Health Care Technology as it Relates to Health Informatics

Technological advancement has been a development of the recent years.  The same can be defined as the craft, art, or skill involving the application of techniques in processes aimed at achieving given results through scientific investigation. These advancements have touched most areas of society.  However, there is more reliance towards social advancement as compared to those made in other areas. The area of healthcare and medicine; from manufacture to patient care has thus experienced the effects of this progress in the globe today. The paper will venture to explore the various particular aspects of healthcare technology and its ultimate relation to healthcare informatics.

Healthcare technology and informatics emerged as an area of interest after the sophistication of computer technology as a tool for manipulation and handling of data. According to present record and evidence of advancements, standardization of this field as an area of study took place in the 1960s.  Health Care Technology as it Relates to Health Informatics. The standards for healthcare data reporting were established by the American society for testing and materials in line with guidelines from the Healthcare Information and Management Systems Society (HIMSS). Some of the developments that were enshrined under this include those for laboratory message exchange, electronic health records system properties, data content and health information system security.

The first instance of incorporating technology systems is that of the electronic medical record. The same came into use soon after new nomenclature in the discipline took shape in the field of health care and subsequent popular use. Further developments led to specialization and development of related disciplines. For instance, ten years later in the 1970s, the area of bioinformatics came into place whereby biological data including DNA could be studied and analyzed. In the meantime, the other processes in the healthcare system including registration of patents, observation of orders, financial transactions, and even discharge took a technological surge too.

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Technology in heath information has consequently grown in line with requests and actions aimed at standardization of data and exchange of protocols. These advancements have grown to encompass other disciplines like radiology and pharmacy within the umbrella of healthcare. For instance, these developments have led to the development of related postgraduate courses in health care technology and informatics, especially at the master’s level. This kind of surge in the area of education is in response to the prevalent gap present in the field. The profession is in need of personnel to fill this gap. The incorporation of global standards has well led to the development of the area of health informatics into the development but already complex discipline that it is today. Health Care Technology as it Relates to Health Informatics.

Linkage between Operation Components and Quality Improvement Initiatives

The standard in place usually relates to the area of work processes and not the developed technology systems. As such, a notable trend is that of clinical professionals facing the challenge of achieving interoperability. This situation calls for a remedy in the form of structures in place to counter such a development. The aspect would be important in enabling information availability across all sectors in the healthcare enterprise. In the end, the involved professionals inevitably have to use integration of custom programming solutions in order to integrate dissimilar systems. As such, tremendous strides concerning knowledge and training are needed in order to improve the standards of technology and patient care.

The progress made in terms of technological advancement in the area of healthcare is not devoid of regulatory influence. Concerns have been voiced in regards to the government input on the issue. There is a growing amount of regulations and perceived hurdles on the progress in healthcare technology. As such, the number of health care tech devices that the developers would bring into that market seems to have been limited. However, as will be noted going forward, the government input has an important role to play through regulation measures. An instance of interest is the regulation introduced by the Centre for Medical Services (CMS) in 2014.

The legislation was instituted as an attempt to redesign the regulatory framework for technology types and lessen the control of CMS over this industry. The issue of whether these above named standards and actions are good or bad is still a topic of the debate thus. Most critics, while analyzing the effect of these regulations put in place sum up that the regulatory body though infringing using its mandate is still within the confines of statutory requirements. It is completely within its rights to place limits on medical technology.

The standards and regulations set out by CMS in association with AHIMA are meant to safeguard the welfare of the consumers. The same is done by ascertaining and correcting any disingenuous claims by the customer that are alarmingly high of recent times. The aspect of faulty manufacture or development and accepting the fault later is common in the manufacturing world. However, in the medical field, such a development or situation would be hazardous to the subjects due to the potential harm that it is bound to cause. As such, stringent mitigation measures are needed in place. Most often than not, the manufacturers are in a rush to beat the competition or take advantage of markets by the release of new products.  The same is done out of self-necessity and propagation as opposed to the need to satisfy the wants of the consumer while safeguarding their welfare too.Health Care Technology as it Relates to Health Informatics.  As such, regulations meant to slow down the manufacturers’ to maintain the safety of patients and other users at large are completely justified.

