Over the course of eight weeks, we will be publishing a series of articles on the partnership between healthcare and technology and legal implications on key stakeholders in the health system.
This first article in the series provides an overview of the significance of technology in healthcare, with a focus on Thailand.
Technology in Healthcare: The New Face of Healthcare Delivery
Technology in healthcare or for healthcare is not new. It has been around for many years. When we talk about technology in healthcare it can mean many different things to different people. Terms such as Health Tech, Health Technology, MediTech, Medical Information Technology and Digital Health all refer to much the same thing, namely, the partnership between technology and healthcare and the healthcare industry. Any definitive definition of these terms is difficult. The possible uses of technology in healthcare are virtually limitless.
However, one thing is certain - the convergence of the healthcare and technology industries is resulting in a radical change in the delivery of healthcare services. In the course of the weeks to follow, we will attempt to provide an overview of key trends and address some of the issues that arise as a result of healthtech innovations that are changing the face of the healthcare industry. Some of these issues will include:
- Healthtech environment in Thailand – current situation and how the delivery of healthcare can benefit from technology
- Technology from a personal use perspective, including apps and wearables
- Technology from the health system perspective such as telemedicine and limitations of technology
- Data privacy and reclassification of products
- Potential legal liabilities of key stakeholders in the healthcare system
- Compliance, data protection and level of access to information
- Health insurance and malpractice
Before we continue, let's just make it clear that we are talking about more recent technologies, for example, digital innovations, immuno-oncology products, and enhanced diagnostic and active intervention devices and procedures to name just a few.
Development of science and technology has become ever faster and more effective with there being an ever increasing revolution and integration of the two. There is the potential to radically change our lives, the way in which we manage our health, and the way various stakeholders (whether it be ourselves as patients, industry operators such as medicine and device manufacturers, healthcare facility owners, governmental agencies and the general public). We can now use technology and science to prevent sickness and to maintain good health as opposed to merely focusing on the curing of diseases.
Like everything else technology comes with challenges. There are huge questions for all stakeholders to consider. How best to balance the benefit of technology and science without (i) compromising ethical and medical best practices of healthcare professionals and relevant personnel, (ii) privacy of patient, (iii) quality of healthcare treatment which we have been developed until now, (iv) the need to lower healthcare expenditure as a whole, and (v) the need to lower the gap of good quality medical treatments between the rich and the poor, to mention just a few.
With the level of development and increase of access to digital data and devices which is occurring in Thailand it is really important for various stakeholders to try to leverage the great potential of using this development to improve the national healthcare system and its infrastructure and delivery. Otherwise, Thailand will find itself running to catch up with higher technology in the future which will be far too costly (both in terms of economic cost and the wellbeing of the public) or at worst may not be possible at all. Any government which fails to use these new innovations may end up spending even more money in the future for national healthcare and risk being left behinds in terms of quality of life and ability to compete. It might sound hard to understand but imagine these possible scenarios:
- A time when in Thailand we continue to have physicians working in physical healthcare facilities whilst other countries surrounding us are providing telemedicine and treatments which allow people from remote areas to access good standards of treatment.
- Private medical and device companies move to provide products which aim to improve health and lifestyle rather than simply producing traditional medicines which we are currently depending on. The production of these medicines will likely become more expensive for countries which still need them since there will simply no longer be any economies of scale.
- When our neighboring countries improve their healthcare systems and infrastructure which accommodate new technology and digital innovation then where is the future for our dream of being a medical hub? We may end up producing (if we still can) best personnel for others and not for our own national fundamental healthcare needs.
- We cannot use "innovative" medicines to cure life threatening diseases as we don’t have a healthcare infrastructure in our hospitals which can accommodate them.
- Our great quality healthcare professionals (who cannot resist technical challenges and developments) move away to work in other countries, the crisis we used to (or perhaps still) have.
- Where will Thailand be in the next few decades when we become an aging society? How much of our national healthcare spending budget will have to be used in treating the poor health of old people who can no longer contribute to the national income. We have to imagine ourselves in the midst of countries with improving healthcare systems and infrastructure that are actually improving and maintaining their population in a more sustainable way by leveraging health technology and innovation.
Big questions for Thai stakeholders are as follows. Given the major and real challenges we are all now facing do we need to wake up quickly? Does it not matter that in spite of how hard, painful and expensive it may prove to be (and this is likely to be true for other countries as well with, developed ones not being an exception) we simply cannot afford to be left behind in terms of very fast moving technological innovation? Should we not be using the active digital usage of Thais as an advantage and transforming ourselves to be compatible and competitive with other countries?
If we fail to meet these challenges we might need to reclassify current medicine (which we now call modern medicine) and in the future call it "traditional medicine". This is not just a joke. Hopefully, it is a way of making us all aware of how bad things could be and ensuring we do something about it.
