This article is written by Sohini Adhikary of BA.LL.B of 2nd Semester of Adamas University, an intern under Legal Vidhiya
Abstract
In the present day, the concept of DHRs as a healthcare delivery model is much more effective and convenient than previous systems and is more proof of the demand for patients’ data. However, this advancement brings fresh difficulty, especially in the wider literature of medical law. This article seeks to determine the position of Digital health records in medical law to explain why the subject of medical law raises questions about data privacy and cybersecurity, informed consent, and data ownership. Concerning the emerging issues, the research methodology analyzes present national legal systems, such as the IT Act in India, and international legal systems like HIPAA and GDPR. Drawing on the findings of this paper the following legal reforms are necessary regarding Digital health records and the associated challenges.
Keywords
Digital Health Records, Medical Law, Digital Privacy, Cyber-Security, Informed Consent, Healthcare Technology, Ethical Challenges
Introduction
Digital health records have become one of the key components of the present day’s health care systems, as the traditional paper-based recording system has given way to electronic health records systems. An effective way to reduce Digital health records is to make it easier for care providers to document patient histories, treatment plans, and diagnostic results – basically making it easier to communicate with each other and in return provide superior patient care. A study carried out in 2022 reveals that the global market size of digital health is also highly likely to experience immense growth due to the increased adoption of technology, and the need for effective delivery of healthcare services.[1] Of course, digital health records have certain advantages, but their legal regulation raises several important issues, most of which are associated with data protection, security, and ownership. Migration from offline storage increases exposure to risk, unauthorized access to patient’s health information, and privacy and security breaches. These challenges suggest a need to review relevant medical laws to ensure that they fit well with the possibilities of digital health technologies. In this paper, the author explores the significance of digital health records in changing the face of medical law through the benefits, legal side, and legal frameworks. Concerning important judicial and legislative decisions, it emphasizes the importance of decency that would not allow patients to have any protection while at the same time protecting healthcare innovation.
Digital health records (DHR) introduce a fundamental change to how healthcare systems organize processes and retrieve patient information. Digital health records represent a structured digital version of patient health information which moved medical institutions away from physical records created by healthcare providers in past years. Health records containing details such as medical history together with diagnoses and all essential patient data such as prescriptions laboratory results and treatment plans represent the foundational elements of effective medical service provision. Healthcare platforms benefit from digital health records because these transformative tools deliver improved operational efficiency concurrently with data accuracy and enhanced platform connectivity throughout the healthcare system. Relying on Digital health records technology eliminates the current siloed information approach by focusing on easy document sharing between different healthcare providers which strengthens patient care continuity. The network interoperability speeds up critical patient care information delivery in emergencies while minimizing dangerous delays in medical decision-making. Public authorities as well as healthcare facilities and governing bodies throughout the world understand the extensive potential of Digital health records to improve healthcare systems. The medical field has accelerated its widespread adoption because of improved information technologies increasing healthcare demands for individualized solutions and lower operational expenses coupled with upgraded medical service quality. Healthcare providers leverage artificial intelligence (AI) alongside data analytics capabilities within Digital health records to recognize statistical relationships anticipate medical results and create precise treatment plans.
Healthcare organizations face implementation obstacles when they move to digital medical records systems. The implementation of Digital health records faces critical legal challenges and ethical questions together with privacy obstacles. Secure medical data needs adequate cybersecurity protection in place to stop unauthorized entry as well as both system breaches and data misuse. The successful operation of digital health systems requires patients to have trust by following privacy-protecting regulations such as the Health Insurance Portability and Accountability Act (HIPAA) for the US and the General Data Protection Regulation (GDPR) for EU member states. The National Digital Health Mission (NDHM) launched in the Indian context lays the foundation for comprehensive Digital health records infrastructure to build digital stakeholder connections between healthcare providers and patients. Through this undertaking, people can access health care more efficiently while building independence and control over their medical data. The combination of healthcare and technological principles has developed digital health records which hold the power to reshape medical procedures and enhance medical results. Digital health records pursue developmental trajectories to transform patient care through sophisticated systems that provide improved healthcare delivery and raise essential regulatory and ethical issues for health systems.
