Storing health records electronically
By Dr MILTON LUM
Electronic health records aid clinicians’ decision-making by providing access to patient information when they need it to incorporate evidence-based medical decisions. However, the implementation and use of such systems can bring certain risks.
Good medical practice requires the keeping of records about patients, as the medical record is essential to healthcare provision. The first medical records were developed by Hippocrates in the fifth century B.C. with two objectives, ie to accurately reflect the course of disease and to indicate the probable cause of disease.
Medical records assist in a patient’s healthcare by enabling the attending doctor(s) to structure his or her thoughts to make appropriate decisions; providing an aide memoire during subsequent consultations; providing information to other health professionals in patient care; providing information for inclusion in other documents, eg laboratory requests, referrals, medical reports; keeping patient information received from others, eg laboratory and imaging reports, correspondence and the transfer of the records when the patient changes care.
Good quality medical records contribute considerably towards raising the standards of care. They assist in the care of the population by assessing their health needs; identifying target groups for healthcare programmes; and supporting medical audit and clinical governance. Medical records also assist in meeting administrative, contractual and legal obligations.
The majority of medical records are paper records. However, there is an increasingly growing trend towards computerised records, which have been facilitated by information technology applications like computerised databases, electronic networks and smart cards. Unfortunately, many purchase decisions have not been based on well considered rationale but rather on keeping up with the Joneses.
Various definitions
Although there are various definitions of electronic health records (EHR), they are not mutually exclusive. The variation is in the emphasis, eg EHR as a source of information, clinical application, research or policy making; and representation of the clinical and chronological scope and the stakeholders involvement. EHR is also used to describe the systems holding the records as well as its management.
The Healthcare Information and Management Systems Society’s (HIMSS) definition is “a secure, real-time, point-of-care, patient-centric information resource for clinicians. The EHR aids clinicians’ decision-making by providing access to patient health record information when they need it and incorporating evidence-based decision support. The EHR automates and streamlines the clinician’s workflow, ensuring all clinical information is communicated, and ameliorates delays in response that result in delays or gaps in care. The EHR also supports the collection of data for uses other than clinical care, such as billing, quality management, outcomes reporting and public health disease surveillance and reporting.”
The International Organization for Standardization’s (ISO) definition is “a repository of information regarding the health of a subject of care, in computer-processible form.”
Personal health records (PHR) have been made available in the past two years by Google and Microsoft, ie Google Health and Healthvault respectively.
Google Health has defined PHR as a “patient-directed information tool that allows the patient to enter and gather information from a variety of healthcare information systems such as hospitals, physicians, health insurance plans, and retail pharmacies. PHRs allow people to access and coordinate their health information and share it with those who need it.” The challenge is obtaining the appropriate information, not too much and not too little, without any loss of integrity.
Benefits
EHR have the potential of creating a new paradigm in which all healthcare stakeholders have the potential to benefit from the information available. Electronic systems that link, integrate and aggregate individual records hold the promise of more co-ordinated and holistic healthcare from health professionals. Patient data can be extracted and transferred with greater ease and effectiveness, unlike paper-based systems.
The quality of care provided, its effectiveness, and incidences of specific events, particularly in relation to patient safety, eg medication errors, can be monitored and evaluated. There is potential for advances in public health using such systems as epidemiological studies have always been hampered by difficulties with data collection, which is laborious, time-consuming, poorly representative and simplistic. The development of new applications can facilitate analyses and improve knowledge of individual and population health.
There are also uses for EHR outside the health sector. It can influence employment, life insurance and a host of other activities.
However, no benefits come without risks. The risks of EHR are crucial for its uptake by patients, doctors, other healthcare professionals, employers and regulators. These are discussed below:
Confidentiality
The doctor’s duty of confidentiality is time honoured and dates from Hippocrates (400 BC), who stated: “Whatever, in connection with my professional practice or not, in connection with it, I see or hear, in the life of men, which ought not to be spoken of abroad, I will not divulge, as reckoning that all such should be kept secret.”