The Healthtech Environment in Thailand
In the first article of this series we gave an overview of the significance of technology in healthcare. We pointed out that although the partnership between technology and healthcare is not new what is new is the rate and scale of change, ranging from the use of digital devices through to new generations of immune-oncology drugs and enhanced diagnostic and active intervention therapies (to mention only a few). We suggested that Thailand needs to ensure it keeps pace with these developments otherwise it runs the risk of being left behind and becoming obsolete and uncompetitive.
In this article we will attempt to provide an brief overview of the current health technology environment in Thailand. From the outset it needs to emphasized the landscape is a mixed one. On the one hand the private sector and private hospitals appear to be in relatively robust good form. Some private Thai hospitals are winning international recognition and awards for being "electronically smart" by being at the cutting edge of adoption of new technologies. Numbers of medical tourists to Thailand continue to increase. Some 57 Thai hospitals have international accreditation from the Joint Commission International (JCI), a US based accreditation agency that scrutinizes hospitals to ensure they comply with international established best practice.
On the other hand the picture as far as the public sector and government hospitals is concerned is very different. A recent article in this newspaper focused on the "chronic" condition of state hospitals resulting from "doctors quitting due to excessive workloads and inefficient care" leading to long delays and even in some cases patient deaths. The article mentioned that there are around 18,000 doctors registered with the Public Health Ministry of whom only 57% work in state hospitals, including regional and community hospitals. The problem is compounded by the unequal distribution of doctors. The doctor patient ratio in Bangkok is 1-to-720. In the North it's 1-to-2,300 and in the North East 1-to-3,200. The turnover rate of doctors in state hospitals is higher than in private hospitals due to insufficient numbers of doctors "making it hard to cope with ever increasing patients".
In effect we have a two speed healthcare environment in Thailand, one in the private sector and another in the public sector. The problem is a familiar one. Doctors and other health care professionals are being encouraged to leave the public sector for better working conditions in the private sector. The growth of the private sector is being facilitated by gaps and deficiencies in the public sector. There is a non-virtuous cycle of cause and effect. Maybe there is an analogy with the proliferation of private schools in Thailand, the deficiencies in the state school sector feeding the growth in the private school sector?
The question arises on what can be done about rectifying this situation and what role might technology have to play? In no particular order or priority we offer some suggestions.
- The government has a "Thailand 4.0" project whose aim is to promote high-tech transformation. A committee has been tasked with pursuing 10 service reforms which include quicker approvals for pharmaceutical and health products. The PM's Office Minister is reported as having suggested bureaucratic reforms will firstly need to be implemented. With respect we agree with this suggestion. Digitalization will not be effective if it simply replicates existing bureaucratic processes and procedures into digital format. This is unlikely to be easy. Vested interest may have little incentive to change and may see innovation and change as threatening. Effective change is likely to require co-operation from the bottom up, and not simply be dictated top down. Thailand should leverage the enthusiasm and political support for high-tech transformation in the present climate to leap frog and lay down necessary infrastructure that would facilitate fundamental transformation rapidly and decisively, instead of incremental reforms.
- The potential for new technology to have an impact on healthcare should not be exaggerated. New technology will never be a substitute for good policy, good organization and good management. New technology by itself will not eradicate corruption or ensure there is a more fair and efficient procurement and allocation of resources. The prospect of new technologies should not be allowed to delay the implementation of improvements which can be achieved immediately. For example, in the case of state hospitals better management of existing resources and of how these resources can be more fairly and efficiently allocated in rural areas.
- Some learned commentators are suggesting that in the future traditional hospitals may become largely obsolete or at the very least confined to dealing with patients requiring urgent and serious interventions. Innovations such as telemedicine (which refers to the systematic provision of healthcare services over physically separate environments via an electronic network), video conferencing and robotics, combined with use of home and mobile-based devices, are predicted to enable many more people to access home care and avoid the need for hospitalization. It is said hospitals will become smaller and fewer. Healthcare in general will be more decentralized and egalitarian. It is said people prefer to be treated at home and that hospital managers need to appreciate this fact and be able to respond to this preference. However it remains to be seen whether these trends will come to fruition in Thailand or indeed elsewhere. What remains true is that predictions are not infrequently wrong. What is certain is that they should not be used as a pretext for not attending to deficiencies which are capable of rectification, given the current state of existing technology.
- It remains true that Thailand, Singapore and Malaysia continue to benefit from medical tourism and that they have emerged and continue to be leaders in the field. However a number of "inconvenient truths" may underpin this phenomenon. Poor medical infrastructure and substandard equipment in many emerging nations can leave patients with little option but to travel abroad for medical treatment (including to Thailand). Whilst governments may promise universal healthcare for their citizens the reality is that access can be poor. Thailand's own position in this respect is somewhat ambivalent. On the one hand its private hospitals can benefit from medical tourism whilst on the other hand its own citizens (especially those in rural areas) can suffer detriment and disadvantage.