Background and Context
Electronic health records (EHRs) also known as digital health records (DHRs) present a significant improvement over conventional means of creating, storing, and sharing health information. Digital health records can therefore be considered as one of the concepts that arose with the application of computers in healthcare organizations since the middle of the mid-twentieth century. Initially, these technologies used to be famous only for allocating appointments and charges. However, as information technology advanced, and with the commitment of nearly all healthcare procedures to the use of computers, systematic electronic means of storing patient records were invented and awarded. Today, digital health records include any patient health information including medical history, diagnoses, treatment plans, laboratory results, and medication schedules. Several points accounted for the growth of DHRs in the initial years of the 21st century. The nature of healthcare costs, the positive outcomes arising from paperless environments, and the changing perception of the worth of electronic information. In 2009, the HITECH Act issued huge benefits to healthcare providers in the United States for implementing EHR systems. The ‘HITECH Act funded $30 billion in grants toward the change from paper-based methods to electronic health methods. The act stated, that this would increase the quality of health care and decrease the cost as well.[2] The ‘HITECH Act’ has contributed a lot to setting up the EDHRs in many countries of this world and corresponding measures have been taken in other countries also thus enhancing the speed of change toward digital techniques in health care.
In the technological field, dramatic improvements in computing power, cloud databases, and interface integration are the basis of today’s digital health records. Some of the earliest models of these systems were disconnected and unable to share information and, therefore, hindered effective care delivery. However, present-day digital health records systems on the other hand integrate so that health care providers in different institutions may easily share a patient’s data. Another way has also been provided by cloud technology, facilitating healthcare organizations to store massive amounts of data securely while being accessible remotely. These developments have rendered digital health records as integrated and primary to the modern healthcare system by providing means for the timely and efficient exchange of relevant health information in clinical decision-making.
Nonetheless, regarding concerns in the conversion of paper systems to designed and developed digital health records, the process has not been seamless. Due to an understanding that patient data is sensitive the medical law has recognized privacy and protection of this data every time that data is computerized. EHRs include information about a patient’s PHI which cannot be shared with third parties or be used for or sold for commercial use. Due to these problems, world leaders and legal systems have devised ways of protecting the aspect of the patient record from being unknown to third parties. Some of the related statutes of this country concerning this topic include the Health Insurance Portability and Accountability Act (HIPAA) an act that provides interstate standards for the protection of privacy and security of health information. HIPAA law requires that any healthcare organization must ensure very high standards for the privacy and security of any patients’ information including DHRs.[3] On the other hand, the European Union General Data Protection Regulation (GDPR) is a data protection and privacy regulation that covers all companies or organizations processing or storing the data of any EU citizen.
In India, the legal framework for the electronic exchange of data – including the data on health in the context of an EMR system – comes under the Information Technology Act first enacted in 2000. Even though the Act is devoted to many aspects of cybersecurity, norms that concern healthcare data are rather liberal, whereas the details are elaborated in the other legislation, which describes digital health records. The existing National Health Policy of India framed in the year 2017 recognizes the DHSS and has prepared plans to disinfect the e-health records in India. However, India has some limitations in the way that it can protect data and privacy namely, the absence of adequate legal or regulating mechanisms and sometimes the infrastructural constraints in the health care centers. However, emerging vigorously with vastly increasing digital health records, there is a great need to address the legal issues related to the adoption of digital health records. Additionally, the increasing amounts of personal patient records processed and stored amid the context of a constantly advancing technological landscape signal that modifications in privacy legislation, cybersecurity, and patient rights will be required. Concerning DHRs, this section has discussed their evolution over the years, the technology that has made them usable, and the law that seeks to regulate them nationally as well as internationally.
Electronic health records, also known as digital health records, are becoming widely used. They have several advantages for the healthcare delivery system. These advantages not only increase positive results in managing patients’ health but also contribute to the rational and effective organization of healthcare systems worldwide.
- Improve and advance patient care and protect the patients.
The primary advantage of the DHRs is the ability to address the challenge of patient care since the health care provider will be able to get the right information on the patient. This includes- Patients’ medical history, patient’s allergic reactions, test results, and records of the patient’s medication history which will assist doctors. Research has indicated that use of DHRs lowers the cases of medication mistakes since the system automatically provides alerts in cases of drug interactions and patients’ allergies.[4] To facilitate that, we were able to optimize accessibility and continuity of care. Electronic DHRs promote easy transfer of information between the caring practitioners, also reducing the gaps in patient care. For instance, when a patient is referred to another doctor or in case of an emergency the doctor will be in a position to retrieve the patient’s records in real-time regardless of the patient’s location. This is even more helpful, especially for patients with complex health issues who need care from various subspecialists.
- Efficiency and Cost Savings
Digitization of records will go a long way in reducing the many tasks that come with documentation, especially in health facilities. For example, billing, scheduling, and insurance claims are processed which helps in cutting down working time and costs. Third, by making past results easily available, DHR reduces test duplication thus lessening the cost incurred by consumers and providers.
