Information Technology and Ethics/IT and Healthcare

Information Technology has had a great impact on the efficiency of information systems across virtually every industry. Through various decades it has transformed how businesses run, up to the point that today, most specialized labor is unimaginable without a computer to support it. Healthcare, is not an exception and every day there are greater incentives to bring both industries together.

The management of the information is something integrated in the clinical industry. Doctors and patients interact in a complex information matrix. The doctor can be seen as a manipulator of information in the sense that acquires, processes, stores, reviews and applies information in relation to the history and evolution of the patient and the realization of diagnostic and therapeutic responses. All that information could be used to establish population patterns for a certain disease and has to be stored and organized.

Due to these characteristics of medicine, the advantages of information technology are increasingly used in an environment characterized by an increase in the number and complexity of medical specialties, greater availability of computers, greater computer familiarity, the need to store and transmit a large amount of information and the socioeconomic pressure that demands greater efficiency in the management of resources. Information technology acts on the way in which the patient's data is collected and analyzed, on the communication with other colleagues or specialists and on the biomedical literature that is accessed for decision-making.

Reasons why Healthcare and IT merged

Healthcare is a current and historically important issue in the United States and around the world. Since the 1950s till now there has been a huge paradigmatic shift in how Healthcare works. Before the dawn of the internet and electronic systems, many patient records were handled in house with the doctor's offices and hospitals. The state would have to audit doctor offices to ensure that privacy and health codes were being met. This was a costly and inefficient way to keep track of everything. This problem was then alleviated by the introduction of information technology.

Some of the native inefficiencies in the healthcare industry were alleviated by information technology. The need to keep track of patient records was the biggest hurdle in the 1970s. However, once that hurdle was somewhat automated many more issues and inefficiencies start to reveal themselves. The need for mainframes, patient record keeping, insurance integration, and keeping track of data that is invaluable to the healthcare industry. In the 1970s many hospitals began storing their records on a shared mainframe. This then cut out the need to send or mail outpatient records. Over the next couple of decades, it became clear that there was a need for more complex systems, and many hospitals and health offices still didn't have any of these systems in place.

Some strong incentives emerged in the healthcare industry to start integrating Healthcare and IT solutions. The major reason for large scale integration was the need to standardize and integrate healthcare IT solutions. The main driver of this integration was the Health Insurance Portability and Accountability Act of 1996 (HIPAA). There are two main parts to this legislation: protection for people who lose their insurance due to losing their jobs and second is the part which affects the IT operations by ensuring the privacy and security of health records. It mandates that there should be a standardization for the health care information systems for data exchange and security standards for storing data. The security standards are the first federal safeguard for the patients’ health information. HIPAA also requires that there be an ID number for every entity involved with health care. This allows the government to track if you are entitled to certain services. These mandates created a well-structured foundation to keep track of who is on who’s policy. After the implementation of the omnibus rules, the business associates not only had to comply with HIPAA but, more important, could also potentially be held civilly and criminally liable in case of a privacy breach . With this addition of improved security for electronic medical records, enforced by HIPAA, electronic healthcare seemed more promising than ever. Even with this security measure, electronic healthcare only started booming years later due to an American financial crisis. Even though HIPAA was signed into effect back in 1996, it started becoming more prominent in 2009 after the Health Information Technology for Economic and Clinical Health Act (HITECH) was passed which led to the second big push for IT in healthcare.

The second biggest reason why IT and healthcare merged stemmed from the 2008/2009 financial crisis. The change came from new laws, buried in the major legislation that passed quickly in February 2009—the “Troubled Asset Relief Program” (TARP) . People expected legislation to address the financial crisis, but instead, it addressed IT and Healthcare. In order to maintain their existing level of Medicare and Medicaid payments, all U.S. physicians were required, by 2014, to use electronic medical records and to send electronically generated medical records directly to the Federal health coordinator . With the TARP legislation targeting to help physicians and their income from Medicare and Medicaid, the merger from paper medical records to electronic saved the government money by not having to audit physicians' offices to ensure they are being ethical and ensuring privacy. The TARP also set up the National Coordinator for Health Information Technology to create a national database of electronic medical records for each person in the U.S. by 2014 . Having an electronic database, storing patient records that were monitored by federal health coordinators saved the government money which was desperately needed after the recent financial crisis at the time. The progress of technology early in the decade, and with the financial crisis towards the end of the decade, new acts and legislation were the main pushes to merge IT and Healthcare and develop electronic health records.