- In our first article we mentioned Thailand's comparatively effective uptake of digital to date as being grounds for cautious optimism concerning its ability to harness the transformative potential of innovation and new technologies in healthcare in the future. This is and remains our view. However as will be apparent to readers of this article the actual outcome is by no means assured.
*The original article was published in The Bangkok Post on 29 August 2017
Mobile Health: Smart Device or Medical Device?
In the first two articles in this series, we provided brief overviews of the growing partnership between technology and healthcare and of the healthcare environment in Thailand. In this third article, we will discuss some of the products which have been innovated, developed, manufactured, assembled and brought to market by new generations of technology, such as the internet, social media, big data, enhanced computing power and information systems, wireless sensor, imaging (3D) and various other kinds of mobile connectivity. We will explore together whether this new breed of products will disrupt and/or promote healthcare delivery and services. Given the current healthcare environment in Thailand, an important question will be how best we can leverage these new products in order to break through or diminish some of the shortages and limitations we are currently facing.
When we talk about innovative products in healthcare, they can be separated into many different categories. To help our understanding, we will separate them into a few categories based on their users/usage, namely: (i) those which are used in labs and healthcare facilities without direct interaction or involvement with patients; (ii) those which are used or intended to be used by physicians or other healthcare professionals and require patient interaction, involvement or consent; and (iii) those that are used by patients without the involvement of doctors or other healthcare professionals.
Let’s now discuss something reasonably close to our daily life as an example. Wearables and smart devices and their applications are reasonably familiar to many of us. Health awareness, lifestyle and wellness trends help in promoting usage of these wearables and devices. They can collect data from users and that data is in real time. As most of these products do not intervene in and interact with the human body, as does a pharmaceutical, they may not always require the same level of close scrutiny and control as is exercised by the FDA in the case of pharmaceuticals. However, if the innovative product in question is, for example, the application of 3D printing to the manufacture of pharmaceuticals (what are sometimes called “3DP drugs”) then the same (or a substantially comparable) level of scrutiny and control may well be appropriate. Thus when considering any regulation of any innovative product that may be appropriate, we need to have due regard not just to the identity of the innovative product in question but also the purpose to which that product will be put. In terms of any regulatory supervision, the trick is to strike the right balance between ensuring proper standards of quality, efficacy and safety on the one hand whilst ensuring reasonable and affordable access and usage on the other.
When we start thinking about things in any depth, we can find that relevant issues that require consideration can be far more complex than we may have initially anticipated. With just one single product, there may be many issues and challenges. We need to know how to ask relevant questions and obtain accurate and informative answers if we are to derive maximum benefit and advantage from innovative products.
Returning to smart phone applications and wearable devices, these will allow patients access to their own personal health data/information. Benefits are obvious. The collection of information in digital form and its proper utilization can yield impressive results, in one study in one hospital a 51% reduction in adverse drug events. Mobile connections alone can help create awareness of diseases and help to mitigate the spread of the diseases.
Information and knowledge are usually empowering in most contexts and technology and healthcare are no exceptions. Enhanced information is of great importance in the delivery of more efficient and effective health care systems. Often driving this development have been advances in computer technology (from supercomputers such as IBM's Watson) through to micro-processors (on mobile applications), enabling and facilitating the collection, analysis, use and retention of a wide range of medical data.
It will be apparent from this brief overview that there are many relevant questions, a few of which are as follows:
i. Can any innovative products be considered to be “medical devices” under current legislation? If they can be, is it possible and practical (given limited healthcare budgets) for patients to obtain reimbursement under, say, any of the Universal Coverage Scheme, the Civil Servants Medical Benefits Scheme, or some private medical insurance? Secondly, who will be considered to be the "manufacturer" and "importer" (given the existence of multiple parties likely to be involved in the process of making innovative products operational, including manufacturers of hardware, software owners and those combining the two)?
ii. Who will be responsible if innovative products go wrong or cause injuries, loss or damage to users or third parties? Will it be the software developer, the hardware manufacturer, the importer (the list can go on and on)? More important than identifying the responsible party may be how practical the taking of any legal action or the enforcement of the legal finding against that party will be. (Generally speaking it needs to be understood that wearables are unlikely to be found to be “medical devices”, at least in many/most of their applications, therefore outside the control of regulatory authorities and perhaps suggestive of the need to ensure there is no overreliance upon them).
iii. If an innovative product is not considered to be “medical device”, the question may well then be who will nonetheless be responsible for controlling and monitoring usage and how practical will it be for any government authority to keep under review any change in usage, given the fast development of technology.
iv. Irrespective of whether or not an innovative product is considered a “medical device", it will be likely to be used for data collection and storage. Questions arise as to who will be allowed to manage and collect data? Will consumers and patients be considered to be giving an "implied" consent when they use the product or when they download relevant software? Are any prior disclaimers in any template terms and conditions for software supply and usage sufficient to protect the software provider and owner?