This duty is enshrined in the ethics codes of medical regulatory bodies worldwide. The Malaysian Medical Council’s Code of Professional Conduct states: “A practitioner may not improperly disclose information which he obtained in confidence from or about a patient.” This is elaborated in its document, Confidentiality, which states: “Patients have the right to expect that there will be no disclosure of any personal information, which is obtained during the course of a practitioner’s professional duties, unless they give consent. The justification for this information being kept confidential is that it enhances the patient-doctor relationship. Without assurances about confidentiality, patients may be reluctant to give doctors the information they need in order to provide good care. The professional duty of confidentiality covers not only what a patient may reveal to the practitioner, but also what the practitioner may independently conclude or form an opinion about.”
Compliance with this duty was not difficult in yesteryears when the relationship between patient and doctor was a direct one. However, the mode of healthcare delivery has changed in the past 50 years. It is now delivered by teams of healthcare professionals which include doctors, nurses, pharmacists, physiotherapists, occupational health therapists, etc. Others are also involved, eg hospital administrators, employers, insurance companies, managed care companies.
In general, doctors and other healthcare professionals who have direct contact with patients comply with the duty of confidentiality as it is inculcated into them during their training and practice. However, the more remote a person is from contact with patients, the more likely confidentiality will be breached, as many of those involved do not appreciate the significance of this duty.
The advent of EHR poses severe challenges to confidentiality. An analysis of patient information data will require going through numerous paper records. However, the situation with EHR is very different as a few clicks of the mouse can provide access to thousands or even millions of patient information data, notwithstanding usernames and passwords.
Privacy
Privacy is a much wider concept than confidentiality as it concerns a person’s right to control information about oneself and the right to exclude others from accessing it. One has the right to limit disclosure of personal information, its use by third parties and place limits on what doctors and other healthcare professionals can do with such information.
However, external factors like public interest may impinge upon this right. The balance of individual interests and external factors makes privacy a critical consideration in electronic health records.
Many countries have legislation that protects personal data, eg Privacy Act in Australia and Data Protection Act in the UK. The legislation came about because of increased threats to confidentiality and privacy resulting from the rapid expansion of computerised data systems, especially in healthcare. These laws have been amended with the ever increasing sophistication of computer technology.
Although there has been mention in the media from time to time of similar legislation, there is yet to be enacted in Malaysia legislation that protects personal data, let alone health data.
Security
The security of electronic information is an escalating concern with the increasing effectiveness of data retrieval engines and data mining techniques, which is reflected in the ever increasing theft of bank and credit cards.
Once health information is stored electronically, it is exposed to unauthorised access, misuse and abuse by “data thieves, blackmailers, and others with less than altruistic motives” (Anderson R. NHS-Wide Networking and Patient Confidentiality (1995) 311 British Medical Journal 5).
Medical identity theft is an issue that is of increasing concern as its victims may suffer great harm. Although the Federal Trade Commission estimated that its incidence comprised 3% of all identity thefts in 2005 in the US, its true incidence is unknown as it is under-researched and under-documented.
It is difficult to imagine how one could take a million pages of paper records out of a healthcare facility, but it is not at all difficult to remove the same in a thumb drive.
The harm to the affected individual may be medical or financial, or both. False entries in medical records are characteristic of medical identity theft.
The medical records of victims are altered without their knowledge and consent. The alterations may be minor or substantial. Harm can result from these false entries, which can lead to medical errors that may be life-threatening.
All levels of the healthcare system may be involved in medical identity theft, including healthcare providers, administrative staff, suppliers and information and communication technology vendors and service providers. The theft of a doctor’s username and password is often the beginning of medical identity theft.
The victims are often unaware of the medical identity theft as they do not usually have access to the entries in their medical records.
They are made aware of the theft in other ways, eg bill for services not received, receipt of another person’s bill, denial of medical insurance coverage, and so on.
Operability
One of the basic requirements of EHR systems is that they must be interoperable, ie clinical information about an individual must be always be meaningful even when transferred, both between various EHR systems and between versions of the same software. There has to be consistent recording of information so that effective comparisons can be made, if required.