Besides the TARP legislation being passed and the 2008/2009 financial crisis, the growth of technology and accessibility in the early 2000s was so great and efficient that there would be numerous patient benefits of merging IT and Healthcare. By implementing an electronic health record and combining that with cloud computing, if a patient went to the emergency room, doctors would be able to pull up their health record, with the permission of the patient, to see their entire medical history and see exactly what type of medication they are on. With this resource, emergency room doctors could provide better care for the patient and this would greatly improve their diagnosis and chance to live in a life-threatening situation.

Benefits of Health Informatics

Many years ago, health records were on paper and at risk of being destroyed in a building fire or being lost in the theft. Patients had to visit their doctor to either take or make a copy of their health records to give to another doctor. It wasn't accessible elsewhere. With the advancement of information technology and healthcare, hospitals and physicians have been able to store all patient documents on secure servers. Nurses and doctors are now able to simply search for the patient's records and not go through numerous file cabinets. However, Health Informatics goes above and beyond just the accessibility of patient charts. In a hospital, for example, a patient who is going through surgery is allergic to a specific chemical so the system the hospital uses will warn the surgical team and nurses that the patient is allergic to it. It no longer requires relying on a person to read the paper chart and pass the correct information along. Clinics can now pull up past records of their patient, track what medication was provided at what time and dose.

There are many benefits of health informatics and they apply to all the parties within the healthcare system. That includes patients, physicians, doctors, and insurance providers. There is also a wide variety of benefits offered that range from something as basic as ease of communication to something as complex as a life-saving technology. With technology becoming more accessible and intelligent, implementing it with healthcare could potentially save someone’s life.

One of the biggest, and most widely used, benefits is Telehealth. TeleHealth delivery could be as simple as two health professionals discussing a case over the telephone or as sophisticated as using videoconferencing between providers at facilities in two countries . Telehealth is used by physicians to communicate with patients, order prescriptions, and offer other health services needed by patients. The Telehealth service can be broken down into three sections. Section one, Telemedicine. Telemedicine refers to real-time remote procedures of Telehealth such as cardiology, pathology, dermatology, surgery, and rehabilitation. Section two, Telehealthcare. Telehealthcare refers to monitoring patients remotely. Some of these services consist of home care, nursing, coaching, and rehab. Section three, E-health. E-health refers to the electronic health records EHR. Some benefits of E-health consist of E-Medical Records, E-Services, and E-Exchange. With these three different sections, the options and possibilities offered by IT in healthcare are revolutionary. Patients are offered endless resources no matter the circumstance and this ensures that they are receiving the best care possible. The benefits for healthcare professionals consists of making sure that they are equipped with the best tools to provide the best care for their patients. The possibility to seamlessly communicate with other professionals, who may have more experience on a topic but are in another country, maximizes the help that they can provide.

Another benefit modern IT brings to healthcare is the ability to use mobile applications to track and communicate with patients. A new emerging health standard called Fast Healthcare Interoperability Resources (FHIR), that uses the Representational State Transfer (REST) architecture, will allow developers to create apps that will allow healthcare providers to communicate with patients. One application that exemplifies this is AidIT. This enables patients to review and monitor their health, but also empowers health professionals to provide more personalized services while reducing medical errors . The scope of the app is to create an electronic health folder that stores personal information, general health information, diagnostic orders and lab results, medication, and a care plan. Using healthcare standards, the application would allow only certain entities to make changes and additions to certain records. For example, only the lab doctor can put in the results of a blood test, and only the patient’s doctor can prescribe medication. The app would prevent anyone without access to make suggestions to the patient .

With all these electronic and revolutionary advancements, one major concern that patients have is ethics and privacy. As beneficial as all of these services may be, how can patients be sure they are legal and ethical. Like any new service or advancement, there has to be a certain standard that is followed. That is where the HIPAA laws and medical ethical standards come in. All and any advancements in IT and Healthcare have to comply with HIPAA laws. On top of that, there are multiple medical ethics laws that these services and applications must abide by. The AidIT application described above is a perfect example of this. For the application to work it has to abide by HIPAA laws, and HL7 standards. Patients’ privacy and ethics are at the core of development and the application is designed so no ethical or privacy laws are violated.

