Friday, October 12, 2012

WHO Forum on Health Data Standardization and Interoperability

Transmitting personal or population data across ICT-driven health information systems requires adherence to health data standards and related technology standards for secure, accurate and timely exchange of data for healthcare decisions. The eHealth unit within the Department of Knowledge Management and Sharing at the World Health Organization is leading the interoperability in collaboration with technical programmes and member states.


Thursday, October 11, 2012

Call for Papers/Presentations: The Food and Drug Administration in the 21st Century

Call for Papers/Presentations: The Food and Drug Administration in the 21st Century

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our annual conference, this year entitled: “The Food and Drug Administration in the 21st Century.” This one and a half day event will take place Friday and Saturday, May 3-4, 2013, at Harvard Law School in Cambridge, Massachusetts.

The Food and Drug Administration, the US government’s oldest comprehensive consumer protection agency, bears the monumental task of safeguarding the public health through regulation of food, drugs and biologics, devices, cosmetics, animal products, radiation-emitting products, and now, tobacco. The agency faces a number of perennial issues related to funding, relationships with industry, and striking the proper balance between consumer choice and consumer protection. It also faces several modern challenges related to globalization, novel technologies, newly added responsibilities, and changing threats to the public health.

How is the agency faring in the 21st century? What are the greatest challenges to the FDA’s success, and what does success look like? What lessons has it learned and how can it best meet the challenges of today? Should we keep the agency we have, pull it apart, or rebuild from scratch? This conference is meant to gather leading experts from academia, government, and private industry to evaluate the FDA based on these and other questions, and to begin charting a course for the agency’s future.

We would welcome papers for presentation on the following topics:

• Funding challenges (inadequate appropriations, user fees, pre-market review, FDA Safety and Innovation Act, etc.)

• The agency’s independence (relationship with industry, advisory boards, use of special government employees, etc.)

• Relationship of FDA to other agencies with regard to areas of duplication and gaps in coverage

• Clinical trials (representative sample populations, outsourcing, etc.)

• Post-market safety of drugs and devices

• The future of 510k medical devices

• Comparative effectiveness research and standards

• Regulation of new and/or challenging technologies, such as:

o Personalized medicine

o Stem cell therapies

o New diagnostics and direct-to-consumer genetic tests

o Combination products

o Follow-on biologics

o “Mobile medicine,” e.g., smart phone apps

• Drug shortages

• Pharmacy compounding

• The status of “grandfathered”/DESI drugs

• Incentive programs (Generating Antibiotic Incentives Now Act, accelerated approval, vouchers, pediatric and orphan exclusivity, etc.)

• Safety of the food supply (contamination, recalls, terrorism, pesticides, hormones, implementation challenges with the Food Safety Modernization Act, etc.)

• Food labeling (organic products, GMO and “natural” foods, ingredient and calorie lists, any role FDA might play in combatting the obesity epidemic, First Amendment issues, etc.)

• Regulation of cosmetics (and cosmetic drugs/devices)

• Globalization (harmonization, international manufacturing, international trials, etc.)

• Preemption and regulatory federalism

• Enforcement activities

This list is not meant to be exhaustive, and we also welcome paper presentations related to the conference’s general theme but not specifically listed above.

How to Participate

If you are interested in participating, please send an abstract of the paper you would plan to present to as soon as possible, but not later than Monday, December 10, 2012. If your abstract is selected, your final paper will be due in late March 2013, and you will be assigned a presentation slot for the conference dates. We will pay travel expenses for presenters who must travel to Cambridge.

In the past, we have successfully turned some of our conferences into edited volumes (with Oxford and MIT Press). If such a volume arises out of this conference, authors will have the option (but are not required) to publish their paper with us.

How to Register

We will post registration information on our website in 2013.


Please contact Holly Fernandez Lynch, Executive Director, Petrie-Flom Center, with any questions:, 617.384.5475.