In the next article we will discuss issues surrounding the collection, storage, usage, privacy and legal implications of sensitive data management.
*The original article was published in The Bangkok Post on 4 September 2017
The Importance and Protection of Personal Health Information
In our previous article, we discussed some of the products which have been innovated, developed, manufactured, assembled and brought to market by new generations of technology and some of the opportunities and legal implications. Often these products enable and facilitate the collection, analysis, use and retention of a wide range of medical data. In this article, we will briefly discuss the importance and protection of personal health information (what is often referred to as "patient data" or "medical records") and legal implications of sensitive data management.
The expressions "personal health information", "patient data" or "medical records" refer to a wide spectrum of different types of information, everything from traditional medical records (kept by doctors in respect to their patients) through to human genome sequencing (providing a roadmap of the human body, analogous to understanding the computer code that controls our body, and promising the dawn of "personalised" or "precision" medicine).
This technology - driven enhancement of patient data has been marked in some parts of Thailand's private healthcare sector. One leading private hospital has been designated as among the world's electronically "smartest". It claims to have digitally integrated almost all of the services and activities conducted at its innovative facilities using secure wireless technology, including the replacement of all of its paper records with a digital system. The amount of patient information collected and collated has increased substantially, allowing clinicians improved patient access. It is said clinicians have more time with their patients, decision - making is more informed, medical outcomes are improved and errors reduced.
One of the key problems facing health delivery system in Thailand is the lack of integrated health data that allow patients to access their health information easily wherever they are. Having infrastructure that facilitate the exchange of Electronic Health Records (EHRs) will have the obvious benefits of improved healthcare quality and better patient care, reduced expenditure and increased access to high standards of healthcare, among other things. On the other hand, key considerations will be how to ensure data integrity and patient privacy. On this, there is a need for relevant laws to be harmonized and guidelines to be established to ensure appropriate patient data usage and identify which information is sensitive.
A committee on Public Health was appointed by the NLA a few years ago to review and assess present situation of the medical and information/data in Thailand and suggested actions to be taken so that data can be collected and utilized effectively for public health purposes. The study report recognizes the need to protect sensitive data of patients and possibility of amending certain provisions of the National Public Health Act so that they are consistent with the restrictions/protection of sensitive information under the Data Privacy Bill, the new law which is being drafted at the moment. Given this development, it seems having good platform and system to collect, store and effectively utilize the health data in more effective manner should be possible.
Some critical considerations and concerns when we talk about patient data usage include:
- Data protection and data protection laws
- Patient privacy
- Human errors
- System errors
- Unauthorized access
- Information overload
The need for confidentiality and the protection of patient data and privacy is self-evident. Many jurisdictions have enacted data protection and privacy laws which regulate the use and movement of personal data and information, both in healthcare contexts and elsewhere. Often these laws are complex and extensive. For example, in the EU one set of applicable laws includes some 88 pages of regulations. In the USA the Health Insurance Portability and Accountability Act (HIPAA) protects certain types of health information. HIPPA contains a "Privacy Rule" which seeks to strike a balance between the individual's concern to keep his/her health information confidential and other contrasting social considerations, including medical research. The Privacy Rule applies not only to health care providers but also researchers seeking access to or use of an individual's identifiable health information.
Parties who may be obliged to comply with data protection laws need to ask themselves a series of questions including the following:
- To what extent is personal data being collected (that is data that identifies individuals)?
- Is any of this data "sensitive"?
- For what purpose is the data collected?
- Are any consents required?
- Are there secure means to store and maintain both the confidentiality and permitted use of data?
- Will or may any of this data find its way offshore ( in which case there may be a need to ensure multi- jurisdictional compliance)?
Patient consent can raise complicated considerations. Is the consent full, free, fully informed, and comprehensive? For example, at the time of data collection it may not be possible to identify fully the subsequent research purposes to which personal data may be put. May there be a need to obtain a further consent? Is implied consent acceptable and to what extent?
Although the benefits of the availability of enhanced patient information are undoubted, may there be accompanying complications, extending beyond the need to comply with patient privacy and data protection laws. For example, on occasions there may simply be too much information available, rather than too little (information overload)? May there be instances where this information over load results in clinicians having to read and assimilate too much background information, having to spend too much time in doing so, and/or perhaps simply missing the wood for the trees? Is there a risk the right hand will not know what the left hand is doing and may there be a greater potential risk of miscommunication and/or misunderstanding?
If there is any validity in any of these queries, the situation may not improve. One estimate made in or around 2015 was that the rapid growth of data creation had resulted in some 90% of the data available at that time having been generated in the immediately preceding two years. If this trend continues, may there be a need for more effective supervision, discrimination and economy in the collection, dissemination and usage of patient information? Training will be of critical importance to ensure all parties involved avoid liabilities in data collection, storage and usage.
