Standardisation in medical industry

Imagine yourself sitting in a remote village in Northern Iceland, sipping a hot cup of Cappuccino and watching Aurora Borealis. Appreciating the beauty, you click an image and send it to your friends. The waiter brings in the check which you pay through your credit card issued in your home country. How does this all work? There is a standard set of protocols which is followed by the telecom and the finance industry worldwide which makes this information exchange happen. These industries are highly regulated as also matured from standards perspective.

Standards are found in practically every area of our daily lives, but why do we need them in healthcare information technology (health IT)?  Today’s current healthcare sector landscape consists of a variety of care settings and stakeholders, which all leverage a number of different information systems in their delivery of care. An individual will touch a number of disparate systems that must be able to communicate throughout his or her health journey so as to help efficient and effective treatment options.

In case this individual is hospitalized, multiple systems from multiple vendors may be utilized: For example, laboratory, pharmacy, electronic health records (EHRs) and critical care, yet each of these systems must be able to seamlessly share data to provide information needed to dispense care for this individual.

After leaving the hospital, the individual likely has other providers involved in the coordination of their care, who exist outside of the hospital’s health system. These physicians may also have different systems within their practices, but still need to access health information on their patient to obtain a more complete picture of their patient’s health.

This individual might want to receive a care summary or test results to maintain for their own personal records. As the electronic exchange of health information becomes ubiquitous, the individual, or the consumer, is becoming an increasingly active stakeholder in this ecosystem.

In healthcare sector, standards provide a common language and set of expectations that enable interoperability between these systems and/or devices. Ideally, data exchange schema and standards should permit data to be shared between clinician, lab, hospital, pharmacy, and patient regardless of application or vendor in order to seamlessly digest information about an individual and improve the overall coordination and delivery of healthcare.

Challenges
We have witnessed a number of standardisation initiatives globally over the last two decades. In some fields and select parts of the world, we have seen active adoption and deployment of standards.  Others are in a catch-up mode. We are still saddled with the challenge that most healthcare information systems cannot exchange information between them. Either the standards are not completely implemented, or national implementation guidelines simply do not exist.  These causes unacceptable risk to patients, inefficient use of healthcare resources and sub-optimal development of medical knowledge.

The reasons attributed to the lack of standardisation are:

• complex nature of healthcare, the different agencies that come together to dispense the same,
• variations in information exchange requirements that exist within different specialities, countries and organisations,
• diverse requirements and rapidly changing technologies,
• different clinical pathways, practices and protocols that are followed by practitioners and organisations
• new software tools
• standards and procedures from a large number of affiliated non-health organisations,
• Innate resistance to change within a large installed base of different systems owned and operated by different organisations in the network of collaborating healthcare entities

Benefits of standardisation
In cases where standards have been implemented, we have observed radical improvements in the areas of

• A holistic approach to treatment leading to positive patient outcomes in terms of reduction in complication rates, morbidity, mortality, length of stay and costs leading to positive patient experiences
• Clinical care pathways, evidence based medicine and CPOE
• Standardised procedures and consistency in care dispensation
• Consistency around patient privacy and security
• Integrated ability to manage data and run analytics and clinical decision support systems
• Low cost, high quality service provisions
• Lean management structures favouring controlled outsourcing
• Increased efficiency in biomedical supplies, support and maintenance
• Ability for a rapid scale up and hence growth and profitability

Current trends
There are quite some organisations globally engaged in driving standardisation across the healthcare industry. ISO Technical Committee (TC 215) is engaged in driving standardisation in the healthcare space. Eucomed is driving similar initiative among its European and other international members.  TC 215 has 24 participating and 21 observing countries including 9 working groups.  CEN (Comite Europeen de Normalisation) TC 251 is working on information exchange standards in health informatics with 29 member countries.  HL7 in the US is working on protocol standardisation for information exchange between devices. Then we have the DICOM standards committee engaged on standardisation of image formats. Japan Association of Healthcare Information systems is also committed to global standardisation efforts.  CONTINUA is another organisation driving standardisation among small devices.

The member organisations who drive the standardisation efforts would comprise representatives from healthcare regulators, International standardisation bodies, Global medical technology industry, Medical professional groups, Notified certification bodies and major Pharmacopoeia. As very well summarised by NEC Technical Journal Vol 3, issues of major concern in the field of medical care relates to its quality and safety aspects. Although standardisation alone is not sufficient for securing safety and quality, there is no doubt that it is a critical factor in their implementation. Collaboration with people in the clinical field as well as among healthcare industry, government and academia are more important than ever for promoting the dissemination of standardisation.