A common development that has been dominant is that of increased input of technology in health and wellness. For instance, app developers are intensifying on the same in the recent times. However, what we are not informed is the fact that these utilities are just generic and are of little input concerning real medical progress. They are thus what is termed generic applications and utilities. The same are not cleared and given green light by AHIMA as medical devices.

These applications are dangerous since they would serve to mislead the consumer by providing fictitious calibrations. The above body has consequently emerged to be the premier provider of medical safety regulation in the world. The body, although lacking the necessary resources and infrastructure has still managed to regulate the massive number of generic software available under the precept of medical apps in the market. The lack of input from the app manufacturers in the area of regulation means that the process remains to be burdensome.

There are a number of measures that can and have been instituted by the tech manufacturers and regulatory agencies like one above named aimed at improving tech regulation and the overall approval process. A main move towards the same requires a strict adherence to the set-out precepts of standards and regulations. For instance, in the process of manufacture, the medical companies need to be in adherence to AHIMA’s safety regulations. These guidelines offer a general control in the area of medical devices. Its provisions specifically relate to cases of adulteration or alteration, misbranding, registration of devices, notification of the market before release, repair or replacement, banned and restricted devices, and ultimately the provisions on good manufacturing practice.

In addition to the above stipulation, the office of civil rights needs to verify that medical technology manufacturers hold to the set out guidelines that denote a company as either good or bad in terms of practice. The process of review and approval of new utilities needs to match the prevalent level of technological advancement. A program for acceleration and review is thus needed in place to help the health care professionals keep pace as noted above. Most of these utilities are put to use in regards to preventive medical care. As such, they can only be of good use if they are present prior by the provision to the consumer quickly or rapidly.

On the other hand, CMS is vested with the role of ensuring that dangerous utilities are eliminated from circulation and consumer use. As such, the body makes it a priority to ensure that non-approved apps are eliminated from stores where they are available or labeled otherwise. For instance, a utility that is meant to be of medical importance but its specifications do not match can be relabeled into entertainment purpose instead. Such actions in classifications go a long way in safeguarding consumer welfare and safety from jeopardy.

The other main tenet that would and currently serves to holster technological progress in health care is that of research funding. The National Institute of Health and other vested organizations need to increase their input towards health care research. The increase would serve to provide proper leeway towards advancement in terms of newer and better utilities and further in terms of infrastructure development. An input of resources would aid to open up research and development aimed at proper standards, protocols and, in general, the ways in which work is done. Health Care Technology as it Relates to Health Informatics.

The aspect of general control discussed above in terms of regulatory measure instituted by AHIMA has a significant impact on an organization’s general and specific work processes. As earlier noted, technological, medical utilities are classified based on safety and effectiveness. Consequently, the basis puts these utilities into a number of classes on grounds of sufficient information that qualifies it to be classified as such. The body has instituted general controls and guidelines in place to guide this process.

General controls refer to the basic authorities provided by the regulatory body as the basic authority for the amendment on safety and effectiveness. These general controls cut across and apply on all the classes of medical utilities as grouped on the basis mentioned earlier. However, based on the hazard posed, there are some guidelines that specifically apply to the high-risk devices on the classification as further outlined.  Utilities grouped under Class 1 are not intended for use in sustaining or supporting life. They are further not of importance in terms of preventing impairment to human life specifically because they may not. Additionally, in the course of their use, the utilities should not pose unnecessary potential illness or injury.

The general provisions, controls, and controls as outlined in the act have been mentioned above. The provision that pertains to adulteration stipulates that a device should not introduce filthily, decomposed or putrid substance. Further, its preparation needs to be wholly devoid of unsanitary preparation, packaging, and handling conditions. An adulterated utility thus is that which is partly or wholly composed of poisonous or deleterious substances. For the purpose of coloring, it is composed of any additive that can be classified as unsafe. Ultimately, these factors mean that its safety, strength, and quality fall below what it claims to represent,

A misbranded medical utility has a label that is false or misleading. For instance, the package label may be missing some of the important information components that include the following. Details of the manufacturer or business that distributes it in terms of place, manufacturer, packer, and distributor. An accurate statement of content details in terms of amount, composition, measure, and count. Any words or statements that are explicitly required not clearly included or stated on the label in a way that can be explicitly read or understood also constitute the same breach. In cases where the product has associated health hazards, they should also be included in the description. Warnings as noted and directions of use among other necessary precautions are thus important aspects of interest too.