The history of EHR is replete with examples of acquisition of different EHR systems and software only to find that they are not inter-operable, resulting in additional expenditure to correct a basic requirement. Integration is a nice word used to describe getting the EHR systems and software to “talk” to each other!
The structure and content of EHR is influenced by cultural, stakeholder and various other factors.
The attitudes of patients and doctors about the sensitivity of specific medical conditions influence their coding in the EHR systems and software. This has implications for integration between clinics and hospitals in the public and private sector.
The concept of a paperless hospital is everyone’s dream but it is only beneficial to the patient if the EHR is available whenever they are needed 24 hours a day and 365 days a year. On the day this article was written, the computer system in the hospital, where the writer was having a clinic session, failed (the system was “down”). Patients had to wait as they could not be registered; neither could their prescriptions be filled.
One shudders to think what would have happened had the hospital been paperless. Patients’ lives could have been put at risk and harm.
Going forward
Patients must have a central role in the introduction of EHR. A system acceptable to all is only possible if there is an understanding of patients’ and healthcare providers’ perceptions of EHR.
Patients and healthcare providers must be certain that:
● the EHR systems will be available whenever they are needed 24 hours a day, 365 days a year, and every year
● there is no change in the integrity of the information as it flows between healthcare providers
● there is proper and secure data storage in every part of the EHR system
● there are mechanisms that protect the storage and communication systems from intrusion
● the data will be properly managed and handled by each healthcare provider
Patients must also be certain that only authorised individuals will have access to the data, and that the data will only be used for legitimate purposes.
The factors that impact on the use of EHR were addressed succinctly in the document Critical issues for Electronic Health Records,which was the outcome of an expert workshop hosted by the Nuffield and Wellcome Trusts in November 2007 (Authors: P Singleton, C Pagliari and D E Detmer 2009).
Seven key requirements were identified for successful systems implementation, integration and maintenance of EHR. The authors stated: “For progress to be assured, regions, nations and the global health community must be engaged intelligently and iteratively.”
The requirements included:
1. A clear “vision” of the role of EHR and related information and communications technology (ICT)-aided healthcare interventions, supported by sub-component plans capable of assuring engagement of five key stakeholder groups:
a. patients, including informal caregivers
b. the public, including citizens, the media and public representatives
c. professionals, including clinical practitioners and allied health professionals, health informaticians, ICT technologists and technicians
d. managers/administrators/regulators/private payers
e. suppliers (application vendors, systems integrators, etc).
2. Clear and consistent communication (relevant messaging) of EHR content and meaning. This includes terminologies, classifications and standards to assure interoperability without loss of meaning, including relevant contextual content.
3. Systems that are able to aggregate, assess and manage the current base of knowledge and then …
4. Deliver that knowledge through decision support in a timely manner at the point of care. This is seen as critically important for both clinicians and patients (including their informal care-givers).
5. Systems that develop and support relevant workforce education and training.
6. Systems that support innovation in healthcare by enabling access to reliable data for research in the core sciences, as well as facilitating continuous improvements in healthcare quality.
7. Strategies for harnessing both experiential learning and opportunities to obtain evidence of the impact on quality, efficiency and safety.”
The workshop concluded that “All of the above assume that an information and communications infrastructure will be there to offer secure delivery of relevant information and knowledge on a right- and need-to-know basis. It is likely that this agenda will require another 20 years to reach maturity in a number of nations or regions of the world.”
Where does that leave us now?
Although medical records may have undergone changes with the advent of EHR, the underlying principles remain unchanged. Whilst there are potential benefits from EHR, there are also risks that have to be addressed. Patients and healthcare providers have to be assured and confident that confidentiality, privacy, security and operability issues are not compromised in any way before EHR can be accepted as the way forward.
● Dr Milton Lum is a member of the board of Medical Defence Malaysia. This article is not intended to replace, dictate or define evaluation by a qualified doctor. The views expressed do not represent that of any organization the writer is associated with.