Promotion of Law incubators in FP7 Call 10 Objective ICT-2013.11.5

Sub-objective "c" aims at developing bridges between ICT SME, start ups, young entrepreneurs, and law students through the setting up of "law incubators". A "law incubator" functions as a pro-bono legal clinic where law students are challenged to give legal advice (under the supervision of their Professors) to companies and start-ups having to deal with the complexity of legal issues related to information and communication technologies. The law incubators are by no means substituting the legal expertise of a dedicated legal consultancy made by professional lawyers. They rather aim at building the ecosystem for potential and emerging European tech companies by: • providing tech start-ups with legal support to start them off as viable and job-creating businesses; • providing practical training to the next generation of lawyers to address the broad and evolving needs of tech ventures. The applying consortia are ideally composed by a group of Universities in Europe plus some entities with direct access to start-ups, tech entrepreneurs, spin-offs of universities and research centres, European funded R&D projects, etc. (this list being neither exhaustive nor mandatory).


First European Directory of Health Apps recommended by Patients and consumers

This unique Directory contains facts about 200 smartphone health apps capable of helping patients self manage their medical conditions. The apps are categorised according to the service they provide, language in which they are available, price and links where they can be downloaded.


Online privacy and online business: An update on Do Not Track

The Centre for European Policy Studies (CEPS), Brussels, 11 October 2012


Tuesday, October 9, 2012

Final results of the CLEAR project

CLEAR (Clinical Leading Environment for the Assessment of Rehabilitation protocols in home care) is a project funded under the ICT Policy Support Programme – CIP-ICT-PSP-2007.2.2 – ICT for Ageing Well. Under this project a large scale Pilot study has been conducted in four Member States of the European Union (Italy, Spain, The Netherlands, Poland) to demonstrate the feasibility of a Tele-rehabilitation service using Habilis, a general-purpose software platform.


Made in Europe – how EU research and innovation helps our society

'Made in Europe' event, European Parliament Brussels, 8 October 2012


Feasibility Study on Statistical Methods on Internet as a Source of Data Gathering (SMART 2010/030)

Citizens and enterprises increasingly leave behind ‘digital footprints’. By ‘mining’ these footprints it is possible to describe a wide range of socio-economic phenomena in near real-time.


Follow online workshop "European Innovation Partnership on Active and Healthy Ageing: The Opportunity for regions", Tuesday 9 October at 11.15

The workshop will serve, on the one hand, as a sounding board to engage regions in this initiative and, on the other hand, to present smart specialisation strategies for innovation at regional level by investing in innovative solutions for active and healthy ageing. Concrete examples and good practice cases from cohesion policy programmes from across Europe will be presented as well as presenting the current status of the EIP actions that are being shaped to showcase the various ways regions can tap into the opportunities of the EIP and cohesion programmes. The workshop will be covered via twitter; questions and comments can be submitted as of now via hash tag #eipopendays.


Commission leads by example at conference showcasing 21st century IT solutions

On 4 and 5 October over 800 IT specialists and policy managers from EU institutions and agencies will attend the European Commission ICT Conference 2012, helping to lay the digital foundations for 21st century EU administrations. Social media, mobile ICT and other 21st century developments are offering EU administrations possibilities and tools undreamed of by public servants of previous generations. New trends in technology coupled with highly IT-literate societies across the Union are having a huge impact - both on citizens’ expectations and the demands placed on administrations.


The Second INTEGRATE Newsletter is out

The INTEGRATE project aims to develop innovative infrastructures to enable data and knowledge sharing and to foster large-scale collaboration in biomedical research. INTEGRATE flexible infrastructure components and tools will bring together heterogeneous multi-scale biomedical data generated through standard and novel technologies within post-genomic clinical trials. It will also provide a seamless link to existing research and clinical infrastructures, such as clinical trials management systems, eCRFs, and hospital EHRs. Partially funded by the European Commission under the 7th Framework Programme, INTEGRATE is coordinated by a Consortium of six partners from different European countries. Each partner brings to the project its own expertise ranging from healthcare technology to clinical research coordination.


Digital Agenda: Commission proposes over €9 billion for broadband investment

With a proposed budget of up to €50 billion between 2014-2020, the whole Connecting Europe Facility (CEF) (see IP/11/1200) is specifically designed to promote growth, jobs and competitiveness through targeted infrastructure investment at European level. It will support the roll-out of high-performing, sustainable and joined-up trans-European networks in the fields of transport, energy, and broadband & digital services.