There are devices or utilities that explicitly require notification to warrant application or use. A number of tenets are used to determine this aspect. A device presenting unreasonable risk or potential harm to the public needs such a measure. Notification is important so as to eliminate the risk through the application of all the practical terms of set out provisions. Other cases similar to this may require repair or even replacement as may be deemed necessary. Health Care Technology as it Relates to Health Informatics.  Some utilities are further restricted in terms of their level of access or the use that they can be put into. Ultimately, the regulations provide for good manufacturing practice aimed at ensuring efficiency, quality, and safety.

Regulation and its Impact on Quality Improvement

The aspect of regulation and some of its stipulations in terms of user safety as outlined are important aspects in a medical organization set up. As a pharmaceutical firm, the set out principles need to be taken into regard in the course of developing new products. The same helps the organization to adhere to the guidelines on safety that are aimed at safeguarding the wellbeing of the users. Measures put in place by the pharmaceutical organization towards adherence are crucial in increasing efficiency, quality of services, and the overall reputation of the production organization. As such, an application of the same is an important and necessary measure in the course of production and output realized.

The area of regulation in the input of technology can be analyzed in terms of its resultant impact on quality improvement in the organization. The key aspect of interest in this case is the area of primary care with the patient as the main attention factor. A background study on this subject revealed that there are a number of factors that serve to determine the applicability and efficiency of technology systems in healthcare. The main determinant factor is that of culture with a strong commitment towards use of technology in quality improvement. The next important aspect is presence of strong technological tools that would work to support tracking and extraction of data.  Ultimately, the presence of a technologically strong team that is able to support these developments in terms of workflow processes is of importance too.

To facilitate the process of quality improvement into a reality, the above mentioned factor need to be cushioned with a number of additional factors. Financial incentives are needed so as to offset capital, training and staff costs related to the activities of quality improvement. In addition, this is added to transformation assistance provided to enable building of practical skills, processes and workflows. The practice facilitates coaching and access to best practices in the process.

A strong culture of practice with a commitment towards use of technology in quality improvement emanates from a strong leadership base. For instance, a lead medical practitioner who champions for accountability and group learning would go a long way towards enabling the achievement of quality improvement. A learning organization undertakes continuous and a work in progress type of improvement where steps are made beyond any particular project. Time and resources are dedicated towards health technology and ongoing quality improvement.

A crucial step too is the application of health technology tools that enable quality improvement. Practices that enable the measurement tracking and sharing of healthcare delivery and performance measure and monitor the refinements to clinical work processes.  The overall internal and external patient experience and coordination of care are affected while improving patient care outcomes. Such tools include measures to allow for structured data entry, collection, analysis and reporting. The tool helps in the provision of quality patient care while facilitating population-level assessment. Registries, decision support systems, and general hospital care given in a quality manner serve this similar function.Health Care Technology as it Relates to Health Informatics.

An effective health care system also requires the input of clinical and staff knowledge and skills. The personnel of a healthcare system need to contain high levels of skills and knowledge that requires to be regularly updated with the changes in technology. The same are crucial in the extraction and analysis of data on health technology that would be applied to institute quality improvement measures.

One such measure is that of ‘Plan to do act cycles’ and the redesign of workflows to include the changes made in the overall strategy of quality improvement. Further, the practice of processes and workflows consist of structured processes for measurement and reporting of practice and clinician level data, and further the provision of feedback on the same. An adaptation of daily practice activities meant to improve on the patient care experience through the input of findings from quality improvement.

An input of financial incentives is another key aspect towards quality improvement. Financial incentives help to offset costs of clinicians and other staff that is spent on activities like health technology discounts, infrastructural support, and additional payments from payers among other related sources. These include visits or hospitalizations shared with participatory primary care practices. Further, the process of transformation supports results in the realization through activities like data feedback and benchmarking. The same results in the provision of actionable information from the performance that can then be compared with external benchmarks nationally for instance in order to pinpoint further areas of improvement.

