Coming from a background of “LS vs HC”, I was over and over again impressed with how many HC companies are also interested in things like outcomes research, comparative effectiveness research and medical product development. There were strong feelings both for and against basic system interoperability and there were some noticeably missing players, however an air of possibility and optimism permeated the room (or was that the casino – forced oxygen) and i think, for the first time I can recall, people were generally excited about the fruit to come from all the hard work of converting to EMR / EHR.

As expected, medical devices made a strong showing at HIMSS. Pharma and Biotech were largely absent, however a stronger presence was felt this year than in years past according to some attendees and organizers. HIMSS has done a good job of integrating the Life Sciences mission into their marketing materials and conference curriculum as well as the entire topic of “Secondary use of Health Data”. Those sessions were well attended and were to me another positive sign of the LS – HC divide closing.

Speaking from a career built battling the feedback loop between medical product development and the delivery of health care, I am impressed now more than ever that efficient secondary use of the primary health record is becoming a reality. Now comes the question of what we do with that capability and how we actually improve lives, save money and ultimately make us all well.

-Ford Winslow

CIO, Abnology

Ford Winslow had the opportunity to present the Surgeon General, Regina Benjamin at HIMSS12 for the Interoperability Showcase with GE, Allscripts and Nextrials for Integrated Reporting for Clinical Research Participation and Drug Safety.

Symposium Schedule::

Advancements in information technology, including the proliferation of EHRs, are bridging the gap between the health care research and delivery settings while simultaneously creating an abundance of rich data. This symposium will explore the secondary use of data for business and clinical intelligence from the perspectives of the health care delivery systems, the life sciences industry, and comparative effectiveness research to deliver better, more personalized care to the patient. Legal, governance, and methodology issues around the data will also be explored.

Primary Goal:
To demonstrate a collaborative workflow process executed in a highly automated and secure manner between a Research Sponsor and  a Clinical Research Site where patient data is maintained and gathered.

Key Points:
Using a host of IHE profiles – including RPE, RFD, CRD, and DSC, this demonstration illustrates how drug utilization and adverse reaction information are exchanged in relation to patients in standard care, or in the scope of a clinical trial. This information is then used to expediently trigger action by the Food and Drug Administration (FDA) or the drug manufacturer to support drug safety in the industry.

Meaningful Use Relevance (MU Objectives):
Improving population and public health

Clinical Workflow:
A clinical research site such as a hospital or doctor’s office collects the protocol definition from the clinical research sponsor. Patient history and information are pre-populated into a clinical research form.  Clinical decision support is used for the alert portion of the use case. The information so gathered is authenticated at the trial site before being forwarded to the sponsor and archived in the site clinical trial document vault as part of the permanent source record of the trial. A drug safety form provided by the clinical research support entity is also completed and forwarded to the sponsor. The clinical research support entity that retains and managers the forms to be used for this (and other clinical trials) provides the forms to the hospital or doctor’s office to complete the form for its patients.  As the form manager, this entity also provides guidance and management of the administration of the form distribution to both a form archiver resource and the research sponsor. Independent form management allows for variation in data entry of required elements and verification of submission from within the EHR. The research sponsor support entity archives the completed forms for the clinical trial. The research sponsor receives the completed clinical reports fro the PCP in accordance with the clinical trial protocol.

Trust is hard to earn. It’s even harder to verify.
Many companies say you can trust their IT systems and cloud solutions. But can you demonstrate HIPAA and health care compliance? Our Trusted Health Cloud is powered by our Abnology IT Quality System enabling you to trust and leverage the benefits of cloud computing while demonstrating compliance.

Compliance and governance at the core.
For us, compliance isn’t an event; it’s a process. We blend compliance into our integrated solutions. Our platforms are built upon the abnology IT Quality System allowing us to seamlessly integrate your requirements for Governance, Risk and Compliance out- comes into our integrated solutions. Our Trusted Health Cloud enables providers to share information in the rapidly advancing health care systems in the United States and globally.

Interoperability drives innovation. We make it happen.
When organizations have different security requirements and access to specific information, it makes it even more difficult to share health information across different platforms. Our Trusted Health Cloud achieves the balance between sharing information, security, and compliance to make interoperability possible in the clinic.