Summary of projects from the Ambient Assisted Living Joint Programme

This catalogue provides an overview of the 102 projects that have resulted from the first four calls published by the the Ambient Assisted Living Joint Programme (AALJP). This is an insight into the products, systems and services that are being developed by hundreds of small and medium enterprises, research, user organisations and others, throughout Europe. The AALJP is a funding activity that started in 2008, it aims to create better condition of life for the older adults and to strengthen the industrial opportunities in Europe through the use of information and communication technology (ICT). It carries out its mandate through the funding of across-national projects (at least three countries involved) that involves small and medium enterprises (SME), research bodies and user’s organizations (representing the older adults).


Workshop: Improving Transparency in Government Decision Making

This is an open event intended for Member States, policy-makers and practitioners interested in improveming the transparency of government decision making at European, national and local level and anyone interested in the area of public administrations as well as businesses and/or citizens who interact with them: eGovernment project implementers, stakeholders in FP6 and FP7 research projects, researchers, businesses, ePractice members etc. This event is all about networking. A few selected speakers will set the scene with a 15 minute presentation and the rest of the programme will be dedicated to roundtable discussions and networking purposes.


Europe Fall 2012 - Last call for applications to speak at Health2Eu conference

The event will reconvene the key Health 2.0 stakeholders in Europe: health entrepreneurs, IT solution providers, health professionals, patient organizations, health authorities, public and private insurance organizations, medical devices and pharmaceutical companies, telecom groups, VC and financiers, policy makers, academics…


Spanish eHealth Tour

TICBioMed and other eHealth associations organize a tour in 7 Spanish regions to present the latest eHealth innovation to local healthcare stakeholders. SMEs are invited to showcase their solutions in order to gain visibility and get feedback from clinical professionals and managers.


EU-funded research to make the "cloud" greener

A special 3D microchip, being designed by an EU-funded research project, looks set to drastically cut the electricity and the installation costs of servers in cloud computing data centres, cementing Europe's place as the home of green computing. Cloud data centres – thousands of computer servers in one location - can be the size of football fields and consume the same amount of electricity as 40,000 homes. The data centres are essential because they enable the cloud computing revolution: consumer services like Facebook, Gmail, Spotify and mobile apps, and business services like customer databases


Safer Internet Forum 2012 - Creating together a Better Internet for Children and Young People

The Safer Internet Forum is the main European Conference on online safety issues since 2004. It gives young people the opportunity to express how they see the internet and new technologies, what they mean for them and how they influence their lives. Parents' and teachers' representatives will also attend, together with many industry representatives, law enforcement authorities, child welfare organizations, researchers and policy makers. This year's theme of the event is "Creating together a Better Internet for Children and Young People".


Now available for comments: Updated Working Draft of Website Accessibility Conformance Evaluation Methodology (WCAG-EM)

WCAG-EM describes an approach for evaluating how websites - including web applications and websites for mobile devices - conform to Web Content Accessibility Guidelines (WCAG) 2.0. It covers different situations, including self-assessment and third-party evaluation. It is independent of particular evaluation tools, web browsers, and assistive technologies. This draft has proposed content for all sections. Now is a good time to review it. In particular, feedback is sought on the applicability of this methodology in practice and for input on refining and expanding the guidance provided.


Smart Connected Electro-Mobility event, Vitoria-Gasteiz [ES], Tuesday 2 October 2012

A study on Cloud and Service Oriented Architectures for e-Government (SMART 2010-0074) – FINAL REPORT

The objective of this study was to identify ‘Fundamental Services’ in the context of new "Universal or Global" SOA SOA approaches to the provision of eGovernment services. The key questions which it addressed were: at which level of granularity can ‘Fundamental Services’ be defined?