Facilitation and coaching can also be practiced through external organizations with the aim of helping to develop skills that are related to health technology and quality improvement. Tools and expertise can be provided for use in troubleshooting and possible elimination of barriers or challenges. Ultimately, additional elements of peer to peer mentoring in the name of expert consultation helps provide specific evidence-based knowledge that is specific for clinicians and staff outside the medical practice. Collaborative community learning helps to convey shared opportunities, and challenges and lessons learned according to the stipulations of best practice. Health Care Technology as it Relates to Health Informatics.

Regulation in a Pharmaceutical production

The major challenge in the implementation of technological advancements in healthcare is in the area of enforcing compliance. The reforms made are bound to affect every aspect of the organization’s set up in its course of producing medical utilities.  Operations need to be compliant to the set of codes for electronic transactions. Every system, interface and vendor application needs to be evaluated and adapted. Some of the areas of specific importance include an evaluation and development of adaptation for financial and operational reporting, quality and management practices. The same requires the input of qualified and experienced healthcare technology professionals.

The government, both state and federal is strictly implementing the use of assertive regulation to manage this area. The government, through AHIMA focuses on numerous improvements in the area of healthcare, a process that has been in summative referred to as healthcare reform. The same focuses on a broad area composed of the areas of delivery and consumption. They key driving force element for these developments is the aspect of technology. The same is not just from a single provider but in contrast out of a ubiquitous explosion in tech devices. The large spectrum of regulations that govern healthcare is sometimes overwhelming to the industry players.

Every single facet is overseen by a given regulation or another, sometimes more than one. This situation sometimes makes professional players feel that they spend more time complying than in performing other work processes. The nature of stringent regulation on healthcare emanates from the weighty concerns that are at stake. Some form of control and oversight is necessary for such critical situations. Health Care Technology as it Relates to Health Informatics. Even under the wake of its perceived underhand bureaucracy, most of the industry players would still appreciate that the stakes on the potential users are high enough to guarantee the measures instituted.

The path to the provision of a new drug is married with a myriad of hurdles under the precept of regulation. The cumbersome process starts with the pharmaceutical firm protecting the item through patents. The same also includes permission to carry out clinical testing with the AHIMA, the body that warrants provision of products as discussed above. The process of clinical testing culminates in the review of results by a panel of private scientists. After approval and receipt of a new drug approval, the pharmaceutical will then go ahead to make a production in adherence to the set of market restrictions. The process of production then would proceed to the act of supply to intended users.

In this course, the pharmaceutical firm needs to obtain a reservation in the ditribution pharmacist in order to sell widely. The same is obtained in the form of pharmacy benefits management approval that is used in the administration of reimbursement plans. In idealistic terms, the drug will be included in the standards of care that are under the stakes of private medical specialists’ society. Eventually still, all these steps do not guarantee the sale and distribution of the drug in outlets. The physicians need to prescribe the same to the patient before it can be dispensed by the pharmacists. They are also subject to a license of operation and compliance as issued from a range of regulatory bodies.

Questions arise as to where the roots of complexity in the regulation of healthcare technology emanates from. A number of theories are consequently raised, ranging from historical accidents, bureaucratic turf wars, and the ultimate purpose that it all works to serve. In spite of the complexities that have been experienced so far in the course of oversight in regards to complications and inefficiencies, there are benefits that have been realized from the process at large. Instead of hindering the progress of the industry the process of regulation, with all its flaws has served to nurture and support the overall enterprise. One of the aspects of consideration, for instance, is the boost in public confidence. Health Care Technology as it Relates to Health Informatics.

The process of licensing and accreditation of physicians through the requirements in health guidelines serve to boost the confidence of the public. Safety and efficacy of drugs are enshrined in the safety and efficacy of prescription guidelines of the named body’s process of approval.  The given programs have served to enhance the overall respect for major elements of the healthcare system and the expansion of markets for goods and services that they provide. The process of regulation also includes the input from major fund donors that have created a solid financial base for the key sectors and players in the industry. A view of the system in this manner helps to provide a perspective for the different stakeholders involved.

