. ATIF is dedicated to promoting professional recognition and growth opportunities through educational and training initiatives targeting T&I professionals in the State of Florida. Website: http://atifonline.org

Source: IMIA – imiaweb.org
Photo: IMIA
Event schedule: http://www.imiaweb.org/uploads/pages/682..pdf

Event: “Cloud and Social Networking in Healthcare: What are the leaders doing?”

9 July 2012, London, United Kingdom.

Friday, June 15th – DocCom, provider of the first cloud-based enterprise social networking platform exclusively for healthcare, today announces that it is partnering with Microsoft to co-host an exclusive event for healthcare professionals that will explore the practical issues, potential pitfalls and transformative opportunities of cloud and social networking for healthcare. The half-day forum, entitled “The Cloud and Social Networking in Healthcare: What are the leaders doing?” is being held on Monday 9th July at Microsoft’s London offices in Cardinal Place. Attendance is encouraged from Medical Directors, CEOs and CIOs from NHS Trusts, and frontline clinicians and healthcare managers are also welcome to attend. Spaces are strictly limited and can be reserved by emailing events@doccom.info to register.
DocCom and Microsoft are hosting this key event to provide healthcare decision-makers with expert analysis of the practical application and benefits of cloud and social technologies in a clinical context, offering clear guidance on how healthcare organisations can harness the future of secure healthcare communication. DocCom will be presenting an overview of its cloud-based enterprise social networking solution for healthcare, which is built on the latest Microsoft Development Stack for enterprise grade security and compliance. The half-day session will feature key user case studies from DocCom’s customers, including Peter Aitken, Lead for Improvement at NIHR CLAHRC Southwest Peninsula, who will talk about the importance of Insight when trying to change human behaviour in healthcare; Kevin Cleary, Medical Director East London NHS Foundation Trust and Former Medical Director NPSA, who will be demonstrating how networks can improve safety by disseminating safety information; and Dr Clare Wedderburn, Associate Dean at Dorset GP, who will be exploring how the new relationships between acute and primary care will impact coordination and communication. With a strong focus on security and information governance issues, Nick Umney, Technical Specialist for Cloud at Microsoft, will give his insight on the opportunity cloud presents for healthcare, while Dr Jonathan Bloor, co-founder and medical director of DocCom and Dr Jonathon Shaw, co-founder and managing director of DocCom, will share their vision of how secure social networking can be used to make healthcare a safer and more efficient place.

Founded by doctors, DocCom is taking the very best social networking technology and applying it to the unique requirements of healthcare professionals – empowering healthcare teams to securely find, collaborate, communicate and share with each other effectively, and giving healthcare organisations the tools and insight to solve specific business problems in safety and efficiency. A 2011 NHS staff survey revealed that only 26 per cent of respondents felt that communication between senior managers and staff is effective, and less than a third (30 per cent) reported that senior managers act on feedback from staff. This backs up research carried out by DocCom which found that 90 per cent of Medical Directors have a problem communicating with their doctors. This frustration, caused by the lack of fit-for-purpose online communication platforms, has led to some staff taking the initiative to engineer their own “workaround” solutions, including use of third-party, non-healthcare-specific software and, in some cases, inappropriate use of social networking platforms such as Facebook – with potentially calamitous implications for data protection and patient confidentiality.

“Social networking and cloud technologies are now a fact of modern life, and innovators in the healthcare industry are now realising that these platforms can deliver immense benefits to healthcare teams, if harnessed in a secure, reliable and responsible way,” comments DocCom co-founder and medical director Dr Jonathan Bloor. He continues: “Effective communication saves lives, time and money. The impact of the human and financial costs associated with the poor organisational and cross-industry communication in healthcare is being clearly felt across all levels of healthcare delivery, from frontline staff to senior management. This event is aimed at helping medical directors and healthcare IT professionals to understand how an enterprise social networking system that is fully standards-compliant – and supported and endorsed by key healthcare management – can significantly improve clinical safety and efficiency within their own organisations.”

About DocCom
DocCom provides the first enterprise networking solution specifically designed to help healthcare professionals to connect, communicate and collaborate. DocCom is combining the best attributes of social and enterprise networking to create secure, cloud-based, healthcare-focused tools that can be accessed anytime, anywhere, and via any device – supporting busy people delivering critical care. DocCom’s secure software solutions are designed by doctors who understand the unique privacy and operational challenges involved – making life easier for healthcare teams and clinical practice safer and more effective.