Building the Connected Continent

High Level Conference on Digital Agenda for Europe, Sofia, 20 September 2012


Study on analysis of the needs for cross-border services and assessment of the organisational, legal, technical and semantic barriers (SMART 2011-0074)

On the basis of already existing cross-border e-government pilot services and other EU initiatives, the study aims to explore and substantiate the existing and future needs (including socio-economic, environmental, legal and even sector-specific needs) and demand for cross-border e-government services. It will carry out an in-depth quantitative and qualitative cost-benefit analysis to demonstrate how cross-border e-government services can make mobility in the EU less burdensome, provide added value to citizens and businesses and why deployment of new cross-border public services is needed. The study will identify and assess the organisational, legal, technical and semantic barriers that hinder the deployment of cross-border e-government services in the EU and consider their solutions. As a conclusion, the study will identify and propose options for the development of cross-border public services with the highest potential impact. Contract signed with Capgemini Nederland BV in partnership with Time.Lex BV CVBA, Tech4i2 Ltd and Universiteit Antwerpen on 21.12.2011 under the Contract No 30-CE-0455872/00-78. The contract runs for 13 months.


Interested to know what EU regions are doing in your field? Want to share your good practice? Join the RegioNetwork! @EU_Regional

RegioNetwork is an on-line collaboration platform for representatives of European regions and others who are interested in the European Union's regional policy. The platform offers you the possibility to participate to various groups on different topics (such as eHealth, Smart Cities, Jobs and Growth, Public Services, etc) to share your good practices, to check what's going on in your region or to tell people what you are doing in your region and to follow/interact with people. Don't miss this opportunity to discover what's around the corner and express yourself!


Digital Agenda for Europe: Reality or still a challenge

The conference aims to outline the activities along the guidelines of the “Digital Agenda for Europe” that will help the countries in the region to transform one of its weaknesses into an advantage and overcome the gap in connectivity at national and regional level. Special guest of the event will be the EU Commissioner responsible for the Digital Agenda and Vice-president of the European Commission Neelie Kroes, who will inaugurate the conference. In addition, Bulgaria will host the next Digital Champions meeting which will take place alongside the conference in Sofia.


Study on Impact assessment for legislation on mutual recognition and acceptance of e-Identification and e-Authentication across borders (SMART 2011/0075 Final Report)

The study provides a coherent analysis of regulatory, institutional, organisational and technological issues related to the development of interoperable cross-border eIDs. Furthermore, it considers the four options in terms of their potential impact on the development of the digital single market in general, and of their support to the cross-border access to public services. The different options are compared with the specific development goals of current policy initiatives.


Telemedicine / Telecare: Revolutionizing Healthcare in Denmark

Denmark is one of the leading countries in the field of telemedicine and telecare. In recent years, there have been a number of projects aimed at assessing the benefits of using these kinds of technologies within hospital and homecare environments.


Easy-to-Read on the Web - Online Symposium

The W3C WAI Research and Development Working Group (RDWG) organises this online symposium on Easy-to-Read on the Web. It aims to bring together researchers, practitioners, content authors, designers, and developers, and users with disabilities to explore the needs of people with cognitive disabilities or low language skills. It is intended to encourage the development of better guidance, support, and tools for developers, designers, and users, and to inform researchers, standards developers, and policy makers on how to better address easy-to-read on the Web. A call for papers has been launched (deadline: 12 October)


Plug your energy leaks

Like water from a faulty tap, power leaks from all electronic devices – whether in use or not. The fact is a portion of our energy bill goes down the drain because the existing microchips are not very efficient. As we find out in this programme, the electronics of tomorrow will use much less power. The programme first look at a research project that tries to cut that energy bill with smarter air conditioning.


'JHI Connected Care Challenge #Europe' for #start-ups and #SMEs registration deadline 17/09/2012

First start-up and SME Challenge to spur innovation and drive action towards achieving better care and better health at lower cost through continuous improvement. We know greatness is achieved when we work together, and we are committed to playing a pivotal role in invigorating the marketplace of ideas. 30.000€ in prizes will be awarded to entrepreneurs with the best solutions under 3 selected categories. Submissions will be reviewed, and a number of participants will be invited to participate in the Challenge Final on the 5th of November in Berlin, to be held in conjunction with the Health 2.0 Conference.