Electronic health records aid clinicians’ decision-making by providing access to patient information when they need it to incorporate evidence-based medical decisions. However, the implementation and use of such systems can bring certain risks.
Good medical practice requires the keeping of records about patients, as the medical record is essential to healthcare provision. The first medical records were developed by Hippocrates in the fifth century B.C. with two objectives, ie to accurately reflect the course of disease and to indicate the probable cause of disease.
Medical records assist in a patient’s healthcare by enabling the attending doctor(s) to structure his or her thoughts to make appropriate decisions; providing an aide memoire during subsequent consultations; providing information to other health professionals in patient care; providing information for inclusion in other documents, eg laboratory requests, referrals, medical reports; keeping patient information received from others, eg laboratory and imaging reports, correspondence and the transfer of the records when the patient changes care.
Good quality medical records contribute considerably towards raising the standards of care. They assist in the care of the population by assessing their health needs; identifying target groups for healthcare programmes; and supporting medical audit and clinical governance. Medical records also assist in meeting administrative, contractual and legal obligations.
The majority of medical records are paper records. However, there is an increasingly growing trend towards computerised records, which have been facilitated by information technology applications like computerised databases, electronic networks and smart cards. Unfortunately, many purchase decisions have not been based on well considered rationale but rather on keeping up with the Joneses.
Various definitions
Although there are various definitions of electronic health records (EHR), they are not mutually exclusive. The variation is in the emphasis, eg EHR as a source of information, clinical application, research or policy making; and representation of the clinical and chronological scope and the stakeholders involvement. EHR is also used to describe the systems holding the records as well as its management.
The Healthcare Information and Management Systems Society’s (HIMSS) definition is “a secure, real-time, point-of-care, patient-centric information resource for clinicians. The EHR aids clinicians’ decision-making by providing access to patient health record information when they need it and incorporating evidence-based decision support. The EHR automates and streamlines the clinician’s workflow, ensuring all clinical information is communicated, and ameliorates delays in response that result in delays or gaps in care. The EHR also supports the collection of data for uses other than clinical care, such as billing, quality management, outcomes reporting and public health disease surveillance and reporting.”
The International Organization for Standardization’s (ISO) definition is “a repository of information regarding the health of a subject of care, in computer-processible form.”
Personal health records (PHR) have been made available in the past two years by Google and Microsoft, ie Google Health and Healthvault respectively.
Google Health has defined PHR as a “patient-directed information tool that allows the patient to enter and gather information from a variety of healthcare information systems such as hospitals, physicians, health insurance plans, and retail pharmacies. PHRs allow people to access and coordinate their health information and share it with those who need it.” The challenge is obtaining the appropriate information, not too much and not too little, without any loss of integrity.
Benefits
EHR have the potential of creating a new paradigm in which all healthcare stakeholders have the potential to benefit from the information available. Electronic systems that link, integrate and aggregate individual records hold the promise of more co-ordinated and holistic healthcare from health professionals. Patient data can be extracted and transferred with greater ease and effectiveness, unlike paper-based systems.
The quality of care provided, its effectiveness, and incidences of specific events, particularly in relation to patient safety, eg medication errors, can be monitored and evaluated. There is potential for advances in public health using such systems as epidemiological studies have always been hampered by difficulties with data collection, which is laborious, time-consuming, poorly representative and simplistic. The development of new applications can facilitate analyses and improve knowledge of individual and population health.
There are also uses for EHR outside the health sector. It can influence employment, life insurance and a host of other activities.
However, no benefits come without risks. The risks of EHR are crucial for its uptake by patients, doctors, other healthcare professionals, employers and regulators. These are discussed below:
Confidentiality
The doctor’s duty of confidentiality is time honoured and dates from Hippocrates (400 BC), who stated: “Whatever, in connection with my professional practice or not, in connection with it, I see or hear, in the life of men, which ought not to be spoken of abroad, I will not divulge, as reckoning that all such should be kept secret.”
