“Don’t rush to use unverified digital health products”


The Covid-19 pandemic has advanced the era of digital health care, but the medical community should have a critical perspective to verify the potential and real effect of digital health, an expert has said.

Harlan Krumholz, director of the Center for Outcomes Research and Evaluation (CORE) at Yale University, discussed the role of the medical community in the introduction of digital health products during the session “Next Normal & Digital Healthcare in the Post-COVID-19 Era” at Korea Healthcare Congress 2021, hosted by the Korea Hospital Association on Thursday.

Harlan Krumholz, director of the Center for Outcomes Research and Evaluation (CORE) at Yale University, said doctors shouldn’t be rushed to use digital health products at Korea Healthcare Congress 2021 on Thursday. (Credit: KHC 2021 Online Session Video Clip)

Quoting a Korean idiom, “don’t drink the kimchi soup first,” Krumholz said doctors shouldn’t hastily change treatment methods until they can see digital products prove their ability to improve treatment.

“Digital health technologies are certainly needed, but simply having technologies does not guarantee improved clinical intervention outcomes,” he said.

With growing interest in digital health in the wake of Covid-19, the US government has revised its policies to promote telehealth. The FDA has developed criteria for evaluating software as medical devices (SaMD).

However, not all digital health products are subject to regulation or verification, and the lack of data for verification makes it difficult to confirm the effect of digital health products, Krumholz said.

Data used for analysis and clinical validation is not disclosed, whether regulated or not, he continued. Even if the data is controlled, essential information such as whether the clinical trial was conducted on all populations is often missing, he said.

Krumholz predicted that publication bias, only to publish results that show a favorable conclusion, would occur more frequently in the digital health sector.

A five-year investigation found that a study supported by the US National Institutes of Health omitted a third of the results due to publication bias, he said.

Clinical studies testing products remotely may run into the problem of participants leaving the designated site in the middle of the study. If researchers draw results from the few remaining participants at the end of the trial, there is a risk that the results will be biased.

Even when doctors directly encourage patients to participate in clinical trials, about half of them only use the product for about a month, Krumholz said. “We should improve the criteria so that we can examine and evaluate the product under real conditions,” he said.

Krumholz proposed creating an innovative ecosystem that forces digital health companies to be accountable for the effect of their products. He said the starting point would be to ask a fundamental question about what the patient gets out of using the product.

“If physicians are influenced by the rise of digital health products and market trends, they might choose a product that is unnecessary or even harmful. They should address this fundamentally,” Krumholz said. When evaluating products, physicians should ask if the patient’s life has improved, if the survival rate, quality of life and cost of care have improved, if the patient has had the opportunity to achieve health goals and whether the patient’s preferences and values ​​have been respected. , he added.

He also called for caution against unexpected side effects of digital health products.

He said each intervention must assess the possibility of causing unexpected adverse effects. There is always a possibility of erroneous results on a modified system, even with good intentions.

“Physicians should focus not only on the expected benefits, but also on the potential for harm. The harm may be greater than the expected benefit,” he said.

Finally, he said the medical community should reward the best treatment outcomes, not the seller, in an age of great promise in digital health. “The medical community should have a critical view of the entire product lifecycle and demand evidence,” he added.


About Author

Comments are closed.