In the next article, we will discuss telemedicine and potential liabilities of parties involved in more detail.
*The original article was published in The Bangkok Post on 11 September 2017.
We are now moving to the second half of our series on healthcare. In the first four articles we provided an overview of the significance of technology in healthcare and how the partnership between technology and healthcare is evolving rapidly and fundamentally altering the nature of healthcare and the manner of its delivery. We suggested that Thailand needs to ensure it keeps pace with these changes or run the risk of being left behind.
In this article we will focus more closely on Telemedicine and consider some of the issues which may arise in relation to Telemedicine. The expression "Telemedicine" itself requires some explanation. There are different definitions of this expression which can vary from country to country. To add to the confusion alternative expressions may sometimes be used, including "e-health" and "telehealth." Notwithstanding these differences there are common underlying concepts including the delivery of healthcare services at a distance (that is, where the provider and the patient are not in close physical proximity with one another) and the use of information and communication technologies to do so. One definition is "the systematic provision of healthcare services over physically separate environments via information and communications technology (ICT)".
Telemedicine has become increasingly important and more in demand due to many factors including the following:
(i) A shortage of healthcare professionals, whether it be due to a real shortage in numbers or to the concentration of professionals in major cities.
(ii) Heightened consumer/patient expectations arising from innovations in technology.
(iii) Greater consumer/patient demand driven by life style choices and limitations, including traffic congestion.
(iv) Increased availability of cross border medical services.
(v) Changing demographics and unequal standards of healthcare in different locations.
What is apparent is that Telemedicine has the ability to help address and overcome gaps and deficiencies in existing healthcare systems (eg by making specialist services more readily available to those in remote rural areas). Technology can be leveraged to help overcome the many challenges facing the healthcare industry in general. Its potential cannot be ignored.
However, in many jurisdictions legal and ethical issues surrounding Telemedicine remain unclear and/or unresolved and in some instances controversial. There can be resistance to the successful adoption and implementation of Telemedicine at both provider and patient levels. Further complications can arise in the context of the cross-border provision of services. With a view to helping to resolve some of these issues certain jurisdictions have issued comprehensive guidelines, for example, the National Telemedicine Guidelines of Singapore.
Under the Singapore Guidelines healthcare professionals providing healthcare services by Telemedicine remain fully responsible for meeting all legal and ethical requirements and must exercise due diligence when delivering these services by Telemedicine. However, in other jurisdictions there can be resistance from healthcare professionals to assuming a duty of care in the case of Telemedicine. For example, in Thailand, the Medical Council of Thailand has expressed the view that a duty of care should only be established when there is an actual physical meeting between doctor and patient.
It does need to be appreciated that on occasions there may also be resistance from patients and potential patients. Some patients may not like the idea of receiving medical advice or treatment other than in a face to face meeting with a doctor, irrespective of considerations of access and convenience. Having said this it also appears consumer attitudes to Telemedicine or tele health may vary significantly in different countries. For example, in one US study it was reported that 70 per cent of patients were comfortable communicating with their health care providers via text, email or video rather than seeing them in person.
Maybe there is a need for Thailand to follow Singapore’s example and give serious consideration to the development of our own set of guidelines? Perhaps these guidelines could make it easier for both healthcare providers and patients to understand and accept the delivery of healthcare services through Telemedicine and help alleviate any concerns there may be. After all, none of us can hide from advances in technology. Perhaps the time has come to embrace fully Telemedicine and its benefits in Thailand?
If this is to be done effectively it is important to understand Telemedicine is complex and diverse and applies in a number of different situations and environments. The Singapore Guidelines identify four of them which are as follows:
- Tele-Treatment (at a distance interaction between a healthcare professional and a patient with direct clinical diagnosis, treatment and care).
- Tele-Collaboration (at a distance collaboration between healthcare professionals and distinguishable from Tele-Treatment in that health care professionals are involved at both ends of the communication e.g. specialty consultations).
- Tele-Monitoring (at a distance data collection from patients for monitoring and remote disease management).
- Tele-Support (use of on-line services for non-clinical support e.g. health education).
Responsibilities and standards of care may need to vary depending upon which of the four categories is involved. There should be no simplistic or "one size fits all" approach.
In our next article we will examine some of the implications of Telemedicine, including those in cross-border contexts and for healthcare professionals and hospitals/healthcare facilities involved with the provision of Telemedicine services.
*The original article was published in The Bangkok Post on 18 September 2017.
Telemedicine: Opportunities and Challenges
In our prior article we discussed Telemedicine, what it means, and how it has the potential to help solve many of the challenges confronting healthcare today. In Thailand, Telemedicine is relevant in both the public and private sectors. In the case of public hospitals it has the potential to provide improved access to healthcare services for people living in rural areas where there are insufficient doctors and facilities. In the case of the private sector it allows private hospitals in Thailand to be and remain competitive with international counterparts in medical tourism markets. However, in spite of this potential there are unresolved legal and ethical issues concerning Telemedicine. In this article we will discuss a few of them.