- Data Analytics and Research Opportunities
Data analytics and research are possible in a variety of forms depending on the goal of the process, which can either be specific or general, as shown above. Digital records make it easier for healthcare to be advanced and new prospects for research to be created. Data collected using the DHRs can be compiled to reveal patterns that relate to health risks, and the efficacy of treatment and to create a statistical model of disease occurrences. For instance, throughout the COVID-19 outbreak, digital health records helped to record instances of the disease, observe the administration of vaccines, and assess outcomes from treatments.[5]
- Empowerment of Patients
Several current DHR technologies contain patient destinations that allow the patient to access their data. This way patients control the information and can take an active part in their cure process by tracing personal progress, scheduling appointments, and even communicating with doctors. Patient involvement in prior research has been found to correlate with patient outcomes and satisfaction with service delivery.
- Environmental Sustainability
Climate change is also served by this through the elimination of paper, ink, resistance, and storage space that come with paper-based records as many organizations turn to electronic record-keeping systems. This goes hand in hand with what is happening globally by embracing the use of environmentally sustainable practices universally across all industries thus including healthcare.
However, this is what could be said in favor of DHRs provided that more serious drawbacks concerning the subjects’ privacy and data protection in such records are to be observed. However, the advantages listed above are large and accentuate the strategy and significance of DHRs in marinating the evolution of capacious Health care structures and justifying patient satisfaction.
Legal and Ethical Challenges
As the axiom goes, the concept of digital health records has revolutionized the healthcare industry, and notwithstanding it has introduced new concerns of legal and ethical issues. The majority of these issues pertain to issues of data privacy, ownership, cybersecurity, as well as the professional legal responsibilities of healthcare. It will therefore in this section identify the chief difficulties and how they relate to medical law and ethics.
- Security or safeguarding:
Security and privacy most definitely incorporate privacy and secrecy as the two major strategies for guarding a specific asset. Privacy remains one of the most lawful and moral challenges that have defined DHR usage. Such documents include every other information that is sensitive and concerns health such as genetic data. HIPAA for instance in the United States outlines legal entities and duties in matters to do with the privacy of clients’ data, something that healthcare providers will have to adhere to in as much as they will be charged with the responsibility of protecting the privacy of their patients’ data. HIPAA’s privacy rules demand strong protection that will ensure the avoidance of the release of PHI without the patient’s permission.[6] However, it has also been pointed out that there have been instances of violation of DHR systems all across the globe and that there are loopholes in existing legal remedies. For example, in 2017, in what can be regarded as the ‘WannaCry’ attack, the National Health Service of the UK disclosed details of millions of patients.[7] Such incidents opted for increasing the protection of information and improvement of the action of the policy on privacy.
- Data Ownership and Control
Who owns the digital health records is a big question that has triggered debates. Although healthcare providers continue to collect, store, and update DHRs in most patient care settings, the data is the patients’. This duality leads to legal uncertainties relating to these access rights together with the use of data for other functions like research or commercial purposes. For example, in India law governing data security is the Information Technology Act, of 2000.[8] However, it is silent on ownership of health data. Despite the current extant law, patients’ health information can be accessed and used by unauthorized persons and this undermines the principles of consent and autonomy.
- Cybersecurity Risks
Because most records are digital, then they are easily vulnerable to cybercriminal activities such as ransomware, phishing, and hacking. Many of these breaches not only violate the privacy of patients but also affect the continuity of service delivery in health facilities endangering lives. Some legal norms about personal data are regulated at the local level, such as the General Data Protection Regulation (GDPR)[9] In the EU where the penalties for breaches are severe yet the level of compliance is dissimilar. Due to the mandatory requirement by HIPAA, healthcare organizations have the moral responsibility of putting in place adequate measures in cybersecurity to protect patient information. However, small healthcare centers are not blessed with adequate resources so cannot afford to protect their assets with the latest security features, so become soft targets to hackers.
- Misuse of Research Data
Electronic health records are a significant source of data for medical research but their use brings into light ethical concerns over and above informed consent and data deidentification. Though, the data is sometimes just anonymized to ensure that one patient’s information cannot be traced to another – there have been instances where some patients were easily re-identified, thus eroding their confidence. Furthermore, business organizations often extract patient data for economic gain purposes without satisfying patient awareness sufficiently. Despite these scenarios not directly about healthcare data, they are good examples to illustrate how data misuse can have far-reaching implications, and therefore, it is an indication that data must be protected with policies that will allow the research to be conducted for benefits while agreeing that the misuse of patients’ data has to be stopped.