Benefits to Patients

• Easy access to records on a website provided by the physician or hospital
• Results from scans and labs are digitized and ready to be faxed, emailed, or sent through the physician's network
• Medical records are quick to access through a mobile phone app
• Visiting multiple physicians is efficient due to having medical records on a global network level and not localized to one clinic
• Access to everything that was done to treat a disease: medication, lab results, vital statistics, and more
• Able to further educate themselves by having direct access to medical records. Patients can track their medication, symptoms, and how their prognosis is developing.

Benefits to Clinics and Hospitals

• Shared practice and knowledge about patients, medicines, and results
• Significant savings because data is shared, procedures don't have to be repeated
• Specialized care is increasing and hospitals can take advantage of health informatics to better treat patients across multiple specialists. Better coordination, healthier patients
• Treating patients is no longer about knowing the patient, it's all about the data now. This allows anyone to treat a patient equally without spending days, weeks, or months with the patient
• Decrease in errors and increase in efficiency
• Much higher quality care and safer care thanks to health informatics

Health Informatics Revolutionized The Healthcare Industry

• Studies have shown that hospitals have saved between $37 million and $59 million in a five year period
• Because of Electronic Medical Records (EMR), malpractice claims have dropped from 49 to 2 from a total of 189 Massachusetts medical practices
• Lab results have sped up with the use of EMR
• Patient record audits now have a faster turnaround time from 3.9 hours to 1.4 hours now that it's digital records and not on paper
• Best of all, healthcare professionals believe health informatics has saved time and reduced efforts

EMRs vs Paper Records to comply with HIPAA

Why Electronic Medical Records? Information technology (IT) can directly improve the quality of healthcare by providing medical service providers (referred to as provider) with accurate and timely information about the patient , The specific kinds of information about the patient that is useful in healthcare decision-making fall into two broad categories:

1. Health problems: This includes current health condition of the patient and any related symptoms, physical examination results and findings as well as medical test results. In addition, prior medical history is also part of the health record.
2. Patient Background: This includes specific patient data like Age, Gender, Race, Socioeconomic status, as well as risky behaviors like substance abuse, hazardous occupations, sports, hobbies, or sexual practices, exposures to damage causing occupational and environmental hazards, allergies, and family history.

Before the advent of Electronic Medical Records (EMRs), all information about the patient traditionally was kept in paper form in the physician’s office and hospital(s) wherever the patient had ever visited in the past. This kind of arrangement had several disadvantages. Some of the motivations for computerizing patient health records were to get over several difficulties of paper records, for example:

• Written records were often not clearly readable – Physicians are not well known for very legible handwriting.
• Written records may not be complete – a given provider’s records for a patient may not have a copy of records from other providers who treated a patient.
• Written records may be inaccurate – Usually the records are chronological and may not correlate when old information with updated data.
• Written records were sometimes not accessible by a given medical provider – they were only available where they were located. So a physician could not examine a patient’s records when the patient called the physician at home after hours.
• Written records had lack of uniformity and standards – There were no standards for paper records. Each provider may have used a different set of data fields that were saved in paper records.
• Written records had to be faxed – If a provider needed records from another provider, the records had to be faxed. This is a slow transmission mechanism especially for a large file.
• Where was no Physical Security – Paper records could be easily stolen, lost or accessed by anyone in the medical office.
• Paper records create sheer physical volume – Over time, health records could become voluminous.

HIPAA and Electronic Medical Records The disadvantages of paper-based patient records required that the information should be computerized. However, if the patient health information is stored (in a computer) or transmitted (between computers), it is subject to HIPAA laws. HIPAA stands for the Health Insurance Portability and Accountability Act, which was passed in 1996. One part of this Act governs how patient health information must be safeguarded while being stored or transmitted. HIPAA requires standardization for the health care information systems for data exchange and requires security standards for storing data. Thus, it is important that any EMRs must meet HIPAA security standards while being stored or transmitted between providers. Today the EMRs in use provide strong security features to be in compliance with the HIPAA requirements. Epic, which is a leading EMR in the U.S. has stated in a testimony to Congress that “Our software offerings include features for access logging during both clinical and non-clinical workflows and an integrated module for capturing and reporting on disclosures.” In addition, they state on their website that “The security of your information and data while using our Applications is very important to us. Our Applications employ a variety of technical safeguards to protect the confidentiality, integrity, and availability of your personal information including supporting Transport Layer Security (TLS)/Secure Sockets Layer (SSL) certificate technology and encryption.” Computerizing the process of entering, storing and retrieving the patient health information has provided many benefits besides counteracting the disadvantages of paper records that were mentioned earlier. Some of the advantages are as follows:

• Consistent data entry – Each provider can enter data in a consistent format in an EMR.
• Consistent and Easy-to-use Man-Machine Interface – Each provider sees the same GUI in order to enter or retrieve information from the EMR.
• Can utilize Laptop or tablets to access EMR – allows the provider to be mobile and not be tied to a desktop in a fixed place.
• Can automate collection and storage of data from diagnostic and monitoring equipment and test results from outside labs.
• Some EMRs may also utilize artificial Intelligence techniques to suggest a possible diagnosis.

How EMRs Improve Healthcare? In the bottom line, we want to see how the use of EMRs allows a medical practitioner to provide better healthcare to the patient.

The key technology for improving the availability of complete and accurate patient information is the EMR that allows storage of comprehensive information on the patient from a variety of providers including clinics(s), hospital(s), laboratory, pharmacy. Other technologies for handling patient information operate in conjunction with the EMR.

Since EMRs allow faster, easier, and more accurate entry and collection of information about the patient, the data can be added to the EMR during the interaction between the provider and the patient. Physical examination results including symptoms are now entered by physicians at or near the point of care, particularly with the aid of laptop computers or tablets. Consistent GUI with on-screen forms and drop-down menus allow complete data collection and reduce keying errors. Automatic date- and time-stamping of entries facilitates documentation and tracking of patient care and outcomes over time. Sometimes patient data can be captured directly from diagnostic and monitoring equipment, bypassing human data entry altogether. X-Ray, MRI and CATscan images, full-motion videos, and sound recordings can be digitized, stored, and transmitted electronically, often with high resolution. Patient background information and risk factors can be entered into computers by patients themselves, again with the aid of structured data entry and advanced human computer interface technologies. Basic demographic traits can be obtained from other computer databases (e.g., insurance eligibility files) through computer networks, again bypassing human data entry. Using EMRs with better search capabilities, providers can retrieve previously collected information about the patient— even at the point of care using laptops and tablets. The access is governed by HIPAA regulations and access is closely tracked by the EMRs and can be audited. Test results and associated reports including images and videos are easier to locate and review. Having quick access to the information about the patient from any location is crucial to providing better healthcare to the patient.

We have provided an overview of how computer-based Electronic Medical Records are a major contribution of IT in healthcare as they can overcome the many disadvantages of paper-based patient records. EMRs can be used to enter, store, transmit and retrieve patient information in compliance with HIPAA laws. Access to complete and accurate patient health information in EMRs facilitates better healthcare for the patient.

Telemedicine

Telemedicine is the use of telecommunication systems and software to provide medical services without an on-site appointment. Telemedicine platforms are frequently used for follow-up visits, appointments for chronic diseases, prescription management, consultations to specialists and many other medical services suitable to be delivered online through encrypted communications. The approach has been through a striking evolution in the last decade and it is becoming an increasingly important part of the American healthcare infrastructure.

The concept started in the 1950’s when a few hospitals and universities started researching on various ways of sharing medical data or images through telephone connections. In one of the first stages, two medical practices in Pennsylvania succeeded in transmitting radiological snapshots over the phone.

In the beginning, telemedicine was mostly utilized to serve as a communication channel between doctors and patients to specialists in a remote location. This was greatly beneficial to rural populations where specialists are not available. Throughout the following decades, the hardware and software needed for these remote visits was expensive and inefficient, so the presence of telemedicine, while increasing, was still limited. The internet era brought deep changes for the development of telemedicine. The wide spread of smart phones and tablets, equipped with high-quality video hardware and microphones, made the possibility of providing remote healthcare to patients in their own homes, workplaces or any other facilities as an economically viable alternative to on-site visits, both for specialty and primary healthcare.

Benefits for patients

• Minimized commuting expenses: A consultation only requires a computer device and internet connection, therefore it can be held virtually anywhere, avoiding commutes to the doctor's office and the time that such traveling entangles.