Duty of care
Other jurisdictions (for example, Singapore) provide that where there is a doctor patient relationship healthcare professionals providing services by Telemedicine ought to be responsible for meeting all applicable legal and ethical requirements and exercise due diligence in delivering such services.
It appears this may be a bridge too far for the Medical Council of Thailand. The Medical Council's current approach appears to be that a duty of care should only arise if and when there has been an actual physical meeting between doctor and patient. The question arises, is this attitude too rigid and inflexible? Whilst acknowledging that the ideal position may be a traditional face-to face meeting (where practical) does this approach, nonetheless, fall short in that it has insufficient regard to the reality that Telemedicine can be used as an effective tool to overcome obstacles (particularly of accessibility)?
We suggest a more flexible and up to date approach might have regard to the following (which are reflected in Singapore's Telemedicine Guidelines):
(a) To deliver quality care by Telemedicine a range of issues needs to be addressed including appropriate protocols, informed patient consent, privacy/confidentiality, adequate records and documentation, and appropriate facilities.
(b) Any service contemplated must be suitable and appropriate for delivery by Telemedicine. Delivery of the care in question by Telemedicine must be reasonable. What is reasonable must be determined having due regard to clinical objectives, the particular clinical context, and the availability and compatibility of technology to satisfy these objectives.
(c) Telemedicine arises in diverse contexts. There will be no single "one size fit all" approach. For example, the relevant standard of care may vary depending upon whether the Telemedicine interaction in question involves a patient at one end and a health care professional at the other end or is only between healthcare professionals at both ends.
(d) The provider must be satisfied that the patient is suitable for a Telemedicine interaction and is sufficiently literate to give a fully informed consent.
(e) Where a face-to-face consultation is not reasonably practicable it ought to be possible and permissible to deliver care via Telemedicine, recognizing that care via Telemedicine is preferable to no care at all.
(f) Before any telemedicine transaction occurs the respective responsibilities of the parties concerned ought to have been clearly established and be understood by all concerned.
If these propositions were to be adopted, it seems to us they could result in a more balanced and up to date approach to the question of what should be the appropriate duty of care applicable to Telemedicine services. In reality we anticipate that it is likely some private hospitals in Thailand have already moved to adopt a Singapore-type standard, in response to the expectations of their international patients and the approach of their international competitors.
Licensing and Accreditation Requirements
Especially in the context of cross-border and international transactions involving Telemedicine, issues of licensing and accreditation arise. Are the healthcare professionals involved in a particular international transaction in compliance with applicable laws and requirements? Are they registered and licensed to provide the service in question? Are they properly qualified and competent to do so?
Answers to these questions require a due and proper consideration of relevant laws and requirements at both ends of a transaction, both in the jurisdiction of the provider and at the other end of a transaction, in that of the patient. They may involve not just a consideration of the personnel involved but also the suitability of facilities and equipment in compliance with quality standards mandated by law or international best practice. In some instances there may be no clear cut answers. Given the potential for severe sanctions and damage to reputation a conservative and cautious stance may be required. Equally serious may be adverse implications concerning the availability of medical professional liability insurance.
We suggest observance of the following:
- Healthcare professionals providing Telemedicine services from Thailand to patients resident in other countries ought to be appropriately licensed in Thailand. They should also comply with any applicable licensing requirements in the patient's own country. Preferably services ought to be provided in collaboration with a healthcare provider licensed in the patient's own country.
- Healthcare professionals in Thailand intending to supervise or collaborate with an overseas provider to provide services to a patient residing in Thailand should observe the same standards as they are obliged to observe when treating a resident of Thailand.
- In sum, healthcare professionals delivering clinical services through Telemedicine ought to comply with the same requirements and standards as would be applicable if the services in question were delivered otherwise than through the use of Telemedicine.
Patient Privacy, Confidentiality and Data Protection
Providers need to ensure that in utilizing Telemedicine transactions there is compliance with applicable laws concerning medical records and patient privacy at both ends of a transaction, especially where the provider and the patient are resident in different jurisdictions.
Given the potential for vast amounts of personal and sensitive health information to be transferred using telecommunications technology the question arises whether internet service provider (ISP) companies may face increased scrutiny and perhaps even some level of regulatory oversight as providers of therapeutic services.
In any event clinicians will face the challenge of ensuring that the increased numbers of people having access to patient records and sensitive information duly observe protocols and ensure maintain the integrity of data and images transmitted in the course of Telemedicine transactions.
In the next article we will discuss the impact of Telemedicine on medical professional liability insurance (MPL insurance), a matter understandably near and dear to the hearts and minds of all doctors and other healthcare professionals.
*The original article was published in The Bangkok Post on 25 September 2017.
