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Digital health has made a range of technologies from genome sequencing to smartphone-connected ECG readily available, although it also carries the risk of dehumanizing care. Advances in technology along with widespread access by patients mean that there is a growing demand that policies keep pace with this rapidly changing dynamic in the healthcare environment.

Policy makers are expected to make every new technology available quickly, otherwise consumers start using those without regulations. This is an unprecedented time pressure as technologies are becoming available at an increasing rate.

It comes with risks too. Medical technologies including surgical robots, pacemakers and insulin pumps have been shown to be prone to hacking. Health sensors used by patients at home might not be accurate and lack evidence-based background. Patients might find misleading information online that leads to false self-diagnosis. Shared decision-making has an obvious problem too: who is responsible for the individual decisions?

Companies providing direct-to-consumer genetic tests, ECG measurements and other analyses might sell their data to third parties without their users’ consent. Digital health technologies can also increase the risk of bioterrorism. These are the challenges we already know about and there are many others we can anticipate.

Soon, chatbots could answer basic medical questions at home; 3D printed biomaterials might be used to replace organ transplantations in certain conditions; drones could deliver blood supplies; Amazon could sell prescription drugs and the ultimate technology, artificial intelligence could take over plenty of repetitive elements, diagnostic decisions and data analytics in a physician’s job.

The expected outcome of the work of policy makers in all these is diverse:

  1. To help promote the safe use of digital health technologies
  2. To regulate new technologies as fast as possible
  3. To keep healthcare technologies and patients’ data safe

While issues vary over countries, regions and specialties; there are great examples worldwide that could serve as an ammunition for ideas. Not all digital health technology is created equal. A smartphone app for counting calories is not the same as using a direct-to-consumer genetic service. Regulators are therefore trying to figure out the new paradigm on the go. This report provides a running list of such examples in the coming chapters.

Some of the best practices and important milestones we collected might be specific to a region, healthcare system or technology, but this list was meant to give a clear picture about how policy makers worldwide deal with digital health and hopefully serve as an inspiration that will spark new ideas and even better ways of regulation.

We divided the examples into 4 categories:

  1. Patient Centricity
  2. Regulating Disruptive Technologies
  3. Preventing Ethical Challenges
  4. Promoting The Use Of Digital Health


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