• Greater Access to health professionals: Patients are now able to reach out to health professional that are not in the same general area as they are to consult medical professionals.

• Work hours are not interrupted: The way Telemedicine operates, you can enjoy a consultation at the comfort of your own home, not having to spend time during morning hours which are typically used for work purposes. Also, due to the fact that your doctor can be in any time zone, your consultation can most likely be held at any time during the day.

• Improved privacy: Document's that are electronically held withstand a higher level of security standards that paper copies. In such a way, a document with test results can only be opened by the doctor or the patient and all activity is logged, whereas a paper document could be lost or anyone with access can pull up private documents.

• Less riskier appointments: A great amount of infection risks are produced by recurrent visits to the hospital. Most of these visits could be avoided by a telemedicine system.

• Fast access to healthcare: Internet of Things (IoT) technologies make it easy for patients who need permanent care to access healthcare using remote monitoring.

• Early pathology detection: Internet of Things (IoT) technologies help the patients to receive daily healthcare and fast treatment. By analyzing their data collected from different kinds of sensors.

Benefits for providers

• Less cancellations or rescheduled visits: Visits to the doctor's office can be done virtually anywhere which reduces the likelihood of patients missing an appointment or cancelling an existing one.

• Larger income: As more patients are taken care of the revenue of a doctor increases. Since telemedicine allows for an increase number of patients in a more efficient way, the revenue of the doctor increases proportionally. For instance, telemedicine would be more necessary during periods of pandemics and in the cases of patients living far away from healthcare providers. So, in these cases, care providers ensure the stability of the income.

• More efficient offices: Online patients don't need office resources like a waiting room, secretary or even paper records. Therefore, the efficiency at the office is increased by the use of IT systems. Which contributes to reducing the costs of running the business.

• Greater patient insight: All the data of the patient would be in one platform, allowing for its inspection and analysis.

• Easier payment procedures: It would be easier to keep track of health insurance details as no matter which doctor and which hospital the appointment was with, the patient's data would be verified prior to getting the appointment by the telemedicine platform.

• Enhance emergency services: By the use of IoT sensors, the healthcare provider can receive notifications from its patients as soon as the sensors detect emergency conditions..

• Reduce physician shortages: the widespread use of telemedicine could help healthcare providers contract with new doctors remotely.

Da Vinci Robot - The evolution of telesurgery

The da Vinci Robot is used for surgical procedures and controlled by a surgeon operating from a controlling unit. It was designed to make complex surgeries easier while keeping a minimally invasive approach. This device allows the surgeon to overcome the drawbacks of open and laparoscopic surgery, enhancing the surgeon's skills in terms of vision, precision, and control. It is crucial to note that the da Vinci robot is not autonomous; it requires the intervention and decision-making of a professional who acts as a human operator on all actions.

The da Vinci robot optimizes the range of motion of the human hand, counteracting the tremor and easing all movements of the surgeon. In this way, the chances of error related to other surgical systems are minimized. For instance, in a laparoscopy intervention, the surgeon must operate standing up and with a 2D vision of the area in which he is intervening. In contrast, the da Vinci robot provides a 3D view of the anatomy in question. Moreover, in laparoscopy, the surgeon is dependent on an assistant to correctly control the 2D camera, while in the da Vinci robot, the doctor manages the camera directly. Another aspect to consider is that the medical instruments used in laparoscopy typically provide limited movements while the robot can operate just as a human wrist would, allowing highly accurate movements in extremely small and risky spaces.

In 2008, the first pre‐clinical remote telesurgery trial using the da Vinci telesurgery prototype was conducted. The procedure was remotely controlled across a 17 MB/s bandwidth VPNe network spanning 2848 km round‐trip landline distance from London, Ontario, to Halifax, Nova Scotia, Canada. Although the results were subjectively successful, a 340 milliseconds latency was cited as a drawback. As the surgical system of telesurgery continues to emerge, so does competition to da Vinci, such as the Auris Health’s Monarch surgical robot, which was cleared by the FDA clearance in March 2018 to perform lung biopsies.