Demystifying the cloud.
Abnology has extensive experience delivering integrated solutions for our clients. Abnology abstracts technology so you can focus on delivering successful health outcomes for your patients.

Connectathon Overview

The IHE Connectathon is the healthcare IT industry’s only large-scale interoperability testing event. Connectathons are held annually in Asia, Europe and North America. During the Connectathon systems exchange information with complementary systems from multiple vendors, performing all of the transactions required for the roles they have selected, called IHE Actors, in support of defined clinical use cases, called IHE Profiles. Thousands of vendor-to-vendor connections have been tested overall, and tens of thousands of transactions passed among the systems tested. The sponsoring organizations publish the results of this testing for public review (see below).

The Connectathon provides detailed validation of the participants’ interoperability and compliance with IHE profiles. Participating companies prepare for the event using testing software—the MESA test tools—developed for this purpose. It offers vendors a unique opportunity for connectivity testing—removing barriers to integration that would otherwise have to be dealt with on site, at the customer’s expense. Companies taking part have responded overwhelmingly that the IHE process addresses important issues in their product development plans.

Organizations interested in participating in future Connectathons are encouraged to refer to the Connectathon Fact Sheet that describes the process and timeline for the Connectathon.

IHE maintains a database of results from IHE-Europe and IHE-North America Connectathons.

Developers of health information systems are invited to take part in the HIT industry’s largest interoperability testing event. First held in 1999, the annual event has grown to include more than 150 systems from over 100 participating organizations and more than 3500 successful tests of IHE Integration Profiles were performed and verified. In addition to nearly 500 systems engineers engaged in testing at the event, more than 100 attendees took part in a conference featuring prominent speakers on health IT and electronic health records.

IHE North America Connectathon 2012

January 9-13
Hyatt Regency, Chicago

Where:
Fish & Richardson
12390 El Camino Real
Third Floor Conference Room
San Diego, CA 92130

Driving Directions

Our Mission: to facilitate collaborations to develop GIP Guidelines for the life sciences and healthcare communities and a common risk based IT framework.
Our Vision: to become the trusted reference body driving global adoption of GIP Guidance to assure optimal worldwide IT quality and trustworthy systems.
Our Tagline: Developing Good Informatics Practices to Improve World Health.

The Committee will strive to uphold these value principles for GIP:

• Best Suited IT Practices & Established IT Standards
• Prospective Designed & Engineered IT Quality Systems
• Incorporating Health & Life Sciences IT Standards
• Full Governance and Regulatory Consideration
• Risk Based Assessed GIP Framework
• Establishes IT GIP Boundaries and Ceiling
• Guides the IT Specifications Requirements
• Guides the Standard Operating Procedures Requirements
• Guides the Verification and Validation Process
• GIP Guideline Adoption Yields
• Strong ROI and IT Simplification

Task Force Members:

• Infrastructure Chair — Ford Winslow

“The Cloud” is one of the most heavily buzzed concepts in IT today. Please join us for a panel presentation with local Technology and Life Science Industry insiders about how to get past the buzz and extract value from Cloud environments and deployments.

• Learn about successful strategies for leveraging Cloud resources for regulated business functions and validated systems.
• Get a better understanding of the myriad of considerations when selecting, planning, implementing and maintaining a distributed regulated system.
• Gain knowledge of the business, technical and regulatory challenges facing organizations in their migration to the Cloud.
• Have your questions answered by the team of experts assembled.

This 2-hour session can help jump-start your move to the Cloud.
Please join us on March 24.

“In today’s economy, IT departments, are facing more pressure than ever to do more with less while meeting increasingly strict compliance standards. Cloud computational resources promise amazing economies of scale and flexibility, with the ability to adapt to dramatically increasing computational needs.  The key is making sure the Cloud can function with the confidentiality, integrity, and availability which regulators require.”

Ford Winslow
LSIT Board of Directors
Chair (Interim), LSIT Industry Advisory Board
CIO & Co-Founder, Abnology

Discussion Topics:

• Extracting value from the buzz
• Technical challenges migrating to the Cloud
• Regulatory challenges migrating to the Cloud
• Planning, implementing and maintaining regulated business functions in the Cloud

http://www.americanis.net/life-sciences/index.php