Life Sciences Information Technology (LSIT)
Developing Good Informatics Practices (GIP) to Assure Quality Driven IT Governance
In recent years, the integration of information technology (IT) into life sciences and healthcare has progressed rapidly, and the potential consequences are profound. The effective and appropriate use of IT offers the possibility to reduce both the time and cost of bringing new medical therapeutics and products from discovery to the patient. The life sciences industry is the most regulated industry in the world. Paramount to adoption of information technology in the life sciences community is trust. It is critical for all stakeholders and gatekeepers to trust that very complex IT tools, computational processes, and resulting data are accurate and valid. On a global scale, trust is carried one step further, because it has the potential to be a common thread in rapidly advancing healthcare systems around the world.
IT engineering is not a core competency of medical researchers, the life sciences industry, healthcare providers, or the various governmental regulatory agencies. Yet these same groups are attempting to utilize very advanced IT systems to perform increasingly complex computational and data-management tasks, all in an effort to explore diseases at a cellular level, to develop therapies, and to utilize these therapies to treat and cure diseases affecting humans worldwide. Sophisticated, trusted, and reliable IT solutions are required to aid and accelerate this work.
HIMSS is investing in the life sciences community. The formation of the HIMSS Life Sciences Information Technology (LSIT) Committee is chartered with one purpose: To develop open, publicly available Good Informatics Practices (GIP) for the life sciences and healthcare community. This is an opportunity to contribute to fill the gap in the spectrum of medical product development from: discovery, research, development, and manufacturing, to provider and ultimately to the patient. HIMSS will contribute by addressing the information communications and technologies (ICT) that are the common denominator to linking and interconnecting the spectrum.
In this spectrum we include and define the life sciences industry to be pharmaceuticals, biotechnology, medical devices, and diagnostics. Within this spectrum there are periphery and interconnected areas within the life sciences to healthcare spectrum, such as, contract research organizations (CRO), clinical research, preclinical safety testing laboratories, as well as, radiology, pathology, histology and diagnostic laboratories.
The Convergence of Information Communications Technology (ICT) is the link to life sciences with healthcare that will inevitably include discovery and research & development as life sciences companies are sharing their preclinical safety testing and clinical data to work with providers worldwide.
It’s all about the data to information to knowledge. Most of us understand the link with providers in the world of clinical trials. A clear and straight line of data, information and knowledge that goes from the medical product (life sciences company), CRO’s to the patient (study subject), provider (Investigator), to where an application is eventually submitted for the new medical product to be accepted by the FDA, and other public health regulatory bodies and go onto the healthcare market.
ICT is the link. Every department of an organization uses ICT, it’s ubiquitous. This means ICT Governance bar has been raised in addressing and documenting anything from infrastructure to audit-ability of a computational system. Corporate ICT Governance becomes more important as we face HIPAA Title II and the enormous efforts of Interoperability and health information exchange (HIE) throughout the United States and abroad.
The challenge.
Life sciences are considered to be the most highly regulated industry in the world. In the United States the Food and Drug Administration (US-FDA) who is considered, by many to be the “gold standard” for protecting the public health and safety by regulating the Foods, Cosmetics and Medical product we use as consumers of healthcare. The US Food and Drug Administration, is an agency under the Department of Health and Human Services (HHS). Additionally there are many other nations that have an equivalent of the US-FDA whose goal is also to protect the public by assuring medical products are safe and effective.
The challenge is to comply, follow and adhere to the US-Code of Federal Regulations, HIPAA and many other multinational Laws, Regulatory and Standards bodies that apply to life sciences/medical products.
The goal is to leverage standards and guidances to help industry influence faster, better and more strongly constructed ICT that fills the growing demand for data, information and knowledge management.
The opportunity.
As Governments plays an increasingly key role in what medical products get on the market, we find it important and vital to have dynamic, ongoing Life Sciences Roundtable and LSIT Committee groups that support the industry for an expanding information based future.
The Goal of the Life Sciences Roundtable:
The LS Roundtable (LSR) is to engage leaders from both the Life Sciences Community and Healthcare ICT sectors in candid cross-industry dialogue, better integrating the activities and direction of each, and driving the transformation of healthcare through ICT.
The Goal of the Life Sciences Information Technology (LSIT) Committee:
The LSIT Committee is to advance the best use of information and management systems for the betterment of healthcare by providing global leadership for the optimal use of information technology and management systems. Its first priority is to develop the Good Informatics Practices (GIP) Guidance document that will provide much needed and desired guidance of ICT utilized within the regulated life and health sciences communities.
The Goal of Good Informatics Practices (GIP):
The Good Informatics Practices (GIP) Guidance is to provide best practices, assure compliance, reference and leverage standards, and share tools & artifacts in a prescriptive way to help an ICT professional be more effective, compliant and successful.