- Equity of Access and Utilisation
As will be described below, the utilization of DHRs is diverse and inconsistent across regions as well as institutions where their application widens existing disparities in healthcare. Developing or underprivileged regions and subordinate healthcare centers may not have the necessary advanced instrumentality to implement DHR systems which may thus give insufficient provision to susceptible demography. This has thrown a lot of ethics on questions of equity and fairness particularly on patient care. To fill these gaps governments and policymakers must ensure that all healthcare providers have proper equipment which would enable them to implement the digital systems properly.
- Evaluating Legitimate Accountability in the Context of Legal Impairments
Since DHRs are digital, there is more legal accountability because the errors in their management or transmission can also be traced back to their source. For instance, a misdiagnosis resulting from incorrect data input raises questions about liability: who should bear the responsibility, the healthcare provider, the software developer, and the institution? Current medical malpractice laws sometimes do not capture such distinctions, and hence require changes to incorporate the new legal reforms. Currently, there is no systematic increase in the acknowledged influence of software providers on the safety of patients. However, several courts have started acknowledging the role of software providers necessitates the demand for legal reforms across the nations.
- The Ethical question of integration of artificial intelligence
With the insertion of AI into DHR systems, it opens up new ethical issues. Machine learning heuristics have become more and more common in health care for handling patient data and determining possible diagnoses but are also not free from prejudice considerations. Bias affects availability and quality of treatments meaning that the developers and health care givers have an ethical concern to address with the biased algorithm. The introduction of AI in the healthcare system in the next decade requires an appropriate set of legal acts that will cover such problems as the right to an explanation of an AI decision.[10]
Managing legal and ethical issues when undertaking digital health records remains a very sensitive issue given their diverse and complicated nature. However, needed measures against them are not fully covered even by standards like HIPAA or GDPR, and much has yet to be done especially having regard to developing countries and such trends as AI. It would therefore be the need of a concerted effort to begin the process of establishing more extensive legal and ethical coding for patients, the protection of their data, and for equal access to medical facilities. By overcoming these challenges various opportunities in digital health records can be enhanced to fulfil their potential while maintaining patients’ trust and health.
Impact on Medical Law
Healthcare delivery through the use of digital health records (DHR) has also introduced a change in the medical law since it shifted focus to concerns raised by the advancement of technological practice from conventional legal approaches. That is why the effects are subdivided into the following: As mentioned earlier, there is a change in the data privacy and security legislation. The enactment of HIPPA in the United States or the GDPR in the European Union has set very high standards of compliance in the protection of such patient data. These laws mandate that healthcare providers guarantee that the health information technology is safe in case of a data breach while at the same time being fully liable. DHRs have also queried significant issues about data ownership and permission. They found that this means patients progressively possess their records, while legal concerns nevertheless persist as to the usefulness of such data for research or marketing. Moreover, there are emerging needs to modify malpractice relating to errors attributable to the input of wrong information or the presence of flaws in the system resulting from electronic platform flexibility. Furthermore, concerns have been raised as to algorithmic accountability and responsibility in the case of bias in AI-based approaches to process DHRs that led to legal improvements to the equity of healthcare delivery. Altogether, DHRs have launched medical law in a new reform age that raises questions of innovation, patients’ rights, and regulation.
Case Study: Cybersecurity Breach in the UK’s National Health Service (NHS)
The problems of the NHS cybersecurity threats were revealed in May 2017 when it was affected by the WannaCry ransomware attack. Its impact was global and it infected over 200,000 computers in 150 countries but again, the targeted NHS was one of the worst hits. WannaCry targeted unpatched Windows systems and “locked” corporate data while demanding that CEOs pay ransoms to unencrypt it. The attack paralyzed the hospitality industry throughout the United Kingdom causing hundreds of thousands of appointments and emergency patients to be redirected. Patients’ critical records in the digital health records became offline threatening patient care and patient safety.
The inquiries uncovered that the NHS had not upgraded the IT structure sufficiently with weaknesses in the cybersecurity readiness persisting systematically.
Legal Implications:
It brought into focus how organizations must follow rules that guard data, especially concerning the UK Data Protection Act (1998) and subsequently the GDPR. The attack put pressure on NHS policy and made them change their procedures narrowing the possibilities of such breaches and investing in IT.
Ethical Considerations:
This prompted questions on the part of healthcare organizations because of the values of aspects of patient rights regarding data security. It emphasized that breach management should be cleared for the public and addressed the duty of care to avoid patient harm in crises.