The major stakeholder in the area of healthcare is the government. Both the state and the federal government have a role that they play in the process of regulation and streamlining the healthcare technology industry. As discussed earlier on, the process of approval, production and circulation are monitored and conducted under the approval of the AHIMA, among other similar bodies. From the process of production. The government institutions are involved in licensing and registration of activities.

Further, the operation of industrial and medical staff involved in the process of research and production is subject to government monitor. The personnel is trained and accredited by state managed institutions and bodies. Ultimately, all the activities carried out the need to be in conformity with the confines of the law.  Moreover, the government should regularly be reviewing its laws to ensure that they are in line with environmental changes.

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Input of Key Stakeholders in the Process of Regulation

Primary health care services are provided to the patient on a one on one basis. As such, the patient and staff have a role to play in the handling of regulations. The code of ethics dictates the medical personnel to make prescriptions and medical procedures with a professional view. As such, the activities and procedures administered to the patient are in conformity to regulations as dictated by set out guidelines and the operational code of ethics. The patient, on the other hand, needs to be in conformity too. They are under restriction to take or use medication by obligation and according to set out guidelines. The manner of conduction too needs to be such that their life and those of others are not put in danger. As such, both parties are subjects to the set of regulations.

The pharmaceutical firm involved in manufacture of medical products is not left out on the same. As noted earlier, the process of manufacture starts with an act of approval from the vested bodies in the form of patents and licenses.Health Care Technology as it Relates to Health Informatics.  The process of manufacture thus cannot start without the acquisition and approval of the same. The process is further guided under the precincts of best practice. These items serve to guide conformity in formulation, sanitation, safety of users and workers and the final overall quality of the product. Aspects such as the formulation of components, packaging of the product, nature of the labels and the items in display here are of importance. Distribution further follows the codes of safety, with faulty products subject to recall, replacement, and similar measures.

There is an input that regulation has on health data and related records. The use of patient of health data is subject to aspects of privacy and professional handling. As such, regulation is important in providing restrictions and guidelines. The same help to stipulate the measures that need to be instituted to safeguard privacy. For instance, there are regulations that are in place to guide dissemination of personal data. Mostly, personal data cannot be transferred without the approval of the owner. Further, the process of obtaining personal information is subject to similar guidelines. The user for instance needs to be informed and consents to the process of obtaining the data. Further, the owner gives consent on the uses into which this information can be put into.

Regulation and its Role in Management of Healthcare Data

The advent of technological progress has led to the conversion of most health data records into digital manipulate form. The process of conversion from physical to electronic form requires the input of professional expertise in the same. The information needs to be maintained in its initial form during and after the conversion. Electronic nature of data further poses additional issues of interest. The aspect of privacy and access changes with the process of conversion. As such, the precepts of regulation serve to dictate the process of conversion and storage so as to safeguard the user and the items of interest according to legislation. Therefore, legislation is an important in ensuring the integrity of user data in either paper/physical or electronic form.

Healthcare has grown in line with technological advancement over the time. Rather than erode the integrity of the institution, technology has worked to safeguard the integrity of work processes and increase its overall efficiency. The input of technology into the healthcare field has impacted the area of data recording, storage and the overall work processes from production, distribution, administration and management of patients. As a result of these advancements, there have emerged new professions in line with the new needs that are a gap to be filled in the sector. In summary thus, technology in healthcare is the parent to the emergence and development of health informatics as a subject, field and profession. All these aspects are further subjects to the traditional tenets of regulation, in line with set out guidelines for staff, institutions, and work processes. Health Care Technology as it Relates to Health Informatics.

References

Kalra, D., Beale, T., Heard, S. (2005). The Open EHR Foundation. Studies in Health technology and Informatics. 115 pp 153-178.

Patton, G.A., Gardner, R.M. (1999). Medical Informatics Education: The University of Utah Experience. Journal of the American Medical Informatics Association

Sarkal, I.N. (2010). Biomedical Informatics and Translational Medicine. Journal of Translational Medicine. 8; 22. Health Care Technology as it Relates to Health Informatics.