POWERING THE FUTURE OF HEALTHCARE AND REGULATION OF INNOVATIVE DEVICES

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 that have been innovated, developed, manufactured, assembled and brought to market based on new technology, such as the internet, social media, big data, enhanced computing power and information systems, wireless sensors, imaging (3D) and various kinds of mobile connectivity. We will explore whether this new breed of products will disrupt and/or promote healthcare delivery and services.

Given the current healthcare environment in Thailand, we need to ask how best we can leverage these new products in order to overcome or minimise 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 and usage, namely:

those used in labs and healthcare facilities without direct interaction or involvement with patients;

those used or intended to be used by physicians or other healthcare professionals and requiring patient interaction, involvement or consent; and

those used by patients without the involvement of doctors or other healthcare professionals.

Let’s now discuss something close to our daily life as an example. Most of us are familiar with wearables and smart devices and their applications. Health awareness, lifestyle and wellness trends have helped to promote usage of these devices, which can collect real-time data from users.

As most of these products do not intervene in and interact with the human body in the way that a drug does, these devices may not always require the same level of close scrutiny and control as is exercised by the Food and Drug Administration (FDA) in the case of pharmaceuticals.

However, if the innovation in question is, for example, the application of 3D printing to the manufacture of pharmaceuticals (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 consider not just to the identity of the product in question but also the purpose to which it 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 while ensuring reasonable and affordable access and usage on the other.

The more deeply we consider such issues, the more complex they can become. With just one single product there may be many issues and challenges. We need to know how to ask the relevant questions and obtain accurate and informative answers if we are to derive maximum benefit and advantage from innovative products.

Returning to smartphone applications and wearable devices, these will allow patients access to their own personal health data. The benefits are obvious. The collection of information in digital form and its proper utilisation can yield impressive results: for example, a study in one hospital showed a 51% reduction in adverse drug events. Mobile connections alone can help create awareness of diseases and help to mitigate their spread.

Information and knowledge are 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 healthcare systems. Often driving this development are advances in computer technology, from supercomputers through to microprocessors (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, among them:

1. 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, the Universal Coverage scheme, the Civil Servants’ Medical Benefits scheme, or some private medical insurance? Secondly, who will be considered the “manufacturer” and “importer” (given the existence of multiple parties likely to be involved in the process of making products operational, including manufacturers of hardware, software owners, and those combining the two)?

2. 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 it would be to take legal action or enforce a legal finding against that party. Generally speaking, wearables are unlikely to be considered “medical devices”, at least in many of their applications, and therefore outside the control of regulatory authorities. Perhaps this suggests the need to ensure there is no overreliance on them.

3. If an innovative product is not considered to be a “medical device”, who will nonetheless be responsible for controlling and monitoring its usage and how practical will it be for any government authority to be frequently reviewing changes in usage, given the fast development of technology?

4. Irrespective of whether or not an innovative product is considered a “medical device”, it is likely to be used for data collection and storage. Who will be allowed to manage and collect data? Will consumers and patients be considered as giving “implied” consent when they use the product or when they download the 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.

Peerapan Tungsuwan is a partner and head of the healthcare industry group at Baker McKenzie in Bangkok.