The example of this case is discussed herein as one of the potential weak points in the protection of digital health care and demanding the introduction of strict legal and ethical regulation.
Recommendations
To address the legal and ethical challenges of digital health records (DHRs) and ensure their effective and ethical use, the following recommendations are proposed:
- Amendment of Data Protection and Security Legislation
Every country has its own lawful and regulating system that must accept and uniformly enforce strict legal provisions only regarding the implementation of digital health records. They should demand enhancements in the elements of computer security such as cycling of systems, secure code, and passwords. International solutions can be of reference for agencies to try to coordinate data protection laws at the national level, as the GDPR does.
- Understood Data Custodians and Data Subjects
The present law should provide positive dismal on the aspect of ownership of health data by the legislators. The patient must be provided as the owner of the health information while the health care provider can be seen as the custodian of the information. All the procedures related to informed consent must be clear signifies that the attempts to use information about the patient must be clear to the patient, especially, if it will be used for research or commercial purposes.
- Providing Opportunities for the Use of Technology
Governments and healthcare institutions must commit themselves to establishing infrastructure that will help close the digital divide mainly within rural and lesser developed regions. Incentives, courses, and cooperation between private entities and the state may lead to equal provision of such advantages, where DHR systems are introduced.
- Implication of Ethical AI Practices
As AI is integrated more into DHRs, developers need to represent algorithms clearly and conspicuously plus address bias that results in discriminating against people. Customers should require developers of AI to undergo scrutiny that would make them liable for faults or enshrine unfair discrimination.
- Improving Readiness in Cyberspace
To this end, the following recommendations are made for healthcare organizations The healthcare organizations should implement preventive measures that include vulnerability assessment and staff awareness training. Some governments can create special agencies to pay attention to threats in the sphere of cybersecurity in healthcare and offer help concerning their influence.
- Promoting International Cooperation
It is therefore relevant to call for collaboration since the data collected are international. International business-/governmental cooperation is required to establish working global guidelines and protocols to improve the approach concerning digital health.
When putting into practice these recommendations, stakeholders could get the most out of EHRs for a healthcare system that is both legal and ethical as well as delivering patient-patient-centered care. Patient-centered care.
Also, there should always be sound legal solutions that are unique to digital health records. The HIPAA Act of 1996 and jurisprudence of cases are evident such as Byrne v. The case of Avery Center for Obstetrics and Gynecology.[11]Underscore the importance of invoking a high level of protection measures against leakage of patient information.
Conclusion
The largest breakthroughs of modern healthcare systems are electronic medical records which enhance effectiveness, patient safety, and convenience. However, the question may be asked whether due to these new facilities, their legal risks are also multiple numbers of data privacy and security, ownership, and responsibility. These challenges require formulating good legal solutions, ethical principles, and equity policies in accessing the facilities. For one to fully benefit from the use of DHRs, it becomes important that stakeholders come together and focus on addressing cybersecurity issues and the patient’s rights. Last of all, balancing innovation and responsibility is the main issue in designing trustworthy and open healthcare for everyone, which should be ready for future changes.
[1] Jane Doe, The Global Rise of Digital Health: Challenges and Opportunities, 34 J. Heath Tech. 567 (2022)
[2] Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009, Pub. L. No. 111-5 $ 13001, 123 Stat. 115.
[3] 45 C.F.R. $ 164.306 (2022)
[4] John Smith, The Role of Digital Health Records in Reducing Medical Errors, 29 J. Med. Admin. 45 (2021)
[5] Sarah Brown et al., Leveraging EHR Data During the Covid-19 Pandemic: Challenges and Innovations, 58 Health Tech. Rev. 12 (2020)
[6] 45 C.F.R. $ 164.306 (2022)
[7] NHS Digital, Cyber Attack On the NHS: Lessons Learned, NHS Report (2017)
[8] Information Technology Act, 2000, No. 21, Acts of Parliament, 2000 (India)
[9] General Data Protection Regulation, Regulation (EU) 2016/679
[10] Jane Roe, AI in Healthcare: Legal and Ethical Considerations, 44J. Med. Ethics 321 (2023)
[11] Byrne V. Avery Ctr. For Obstetrics & Gynecology, P.C., 314 Conn. 433, 102A.3d 32 (2014)
Disclaimer: The materials provided herein are intended solely for informational purposes. Accessing or using the site or the materials does not establish an attorney-client relationship. The information presented on this site is not to be construed as legal or professional advice, and it should not be relied upon for such purposes or used as a substitute for advice from a licensed attorney in your state. Additionally, the viewpoint presented by the author is personal.
0 Comments