Informed, data-driven decision-making is crucial for delivering quality healthcare and efficiency. However, data in a health facility is often scattered across multiple sites and may not be available as and when needed by clinicians. For example, many have different departmental systems, such as the Radiology Information System (RIS), Picture Archive and Communication System (PACS), Cardiovascular Information System (CVIS), Laboratory Information System (LIS) etc..Data in such systems is dispersed and often inaccessible, due to the presence of multiple IT silos. However, to permit the best use of healthcare resources and deliver the highest quality of care, all of them will need to interact mutually, and do so with the electronic medical record, too. This remains a major challenge. Healthcare data remains fragmented and heterogeneous. Given the sheer volume of imaging data in a hospital, enterprise imaging is being seen as the way to begin address such challenges.

Historical advantages of radiology
Experts generally consider radiology to be one of the best-placed clinical specialities to drive the integration of healthcare data at an enterprise level.
Radiology has some historical advantages for this mission. It has been the early adopter as far as advances in imaging technology and workflow are concerned.
Secondly, most radiology facilities have long since been digital and standards-compliant via protocols such as DICOM (digital imaging and communications in medicine). Given that radiology data is a critical component of a patient’s medical file, RIS and PACS can be appropriate launch pads for reconciling patient information, synchronizing order data and exchanging diagnostic results.
Many radiologists see themselves at the forefront of enterprise imaging by driving the agenda at the hospital management level and engaging with other image producers in their facility.

Need to cope with new demands
However, several issues have to also be taken into consideration.
The current generation of department PACS, in terms of their core architecture and workflow components, dates to the mid-2000s. They had been designed for use by a single physician in the imaging department.  As a result, healthcare organizations now have multiple PACS systems. These aim to provide a common standard of care. As care benchmarks evolve, the PACS must cope with ever-new demands.
Given the presence of disparate systems across different departments, an enterprise imaging strategy seeks to harmonize medical imaging across an entire network or organization. Until recently, many healthcare facilities used a ‘forklift’ approach to implement an enterprise PACS design across all departments. However, its limits soon became apparent – especially in terms of lengthy implementation procedures, mission creep and change management, as well as price. Most experts now propose an architectural design which accounts for multi-vendor integration. This is not only cost-effective but also minimizes the impact of radical change management across multiple sites.

Vendor neutral archives
In recent years, vendor neutral archive (VNA) technology has emerged to address challenges posed by proprietary systems.  VNA refers to an enterprise data storage and workflow solution. Its goal is to manage and share out large flows of information and address workflow challenges.
Data in a VNA is stored in non-proprietary formats, which permit open interchange. As a result, VNA permits sharing of DICOM and non-DICOM data.
VNA, coupled to the closely-related concept of Universal Viewer, allows healthcare facilities to store, distribute and view any electronically stored images without restrictions.

IHE frameworks
Making such developments even more pertinent is the availability of best practices- and standards-based frameworks from the Integrated Healthcare Enterprise (IHE) – which draws heavily on existing best-practices and processes – for example, the very specific needs of a cardiology or orthopedic department, or the time-critical processes at an emergency department (ED). 
IHE frameworks merge customization with a standards-based approach, to allow for rapid integration of systems and sub-systems and accelerate the adoption of information sharing across what were previously silos.
By avoiding information duplication and workflow disruption, IHE also achieves its goals without extra overhead and cost.  Indeed, one of the biggest barriers to system integration has consisted of disruption to an established care workflow.
On the other side, the integration of imaging workflow, from ordering through acquisition to reporting and billing, is considered to be a key factor to ensure that those viewing an image remotely are fully cognizant of both its context and presentation.

PACS 3.0
Next-generation PACS systems (or PACS 3.0) are likely to incorporate enterprise workflow/worklist applications, based on VNA, according to a noted US imaging technology expert, Michael Gray.
Plug-ins to the VNA, in Mr. Gray’s view, will feature diagnostic display applications used by different imaging departments, whether or not the images are in DICOM. Non-DICOM applications would deploy a front-end application to create the study from individual images and associate the proper patient and study metadata to the study.
In PACS 3.0, individual physician worklists present a list of specific studies to be consulted, while the underlying workflow launches the most appropriate display application, based on a physician’s pre-defined choices and the study selected from the list. In effect, the enterprise workflow/worklist application becomes the shared entry point for all interpreting physicians in every imaging department while the VNA is the data repository.

