As health systems grapple with the aftermath of Covid, many are exploring the possibilities of digital health solutions. Not only do these technologies make sense for organizations in the long term, but the demand for telehealth is high. Provider shortages and burnout continue to plague many areas of the U.S., and increasing use of digital health tools has made them a hot topic. But how can healthcare systems evaluate these new solutions and ensure that they deliver optimal results?
The current process of assessment involves a number of steps. First, companies and governments need to assess their solutions based on the metrics and quality assurance that they provide. A comprehensive model should be created that balances cost and innovation. It is critical that the standards and metrics used to assess digital health solutions are rigorous. This can be challenging, especially in a rapidly changing field like digital health. Fortunately, there are now a variety of methods that can help healthcare systems determine if a new solution is adequate and worth the investment.
Second, the digital health solution should be flexible and allow users to use various methods of communication. It should be compatible with various frequency bands and modes of interaction. Lastly, it should allow users to customize their experience. Users should be able to choose the type of information they want to receive and share. This is critical for gaining wide adoption. While this might not seem like a big deal, it should be considered before implementing any digital health solution.
Third, innovators should determine their company type. Life science companies have different regulatory requirements than technology companies, and they offer solutions that directly affect patients and physicians. Whether a digital health company is a medical device, app, or service provider, it is important to understand the differences between these two categories. Whether an innovator is working within a traditional health care organization or a start-up, the approach to digital health must be flexible and focused.
In the United States, clinical trials are the gold standard for healthcare assessment, but DTx companies also need to meet certain standards to ensure their solutions are safe and effective. For instance, a digital health solution must comply with the Health Information Technology Act (HIPAA) and the Privacy Shield Act. In the European Union, it should also be compliant with the General Data Protection Regulation (GDPR) – which states that privacy regulations and personal health data are protected and secure.
In Germany, DTx companies have a year to collect evidence before they can be included in the assessment. Over three-quarters of companies that enter the assessment process choose this option. However, the evaluation process for digital health solutions is more difficult, as the benefits may be distributed across several sectors. Thus, if a company develops a solution for a disease or disorder that spans a number of sectors, it may have a harder time selling.
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