This duty is enshrined in the ethics codes of medical regulatory bodies worldwide. The Malaysian Medical Council’s Code of Professional Conduct states: “A practitioner may not improperly disclose information which he obtained in confidence from or about a patient.” This is elaborated in its document, Confidentiality, which states: “Patients have the right to expect that there will be no disclosure of any personal information, which is obtained during the course of a practitioner’s professional duties, unless they give consent. The justification for this information being kept confidential is that it enhances the patient-doctor relationship. Without assurances about confidentiality, patients may be reluctant to give doctors the information they need in order to provide good care. The professional duty of confidentiality covers not only what a patient may reveal to the practitioner, but also what the practitioner may independently conclude or form an opinion about.”
Compliance with this duty was not difficult in yesteryears when the relationship between patient and doctor was a direct one. However, the mode of healthcare delivery has changed in the past 50 years. It is now delivered by teams of healthcare professionals which include doctors, nurses, pharmacists, physiotherapists, occupational health therapists, etc. Others are also involved, eg hospital administrators, employers, insurance companies, managed care companies.
In general, doctors and other healthcare professionals who have direct contact with patients comply with the duty of confidentiality as it is inculcated into them during their training and practice. However, the more remote a person is from contact with patients, the more likely confidentiality will be breached, as many of those involved do not appreciate the significance of this duty.
The advent of EHR poses severe challenges to confidentiality. An analysis of patient information data will require going through numerous paper records. However, the situation with EHR is very different as a few clicks of the mouse can provide access to thousands or even millions of patient information data, notwithstanding usernames and passwords.
Privacy
Privacy is a much wider concept than confidentiality as it concerns a person’s right to control information about oneself and the right to exclude others from accessing it. One has the right to limit disclosure of personal information, its use by third parties and place limits on what doctors and other healthcare professionals can do with such information.
However, external factors like public interest may impinge upon this right. The balance of individual interests and external factors makes privacy a critical consideration in electronic health records.
Many countries have legislation that protects personal data, eg Privacy Act in Australia and Data Protection Act in the UK. The legislation came about because of increased threats to confidentiality and privacy resulting from the rapid expansion of computerised data systems, especially in healthcare. These laws have been amended with the ever increasing sophistication of computer technology.
Although there has been mention in the media from time to time of similar legislation, there is yet to be enacted in Malaysia legislation that protects personal data, let alone health data.
Security
The security of electronic information is an escalating concern with the increasing effectiveness of data retrieval engines and data mining techniques, which is reflected in the ever increasing theft of bank and credit cards.
Once health information is stored electronically, it is exposed to unauthorised access, misuse and abuse by “data thieves, blackmailers, and others with less than altruistic motives” (Anderson R. NHS-Wide Networking and Patient Confidentiality (1995) 311 British Medical Journal 5).
Medical identity theft is an issue that is of increasing concern as its victims may suffer great harm. Although the Federal Trade Commission estimated that its incidence comprised 3% of all identity thefts in 2005 in the US, its true incidence is unknown as it is under-researched and under-documented.
It is difficult to imagine how one could take a million pages of paper records out of a healthcare facility, but it is not at all difficult to remove the same in a thumb drive.
The harm to the affected individual may be medical or financial, or both. False entries in medical records are characteristic of medical identity theft.
The medical records of victims are altered without their knowledge and consent. The alterations may be minor or substantial. Harm can result from these false entries, which can lead to medical errors that may be life-threatening.
All levels of the healthcare system may be involved in medical identity theft, including healthcare providers, administrative staff, suppliers and information and communication technology vendors and service providers. The theft of a doctor’s username and password is often the beginning of medical identity theft.
The victims are often unaware of the medical identity theft as they do not usually have access to the entries in their medical records.
They are made aware of the theft in other ways, eg bill for services not received, receipt of another person’s bill, denial of medical insurance coverage, and so on.
Operability
One of the basic requirements of EHR systems is that they must be interoperable, ie clinical information about an individual must be always be meaningful even when transferred, both between various EHR systems and between versions of the same software. There has to be consistent recording of information so that effective comparisons can be made, if required.