Concurrently to the growing capabilities of telesurgery robots grow the cyber-risks and vulnerabilities associated with them. A study conducted in 2015 by the University of Washington concluded that telesurgery robots can be hacked and surgeons could lose control to a malicious attacker. While different approaches to securing the process of telesurgery have been explored, it was not until 2019 that researchers proposed the comprehensive security framework. SecureSurgiNET aims to create a standard for best information security practices applied to the world of telesurgery. It has yet to be evaluated if SecureSurgiNET sufficiently address cyberrisk and whether or not it complies with regional privacy regulations, such as the Health Insurance Portability and Accountability Act (HIPAA).

Challenges in telemedicine

Reimbursement Issues: With the widespread use of telemedicine, there emerges the need for laws and regulations to regulate reimbursement services. Although, the existing law of reimbursement limits telemedicine spreading internationally. This law states that there is a specific requirement for telemedicine payment. For example, some insurance payers in the United States, like Medicare, have a Part B cost condition, which pays for telemedicine in certain terms. One of those terms is to allow payment for telemedicine only when patients are in the same location as the healthcare provider..

Lack of training: One of the initial challenges that may face the health providers, when applying telemedicine is the difficulty of training the medical staff. This difficulty comes from the transformation of the tools that have been used. However, telemedicine companies could have training programs for every new technology they install. In addition to this, telemedicine providers face another challenge regarding the patient usage of the technology. For example, a patient who is used to connecting with a physician for consultation may need help to set up the video conference. also, it is hard to call one of their family members to help assist them every time they need to set up a video call..

Patient's privacy: since all transactions in telemedicine are through the internet, and it increases privacy concerns. All patient's files and medical history will be shared with the medical staff and could be shared with the information technology team who's monitoring the system. Also, one of the most critical concerns about telemedicine privacy is the ease of accessing the patient's data..

New Professionals in Healthcare Informatics

In the healthcare industry because of technology advancing at a rapid pace, the healthcare industry is able to utilize technology in their own way. This means since healthcare can be done online and many other medical documents, this requires specialized positions to be made. Many positions have made and now require a certain group of people to manage the IT aspect in the healthcare industry. There are certifications in health informatics that will prove to a company that someone is certified in the industry. The certifications can focus on one of many areas like Data Analysis and Utilization, Data Reporting, Management of Health Information Systems and Processes, Health Informatics Training, and more. Positions like health information technology specialists, Chief Medical Information Officer, Medical Records and Health Information Technician, and much more. Based on the healthcare company, they can break down what medical or health information needs to be processed and carefully managed.

The health information technology (health IT) specialists position handles the technical side of a patient’s health information. They will build, instruct, or manage electronic health records (EHR). A Chief Medical Information Officer or CMIO, are IT professionals with a good background in healthcare. They manage, evaluate, and improve the organization's record-keeping system. A big part of their job is making sure their EHR are updated to the current systems. The Medical Records and Health Information Technician organize and manage health data such as EHR systems. Other positions like Nurse Informaticist and Health Informatics Director are more positions being made in the health IT industry.

In health IT the best way to show somebody that they have the type of skills to be a professional in health IT is by getting certified. This is called the Certified Health Informatics Systems Professional or CHISP for short. This combines healthcare and technical industry knowledge that is necessary for health IT specialists to know. This can range from software development to understanding the clinical setting.

There are other certifications like the RN-BC, CPHIMS, CAHIMS and RHIA. These can lead to different job positions within the health IT industry. RN-BC award those who are registered nurses and have a good understanding of informatics. The CPHIMS is for the management side of health IT which stands for Certified Professional in Healthcare Information and Management Systems. This examination requires more requirements and is divided into nine parts. The CAHIMS is for those who haven’t received much experience but are interested in informatics and are also pursuing a degree in health IT. CAHIMS stands for Certified Associate in Health Information and Management. The last certification is the RHIA and this focuses more on diagnostic classification and procedural of the medical process along with legal issues like storage, collection, and retrieval of protected health information. This is high standard in the management side and RHIA stands for Registered Health Information Administrator.

Like all health professions, professionals in healthcare informatics deal with issues of right and wrong. These professionals have an obligation to explore the ethical and moral challenges related to their work and practice. Ethical matters in informatics have become some of the most important and interesting debates in all health professions. These ethical issues are not just limited to confidentiality and privacy. They also include the appropriate selection and use of informatics tools; determining who should use those tools; obligations of system developers, maintainers, and vendors; and the use of computers to track clinical outcomes. It is important for professionals in this field to be familiar with system improvements and have adequate training and instruction.