Telemedicine and Medical Professional Liability Risks
In our previous article, we discussed some of the legal and ethical issues concerning Telemedicine. In this article we will discuss some of the potential liability risks that may arise for doctors and other healthcare professionals when involved with Telemedicine. We will make some suggestions concerning practical steps that can be taken to contain risks and matters to be aware of when organizing medical professional liability (MPL) insurance. The focus in this article will be upon international Telemedicine, that is, Telemedicine transactions that cross the boundaries of different countries. In a Thai context this could include doctors in Thailand providing healthcare services by Telemedicine to patients situated in neighbouring countries, a not uncommon situation given Thailand's comparatively advanced healthcare infrastructure.
Telemedicine can be an invaluable tool that overcomes problems of accessibility. It can also be used for other purposes, for example, to take advantage of different time zones. One example we know of is a collaboration between radiologists in Sweden and Australia, referring images to one another for rapid assessment during each country's different working hours.
Providers of health care services in international contexts need to ensure that they have an adequate appreciation of potential risks and take prudent steps to manage these risks. In our prior article we emphasized the importance of providers ensuring that there is due compliance with licensing and accreditation requirements at both ends of a international Telemedicine transaction. This will be particularly so when there is a direct patient/provider relationship with the patient residing in a different country from the provider.
The Need for MPL Insurance
Providers should ensure that they have adequate and effective professional indemnity insurance. Compliance with licensing requirements is especially important when it comes to MPL insurance. It is not uncommon for insurers to exclude cover if medical treatment is rendered by a provider who is not duly licensed to provide that treatment in the jurisdiction where the service occurs. Conceivably there may even be issues of criminality involved in those jurisdictions which make it a criminal offence to practice medicine without appropriate licensing.
Thus providers need to be constantly aware of the risk that in providing a health care service by Telemedicine they may inadvertently be involving themselves in a violation of another country's healthcare laws and policies. Providers need to ensure that they fully understand and comply with the registration and licensing laws of any and all countries where they are providing Telemedicine services and that they are properly covered by their MPL insurance.
In some jurisdictions this problem has been alleviated by mutual recognition arrangements. For example, in the EU a physician duly registered in his/her home state can provide virtual care services to patients in another member state even if that physician is not registered in the member state in which the patient is located. In the case of Australia and New Zealand there is mutual recognition permitting physicians to practice in each jurisdiction.
We will now move on to discuss MPL insurance in a little more detail.
Types of MPL Insurance
There are two types of MPL insurance with two different types of cover. One of these is "occurrence" cover, the other "claims made" cover. It is important to have a full appreciation of the differences between these two types of cover and the timing differences between the two. Claims made cover is now the most common form of MPL insurance available. Occurrence cover is increasingly difficult to obtain although some insurers may still offer both but with occurrence cover limited to a few stipulated specialities. All of this can cause confusion. Insurers may use the composite expression "professional indemnity" in respect to both types of cover when in reality they cover different things and operate in different ways.
Under occurrence cover the insured will be protected from any covered incident which actually occurs during the policy period regardless of when a claim in relation to that incident arises. An occurrence policy will respond to a claim even after the policy in question has expired so long as the covered incident occurred during a period in which the policy was in force. Occurrence cover can provide what in effect is enduring cover for incidents that occurred during a policy period.
Claims Made Cover
Under claims made cover the insured will be covered for claims arising and notified to the insurer during the policy period. If a retroactive date is applicable the alleged incident giving rise to the claim must have taken place on or after that retroactive date. Depending upon any applicable retroactive date this may mean a claim made under a current policy might provide cover in respect to claims arising out of services performed in prior years. Once a policy expires cover also expires unless the policy is renewed. This is the situation even if a claim is subsequently made that relates back to an incident that occurred whilst the policy was in effect.
From this brief discussion it will be apparent issues arising for consideration in relation to MPL insurance can raise complex questions. It may well be desirable to seek expert advice from suitably qualified insurance brokers or other professionals. Particular care will be required when contemplating a change of insurer or a move from occurrence cover to claims made cover.
To date, and in spite of some dire predictions to the contrary, it appears the overall incidence of medical malpractice claims arising out of the use of Telemedicine has not markedly increased. Whether this remains the case in the future remains to be seen. Some are predicting an increase in malpractice allegations concerning the use of Telemedicine, especially in the context of high severity cases with a higher incidence of negative patient outcomes, such as cardiovascular, oncology and chronic disease management.
*The original article was published in The Bangkok Post on 2 October 2017.
Innovation and the Pharmaceutical Industry
In this series of articles, we have been discussing various aspects of innovation in healthcare and how advances in technology have been transforming healthcare. We have discussed how innovations in computer and communications technology have transformed the landscape of healthcare. However, one thing we have not yet discussed is the role of the pharmaceutical industry, the importance of drugs in the context of healthcare, and the significance of innovation in this industry.
