Ads and commercials play a significant role in shaping human mind. Various health companies trick consumers to buy or subscribe to health programs or pills with no proved evidence. Often these cases go undetected, or the legal settlements take backlog due to lack of proper policy system in guiding health sector. With the advent of Digital Health Revolution, the gap has only widened over the years. In this article, we shall look into the importance of health policy in guiding digital health revolution and its effect on the marketplace in general.
What is health policy?
Technically, health policy refers to actions and decisions undertaken to achieve specific health care goals in the society by covering topics like finance, access to care, delivery of health care, health equity and quality of attention. Various categories of health policies are global health policy, public health policy, mental health policy, Not only it defines the future of health sector, but it also outlines expectations and requirements of various groups of the society.
Today’s health sector is with technology and gadgets. According to Pew survey, more than 64% Americans own a fitness tool. By 2016, there are more than 165,000 apps (according to IMS Health), and it is nowhere stopping. The Big Data Revolution has seen a careful recording of data like heart rate, the number of calories burnt, etc. Certain apps, in fact, help patients who have Alzheimer’s disease, heart conditions, Bipolar disorder, and depression.
This pressurized the legislators, who have to modify or strengthen their stance as the health sector bloomed to adopt digitalization and include Artificial Intelligence and Big Data into its work structure.
Who makes digital health policy?
Individual institutions like European Federation for Medical Informatics (EFMI) (assisted by WHO), Canada Health Infoway(in Canada, supported by Royal Commission on the Future of Health Care in Canada), AHRQ National Resource Center for Health Information Technology (in US), RTSS are few institutions responsible for monitoring digital healthcare policies. Department of Health primarily maintains them (e.g. Strategy, Implementation and Performance, Information and Transparency, Informatics Assurance), leading academics (e.g. UCL Computer Science, Epidemiology & Public Health, Human-Computer Interaction and Health Informatics) and Industry experts (e.g. Bupa, Microsoft, IBM, Innovate UK, the ICS, IMRG, Royal Bank of Scotland).
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Aspects of health policy
First, one needs to know what providers and stakeholders do with digital health.
- Reduce inefficiency in the present system using efficient, fast, and vastly accurate algorithms and data structuring.
- Improve access to the health sector to various niches, through digital means.
- Reduce cost of health facilities. One of the primary concerns of the developing world is the elevated prices of medicines and medical necessities.
- Raise the quality of services provided to the masses.
- It is possible to make medicine with a personal touch offered to patients.
So consumers in general use digital services like apps, smart phones, tracking machines to track changes or health related activities. Social networks and internet facilities vastly transform the outlook through which patients approach their wellness related solutions. They offer consumers innovative ways to monitor health, in addition to vast amounts of information. The advancements lead to convergence of thoughts, information, people, technology, and connectivity to improve clinical outcomes.
Stakeholders currently are involved in the following digital health activities:-
- Patient and health care
- Traditional medical health devices industry firms
- App developers
The legislators and FDA are currently working on following sectors of digital health:-
- Wireless Medical Devices
- Health IT
- Medical Device Data Systems
- Software as a Medical Device (SaMD)
- Medical Device Interoperability
- Mobile medical apps
- General Wellness
How do policies help digital health sector?
The policies help digital health sector in following ways:-
- By fostering collaborations and enhancing outreach to digital health customers.
- Developing and implementing regulatory strategies and policies for digital health technologies.
Let us explain in detail how they matter. An example of the fiasco with 23andMe is a good cautionary tale. When FDA dismissed the startup from selling its battery of saliva-based genetic tests to consumers, it shut down their primary business. They went into patch up mode and displayed themselves fully compliant with FDA rules. It slowly worked its way into FDA’s good graces, and the Association finally granted 23andMe to sell its direct-to-consumer test for Bloom Syndrome, a rare genetic condition. Later it announced that it would sell direct-to-consumer “carrier status” tests, in which users can determine their risk of passing 36 genetic diseases to their children.
The above incident had serious effects on companies in digital health space. Steve Krein, the CEO of StartUp Health went on to say, “It made everyone realize, ‘this is not a game, it has to be taken seriously, and you need to factor working with regulators into your resource plans and your timeline.”
FTC can take control of the situations well outside FDA’s jurisdiction where the unlawful or false claims are made, like Lumos or 23andMe. There are also laws about protecting patients’ medical records, which are necessary in case companies ask for personal details and claim false.
Why are health policies necessary for new start-up companies entering digital health sector?
Digital health startups are regulated by several bodies-FDA, the FTC, and the Health Insurance Portability and Accountability Act (HIPAA). The uncertainty in reach and extent often affects the funding. Startups are less likely to receive start up investment if they are allowed to explain how policies affect their companies. This often dissuades entrepreneurs from entering digital health space. The complex and seemingly lengthy clearance serves as a major hurdle to receiving enthusiastic young blood in these areas.
If given proper space, time and investment, Beihn says, “machine learning can unearth new areas, and the entire field shall be revolutionized. It just needs to be properly monitored.”
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