Beyond radiology
Enterprise imaging is nevertheless targeted well beyond the requirements of the radiology department alone.  A large (and increasing) number of images are generated and interpreted in other departments – for example, from an orthopedic procedure.
There also are certain kinds of images which are not formally considered imaging studies, for example during a dermatology consultation or during the course of wound care treatment. This kind of data is, however, becoming of clinical significance in areas such as personalized medicine, where it is an important part of the medical record of a patient.
Such images need to be shared, sometimes immediately. For example, pre-surgical imaging of a complicated ankle fracture in the emergency department could require transmission to not only an orthopedic surgeon but also of a vascular surgeon – with regard to blood flow in the poorly-vascularized talus. In such a case, instant access to previous images of ankle fractures would clearly enable an emergency department to best interpret new images.
Such circumstances are also apparent in the case of patients who present at different providers, since a second provider is at a disadvantage without access to earlier images.

Enterprise imaging and patient care
Acquiring data from a range of systems in different departments demands a buy from the top echelons of management and a commitment by all concerned members of the healthcare facility.
One argument for such alignment is the role of physicians – to provide the best-available patient care. Good enterprise imaging ensures that this is made possible by providing physicians with the most efficient tools and resources.
Indeed, it is not rare for the patient experience to get lost in the context of technology paradigm shifts or major process overhauls such as enterprise image/data integration. To avoid this and ensure maximum effectiveness, healthcare organization need to closely focus on both the individual patient as well as the complete continuum of care.

From EMRs to image lifecycle management
Drivers of enterprise imaging also come from the side of the electronic medical record. Hospitals have been seeking to stretch the frontiers of the latter by enhancing communication of both data as well as images.  Enterprise platforms, once looked at as no more than a storage medium, are now being geared up to give a comprehensive view of a patient’s medical history.
One challenge here is the rapid growth in the volume of imaging data. This is compounded by fragmentation and an ad-hoc approach to image management.  As storage requirements have grown, data has also become more distributed in terms of multi-site PACS as well as storage tiers, based on clinical urgency or relevance as well as legal and regulatory requirements.
Benefits from enterprise imaging solutions aim at better control of the lifecycle of a medical image – not least by providing better control over storage capacities and aligning storage costs with operational priorities.
Hospital managers who are renewing or upgrading to a newer PACS system usually seek some degree of future proofing, in the form of scalable solutions and methods to manage a growing corpus of images, many of which are dated. Identifying older images which can be compressed or deleted saves on storage space.

The Enterprise Imaging Program at Cleveland Clinic
The prestigious Cleveland Clinic in Ohio provides a good definition of enterprise imaging strategy as means to address the overarching need “for standardization of clinical image acquisition, management, storage and access.”
The Cleveland Clinic enterprise imaging program incorporates all producers into its clinical image library, which is connected to electronic medical records. In total, this includes images from 11 different healthcare service lines, in addition to radiology images. By the end of 2016, according to one report, 440 different image-generating devices residing outside the radiology service had been integrated.

Commercial solutions
Today’s marketplace already offers a range of enterprise imaging solutions for healthcare enterprises.
Typical examples include diagnostic-quality images provided to clinicians on demand, as well as interfaces with third-party applications to enhance programmes. Some focus on providing a comprehensive view of the healthcare workflow. Others improve image routing and support telemedicine services.

Emergence of artificial intelligence
One of the latest additions in the enterprise imaging arsenal is artificial intelligence (AI).
In recent years, as radiologists have been forced to cope with the explosion in medical imaging procedures and storage capacity, AI seems to be showing early promise. AI is also being used to directly help the care delivery process.
Some medical technology vendors have showcased AI applications integrated with their enterprise imaging platforms. These typically consist of imaging analytics software that assists radiologists diagnose diseases before symptoms occur, and more accurately interpret findings. For example, machine vision AI algorithms pinpoint anomalies within images in real time, alerting radiologists to incidental findings. Physicians could then screen patients further for what may still be asymptomatic conditions – but could develop into a major disease.

No one doubts that radiologists will work increasingly in the future with AI, both to improve the technology itself and to reduce routine, repetitive tasks such as confirming line placements and looking at scans to find nodules.  On its part, AI is also likely to become increasingly smarter, to improve efficiency, for example by prioritizing cases, putting thresholds on data acquisition, improving workflow by escalating cases with critical findings to the worklist of a radiologist and providing automatic alerts to both radiologists and other concerned clinicians. Such steps would not only free up resources for additional testing but also improve patient care, thereby making radiologists even more integral in the care management process. These perspectives are of course central to a robust enterprise imaging strategy.