Drugs play a pivotal role in our everyday lives and in the provision of healthcare across a very wide spectrum of diseases and ailments, everything from medicines for the treatment of a common cold or a headache through to antibiotics, therapies for cardiovascular, cancer, central nervous system, respiratory disorders, and virtually anything and everything else. We take drugs and their availability for granted. They provide cures for millions, avoid the need for visits to doctors and hospitals, and provide relief from pain and suffering. It is no exaggeration to say that some of the greatest innovations of the 20th century were advances in pharmacology, from anaesthesia to antibiotics and everything in between.
The pharmaceutical industry is international, knowledge-based, capital intensive, highly regulated and high risk/high reward. Continuous innovation is one of its most defining characteristics. Investment on research and development (R&D) probably exceeds that of any other industry.
New drug development is extremely difficult and risky, characterized by uncertainty of success, expense and long lead times. The human body is complex and variable. The effectiveness of drugs requires them to interact with the body. How an individual will react to a particular drug is unpredictable. The odds in favour of finding a new drug are miniscule. Only one in more than 5,000 compounds investigated ultimately becomes an approved drug. Typically about 30% of candidates fail because of associated toxicity, another 30% from lack of efficacy, and the remaining 30% or so due to a range of factors including rate of action, duration of effect, and problems with things such a absorption, metabolism or excretion.
The industry is subject to constant public scrutiny and quite frequently receives critical and unflattering commentary from sections of the media and others. Commentary is not always fair or balanced. Sometimes it is simply wrong and misinformed. Perceptions of the industry can change quickly. Several years ago it was fashionable to point to "patent cliffs" and empty product "pipelines" with dire warnings and predictions concerning the demise of the industry. How things have changed! Currently the industry has a wealth of new drugs under development. We will discuss a few of these and some of the digital innovations which are impacting on the industry.
Cancer immunotherapy (also called immunoncology or I-O) is one of the most significant breakthroughs in cancer therapy achieved for many years. The objective of I-O is to stimulate the body's immune system to identify and attack tumour cells. It is an innovative therapeutic tool that adds to the traditional means of treating cancer such as surgery, radiation and chemotherapy. Harnessing the immune system to fight cancer was contemplated for decades but remained elusive and extremely difficult. Today it is one of the most promising advances in the treatment of that intractable spectrum of diseases collectively called "cancer". A number of companies are racing to develop many new I-O drugs for a wide range of cancers and finding existing I-O drugs which are efficacious for additional cancers.
Genome Sequencing and Precision Medicine
On an individual patient level genome sequencing (a process which converts DNA into data) can be used to identify specific gene abnormalities (biomarkers) in individual patients. Identification of biomarkers can be used as a basis to assist in understanding for which types of patient a drug will be most effective and to minimize any side effects. These so-called "targeted therapies" or "precision medicine" involve the use of genomic testing to tailor make drugs suitable for the genetic make-up of the individual patients heralding a era of "personalized medicine". The relationship between an individual patient's genes and a particular drug can assist doctors in identifying the right drug and dosage for that patient, leading to improved outcomes and fewer side effects.
Computers with learning capabilities (such as IBM's Watson) can assimilate, interpret and cross-reference vast amounts of data and thereby assist the industry in its pursuit of new drugs and additional indications for existing drugs. Watson has demonstrated an ability to discover previously unknown or undetected connections between diseases and to make recommendations. Within minutes, Watson can scan and assess millions of pages of text in journals, clinical trials and medical records.
This microscopic technology uses nanoparticles to travel inside the human body and blood stream assisting with things such as the delivery and absorption of drugs and the monitoring of patient adherence.
3D printed drugs could change not only the way in which drugs are manufactured but also their administration. For example, in the future hospitals may be able to make slight adjustments to software before printing and thereby adjust dosages for individual patients, a process of personalisation that might otherwise be too expensive. The FDA has already approved a 3D printed drug that is made by creating layers on top of one another until the correct dosage is achieved.
The above mentioned are only a few examples of how the industry innovates and continues to innovate. The industry attracts more than its fair share of critics and pundits, including those who say it is not adapting to the "digital revolution" quickly enough nor accepting the inevitability of "digital disruption". In fact we believe the industry is very conscious of the potential of digital technology. However the reality is and remains that digital technology does not of itself produce new drugs. Digital technology is a valuable tool but only one of many. Successful drug innovation depends on many factors including state of the art life science, cutting-edge advancements in information optimization, discipline, persistence, good management and not a little old fashioned good luck, to name but a few of them.
We have sought to emphasize the fact that neither we nor Thailand as a whole can hide from technology and advances in technology. We all need to work together and welcome innovation and change. Adaptation and disruption can be positive experiences. Thailand's healthcare system has to find the right balance between cost effectiveness, quality, efficiency and accessibility. In the longer term an emphasis upon cost containment only is unlikely to provide an optimal solution.
*The original article was published in The Bangkok Post on 9 October 2017.