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The global pharmaceutical industry tightening code of practice

March 1st, 2012 - (IFPMA) - Healthcare Regulatory update


The global pharmaceutical industry is tightening its code of practice in a bid to stamp out bribery and corruption, particularly in emerging markets.


The 2012 IFPMA code revision extends the rules covering drug company behavior to also include interactions with medical institutions and patient organizations, as well as healthcare professionals, such as prescribing doctors.

Unrestricted grants

March 1st, 2012 - (ESC Board) -Healthcare Regulatory update

“Unrestricted grants” may be a way forward, where money is given with no say in how it is spent in terms of education or course content.


Industry funding toward continuing medical education (CME) remains essential, according to a new white paper on the subject from the European Society of Cardiology (ESC), published in the March 2012 issue of the European Heart Journal.


Delivering high-quality unbiased medical education funded by grants from pharmaceutical companies has always been perceived as a delicate issue.


Some say there may be better models that could be preferable in terms of ensuring complete independence of the educational programs produced.


We can dream about an ideal world where industry would be completely eliminated from CME. Nevertheless CME is expensive and relying completely on doctors or public funding is not a viable option at the current time, and nor is it likely to be so in the foreseeable future.


Dr Reinhard Griebenow, chair of European Board of Accreditation in Cardiology and Dr Jeffrey Tabas (University of California, San Francisco School of Medicine) advocate the idea to keep industry funding as independent as possible by defining more precisely what “unrestricted grant” really means. Drug and device makers would give academic institutions or societies a grant for "projects," and the society could then decide what topic to use it for. "That would be truly unrestricted, and a big step forward."

Hospital adoption of HIT is accelerating in the USA

January 31st, 2012 - (ESC Board) -Healthcare and Information Technology


The Optum Institute commissioned Harris Interactive to conduct a survey of 301 U.S. hospital CIOs to explore overall progress in digitizing medical care, current health information technology (HIT) capabilities, plans for HIT expansion, stage of “meaningful use” progress, value of interoperability, and benefits and challenges associated with technology use. The survey (Health Information Technology: Hospital CIOs) was conducted online by Harris Interactive between December 2011 and January 2012.


Hospitals making impressive strides with electronic medical records (EMRs)


Nearly nine out of 10 hospitals surveyed (87 percent) now have EMR systems in place – up significantly since 2011, when the Health Information and Management Systems Society (HIMSS) reported that only slightly more than half of CIOs had a fully operational electronic health record in at least one facility in their organization. Seventy percent of CIOs report their systems have attested to meaningful use 1 criteria (MU1) and 75 percent anticipated being able to meet expected meaningful use 2 (MU2) criteria by 2014.


“Hospitals are making substantial gains in adopting electronic medical records, participating in health information exchanges, and achieving ‘meaningful use,’” said Simon Stevens, chairman of the Optum Institute. “But hospital chief information officers are clearly signaling that technology gaps remain, genuine interoperability remains elusive, and – as a result – most U.S. hospitals are still some way off from being fully ready to play their part in managing population health and its related financial risk.”


Key barriers remain:

The survey identified six main technology concerns facing hospital CIOs:

Technology-related spending continues to rise: CIOs are making new investments to modify their systems, link with other systems, purchase upgrades, or buy entirely new systems. Nearly 80 percent of respondents said they had to modify their system significantly in some way or purchase another system entirely. For those that have implemented EMR and HIE systems, hospital CIOs report that new capabilities have so far raised hospital costs, not reduced them.


Gaps in key care information: Almost two-thirds of hospitals said they own their own health information exchange (HIE), but key care information, including hospital discharge information, computerized prescriptions, physician clinical notes, and lists of patient allergies and medications, is available only about half the time.


Interoperability among the major concerns: Among those participating in an HIE, data is on average accessible for only 60 percent of patients through the HIE. Two-thirds of respondents found data accuracy/completeness to represent the biggest business and technical issue they faced in using HIE capabilities, followed by inaccessible proprietary systems and high costs of interoperability.


Compliance barriers: For those that have an EMR system, the largest barriers to complying with meaningful use requirements include cost (57 percent), sufficient time (55 percent), and legacy system incompatibility (34 percent).


Extending systems to the cloud: Recognizing the benefits of cloud computing, 59 percent of those who have an HIE/EMR system plan to invest in cloud-based open systems.


Reform readiness: Hospital CIOs report being more prepared to assume broader responsibility in managing patient care than financial risk. Still, only one in four CIOs report that hospitals in their community are extremely/very prepared for increased responsibilities from managing patient.

A sunshine act "à la française "

January 1st, 2012 - (IFPMA) - Healthcare Regulatory update


The new article L 1453-1 of the French Public Health Code requires a general disclosure obligation on any company manufacturing or commercializing products with a medical or cosmetic purpose. The obligation concerns all agreements such companies may have with healthcare professionals, students of medicine and other healthcare related studies, clinics and hospitals, foundations, press and communication agencies/companies, software editors of drug prescription related softwares, as well as with educational companies in the healthcare area.


The obligation will require disclosure of any advantages in kind or in payment provided by the companies to such persons mentioned above (the threshold amount triggering this disclosure obligation is to be determined by decree).


The law provides for fines for infringing the obligation of up to 45,000 Euros in respect of physical persons and up to 225,000 Euros in respect of legal persons.


In addition, the law requires the disclosure by those holding regulatory powers devolved to them by the French Ministry of Health, cabinet members and members of the new ANSM of any conflicts of interests when taking on their functions.


Enforcement decrees will precise obligations.


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