Two studies on information technology and patient safety were released in the US in April 2018.
The first, by ECRI Institute and its Partnership for Health IT Patient Safety stakeholder collaborative, takes a searching look at the hidden risks of healthcare IT (information technology) systems.
The second report, by Pew Charitable Trusts, focuses on electronic health records (EHRs), and is based on its long-standing view that in spite of more than 30 billion dollars (£25 billion) of federal health IT investment over the past decade, the transition from paper to electronic records has yet to reach its potential to enhance healthcare coordination and improve patient safety.
Both studies call for a much greater degree of proactivity to anticipate problems before they run out of control. Interestingly, there also seem to be several parallels in their respective analyses of the challenges.

A broad-based look at patient safety
One of the first priorities for healthcare organizations is to tie health IT into existing patient safety initiatives. The challenges that exist whenever older systems are updated or replaced, or integrated with successor technologies, can ideally become learning opportunities. However, this requires the organization to have a collaborative management culture that makes initiatives such as IT safety and other best practices part of their daily workflow.
Both the ECRI and Pew are emphatic about the need for collaboration. ECRI lays down specific recommendations on obtaining feedback from stakeholders (patients, payers, cybersecurity experts, regulators, providers and others). The Pew report also maintains that collaboratively gathering inputs from across the healthcare stakeholder spectrum is critical to improve patient care and reduce provider burden in the context of EHR use.

Tip of the iceberg
The ECRI Safe Practice Recommendations begin with an ominous warning – that the known universe of IT-related safety problems are likely to be just the tip of the proverbial iceberg. The net risk from such issues is that a variety of bugs are lurking beneath the surface, and, in the ECRI’s view, pose permanent dangers to patients. Such risks, in turn, are compounded by the sharp growth in recent years of ransomware and other cybersecurity threats which seek to exploit loopholes in codes. For ECRI, this is a key reason why both providers and vendors need to make health IT safety an integral part of their overall patient safety program.

The ‘over’-customization quandary
In general, the roots of healthcare IT problems stretch back to the 1980s and 1990s when demands for customization led to ad-hoc rewriting of legacy programs, so as to avoid loss of functionalities. So-called patches, as part of platform updates, also sought to retain some of these functionalities, many of which had been proven – or otherwise become indispensable – over the years.  During this process, poor documentation of code changes was commonplace. In addition, since legacy systems faced many problems communicating with one another across their proverbial silos, layers of integrative middleware were added in sequence until they became cluttered and unmanageable.
Many such concerns are reflected by Pew. Over customization, auto-refresh mix-ups and unclear default settings with EHRs, as well as alert fatigue, can all result in patient harm.
An earlier Pew report in December 2017 had explained that safety problems could be caused by the very design of an EHR system (e.g. complex interfaces and guidance terminology) or by its customization during implementation and adaptation. Like the middleware in an IT system, Pew explains that an EHR “interface that is cluttered may cause confusion or an inability to locate key information, whereas an overly bare display may force the clinician to search for information in multiple places.”
Indeed, some of the reasons for risky over-customization of EHRs directly reflect those made during program rewrites to legacy IT systems in the 1980s and 1990s.
As the Pew study observes, healthcare facilities often work with vendors to customize certain aspects of their EHR system which fit their workflow, for example by displaying data which is critical for specific clinicians at a particular facility. However, it warns, such customizations “may not have undergone rigorous testing and could lead to unintended safety consequences.”

Specific risks with EHRs
The Pew report highlights a range of specific risks. One of the most commonplace may consist of mix-ups in auto-refresh of patient lists when EHRs revert to the default view. In such cases, providers can inadvertently make medical decisions based on another patient, rather than the one being treated, if they do not realize the system has just refreshed a particular list.
Default EHR settings are also seen as a specific danger for medication dosages. Healthcare providers may think they are ordering a fixed dose of a particular drug, while what they enter instead “is multiplied by the patient’s weight, potentially contributing to overdoses,” Pew notes.
Yet another problem consists of incomplete laboratory results, which can result in erroneous medical decisions since a provider lacks complete information on a particular patient. In effect, physicians may fail to realize that not all lab results are displayed on a screen, or that results may have been delayed – among other reasons, because samples might still be undergoing testing.