The history of EHR is replete with examples of acquisition of different EHR systems and software only to find that they are not inter-operable, resulting in additional expenditure to correct a basic requirement. Integration is a nice word used to describe getting the EHR systems and software to “talk” to each other!
The structure and content of EHR is influenced by cultural, stakeholder and various other factors.
The attitudes of patients and doctors about the sensitivity of specific medical conditions influence their coding in the EHR systems and software. This has implications for integration between clinics and hospitals in the public and private sector.
The concept of a paperless hospital is everyone’s dream but it is only beneficial to the patient if the EHR is available whenever they are needed 24 hours a day and 365 days a year. On the day this article was written, the computer system in the hospital, where the writer was having a clinic session, failed (the system was “down”). Patients had to wait as they could not be registered; neither could their prescriptions be filled.
One shudders to think what would have happened had the hospital been paperless. Patients’ lives could have been put at risk and harm.
Going forward
Patients must have a central role in the introduction of EHR. A system acceptable to all is only possible if there is an understanding of patients’ and healthcare providers’ perceptions of EHR.
Patients and healthcare providers must be certain that:
● the EHR systems will be available whenever they are needed 24 hours a day, 365 days a year, and every year
● there is no change in the integrity of the information as it flows between healthcare providers
● there is proper and secure data storage in every part of the EHR system
● there are mechanisms that protect the storage and communication systems from intrusion
● the data will be properly managed and handled by each healthcare provider
Patients must also be certain that only authorised individuals will have access to the data, and that the data will only be used for legitimate purposes.
The factors that impact on the use of EHR were addressed succinctly in the document Critical issues for Electronic Health Records,which was the outcome of an expert workshop hosted by the Nuffield and Wellcome Trusts in November 2007 (Authors: P Singleton, C Pagliari and D E Detmer 2009).
Seven key requirements were identified for successful systems implementation, integration and maintenance of EHR. The authors stated: “For progress to be assured, regions, nations and the global health community must be engaged intelligently and iteratively.”
The requirements included:
1. A clear “vision” of the role of EHR and related information and communications technology (ICT)-aided healthcare interventions, supported by sub-component plans capable of assuring engagement of five key stakeholder groups:
a. patients, including informal caregivers
b. the public, including citizens, the media and public representatives
c. professionals, including clinical practitioners and allied health professionals, health informaticians, ICT technologists and technicians
d. managers/administrators/regulators/private payers
e. suppliers (application vendors, systems integrators, etc).
2. Clear and consistent communication (relevant messaging) of EHR content and meaning. This includes terminologies, classifications and standards to assure interoperability without loss of meaning, including relevant contextual content.
3. Systems that are able to aggregate, assess and manage the current base of knowledge and then …
4. Deliver that knowledge through decision support in a timely manner at the point of care. This is seen as critically important for both clinicians and patients (including their informal care-givers).
5. Systems that develop and support relevant workforce education and training.
6. Systems that support innovation in healthcare by enabling access to reliable data for research in the core sciences, as well as facilitating continuous improvements in healthcare quality.
7. Strategies for harnessing both experiential learning and opportunities to obtain evidence of the impact on quality, efficiency and safety.”
The workshop concluded that “All of the above assume that an information and communications infrastructure will be there to offer secure delivery of relevant information and knowledge on a right- and need-to-know basis. It is likely that this agenda will require another 20 years to reach maturity in a number of nations or regions of the world.”
Where does that leave us now?
Although medical records may have undergone changes with the advent of EHR, the underlying principles remain unchanged. Whilst there are potential benefits from EHR, there are also risks that have to be addressed. Patients and healthcare providers have to be assured and confident that confidentiality, privacy, security and operability issues are not compromised in any way before EHR can be accepted as the way forward.
● Dr Milton Lum is a member of the board of Medical Defence Malaysia. This article is not intended to replace, dictate or define evaluation by a qualified doctor. The views expressed do not represent that of any organization the writer is associated with.
MOHD ADHA MOHD ZAIN (ADHA ZAIN)
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