In its recommendation to integrate health IT safety into a broader safety program, the ECRI report also pointed explicitly to the rise in duplicate medication errors after a new EHR implementation. Contributing factors include the design of the EHR as well as the occurrence of task-related changes (such as multiple persons entering orders for the same patient at the same time).
Other EHR-related problems mentioned as cases by ECRI included data entry of a pediatric patient’s weight in pounds rather than kilograms – followed by erroneous medication dose, incorrect alert responses due to the simultaneous opening of multiple patient charts, the inability to account for problems such as a pending swallow evaluation before a dietary order, or an allergy to eggs which contraindicate propofol.
Some of the most frequent EHR problems concerned mix-ups of patients, in one instance due to two having the same name !

New safety approaches: collaboration and workflow integration
Beyond EHRs, as the hitherto-unknown problems in the health IT iceberg become more apparent with time, users are advised by the ECRI to collaborate in order to integrate and embed new safety practices into their daily workflow. Suggestions include the provision of inc entives for actively working together on safety-related efforts, and to learn and share analysis of near-misses and other hazards, as well as workaround strategies.

Pew too had stressed the importance of collaboration for improved EHR use, in its December 2017 report.  One way towards this is to bring stakeholders together to share data on patient safety incidents and do this in a “nonpunitive environment.” After this, stakeholders can be encouraged to “develop solutions for common and significant usability issues.”
Pew also suggests that safety tests on functionality and usability are conducted by entities throughout the entire EHR life-cycle – from development and after implementation. Such a process should bring together developers, IT professionals, clinicians, nurses and pharmacists – in essence, every one using the EHR system.
Pew cautions that one specific area for attention is alert fatigue (due to too many unnecessary or false alerts). This can result in genuine life-saving warnings being missed. One concrete means to avoid such conundrums is by designing EHR systems to specifically verify and red flag certain potential problems (e.g. dangerous drug interactions with different medications).

The need for encouraging a collaborative culture to enhance healthcare IT safety has also been identified in Europe. In 2015, a team led by Solvejg Kristensen at Denmark’s Aalborg University studied the association of quality management systems with teamwork and safety from seven European countries. Although they found different approaches to quality management systems and to perceptions of teamwork and safety climate, they noted the importance of organizations investing in leadership, time, capital and technical expertise to attain continuous quality improvement and enhance patient safety.
Indeed, at whichever facet of the healthcare technology spectrum one looks at, proactive, meaningfully structured collaboration may be the only way to achieve a unified vision of safe health IT and a wider culture of safety in the health enterprise.
As healthcare IT becomes increasingly pervasive, such concerns are bound to demand increasing attention.
The National Patient Safety Foundation and IHI
Many of these issues – in terms of both challenge and response – were the subject of a set of eight recommendations made in 2015 in a report from the National Patient Safety Foundation (NPSF) in the US to ensure “that technology is safe and optimized to improve patient safety”. The recommendations are as follows:

1. Ensure that leaders establish and sustain a safety culture
2. Create centralized and coordinated oversight of patient safety
3. Create a common set of safety metrics that reflect meaningful outcomes
4. Increase funding for research in patient safety and implementation science
5. Address safety across the entire care continuum
6. Support the healthcare workforce
7. Partner with patients and families for the safest care
8. Ensure that technology is safe and optimized to improve patient safety

European initiatives
In 2016, the NPSF added that it was also important  to make health IT-related patient safety an organizational priority by securing management commitment, and to develop an environment which was “conducive to  detecting, fixing and learning from system vulnerabilities.”
The NPSF was merged with the Institute for Healthcare Improvement (IHI) last year, and some of its initiatives are likely to be transferred to Europe via the IHI Health Improvement Alliance Europe (HIAE), which aims to improve work processes and create new delivery models relevant to European health systems. The HIAE has already established connections with professional societies in several countries, including Britain, Denmark and Belgium.
One good example of HIAE efforts is the The Platform for Continuous Improvement of Quality of Care and Patient Safety (PAQS), a Belgium-based initiative which aims to consolidate relationships between various stakeholders in healthcare in order to work together, in a consistent and cohesive manner.
Other facets of IHI which are expected to make a mark in Europe include the so-called Open School Online Courses. Several of these are directly concerned with IT-focused elements of patient safety and the need to build a culture of safety in a health organization.