Digital Health Adoption Challenges

During the COVID-19 pandemic, the inclusion of telehealth services shone a spotlight on the use of emerging technology in healthcare. Telehealth systems have linked patients and physicians remotely, but the rise of telehealth has overshadowed a wider trend that has already been underway for some time: the use of digital health to transform treatment. There should be no doubt about the pandemic’s disruptive effect and the rush to digitize that it has ignited. But as with all rushes, there will be winners and losers, successes, and errors.

COVID-19 has moved digital health forward, but there exist areas that still face challenges

At the HIMSS & Health 2.0 European Conference, experts discussed the impact of digital technologies on the COVID-19 responses in Europe and some existing challenges in pushing digital health further. Some challenges were noted by Dr. Pravene Nath, MD, Global Head, Digital Health Strategy, Personalized Health Care, Roche, US, especially in the areas of access and administration, operations, and personalization.

  • Telehealth has been common in terms of access and administration over a short period, but it is still very uneven in terms of addressing all communities and the real smooth experience required to minimize uncertainty at a time when there is a limited supply
  • In operations, he said that demand forecasting, supply chain management, capacity management, and technology are important and ready for that. If these technological tools can be distributed to healthcare providers, they can make tactical decisions with real data in real-time
  • Finally, Dr. Nath noted that there is still some way to go in digitally activated, condition-focused (personalized) care, such as remote patient monitoring when combined with a care delivery model that enables moving beyondthe encounter

Hospitals are behind the digital health adoption curve

According to new research from Unisys Corporation, close to two-thirds of healthcare providers rate themselves as being behind the curve on their digital health implementation initiatives. HIMSS surveyed 220 health IT decision-makers/influencers in U.S. hospitals and health systems on behalf of Unisys and asked them to rate their company based on how they utilize digital and mobile technology to enhance patient service, lower the cost of delivering treatment and increase the performance of clinicians/staff. Then they were ranked as ahead of the curve (early adopters/early majority) or behind the curve (late majority/laggards).

Survey results found that 64%rated themselves as being behind the curve, including 20% who were rated as laggards. Notably, when it came to new technology adoption and deployment, only 11% of organizations were rated as early adopters.

Four obstacles to digital health adoption in hospital & health systems

Behind the curve, respondents cited digital health adoption challenges when asked about the obstacles to advancing digital health initiatives:

  1. Resistance of the clinician in introducing new solutions (51%)
  2. Difficulties with combining legacy systems with modern digital/mobile technologies (50%)
  3. Availability of experienced IT personnel (48%)
  4. Cybersecurity hazard identification/remedialization (45%)

Some potential challenges associated with the rapid, mass adoption of digital healthcare technology are:-

  1. The limitations of remote care

Another revealing statistic to come out of the pandemic is that there was reported to be a 42% drop in Attendances and Emergency (A&E) attendances in May 2020 as compared to May 2019 (according to NHS performance summary report Apr-May 2020). There are likely a multitude of reasons for this, including less trauma because of, for example, significantly reduced vehicle use and less contact sports being played, as well as less (non-COVID) illness and disease circulating in the community because of reduced societal contacts. However, there is undoubtedly a cohort of people who will have been too frightened to attend A&E and who may be finding other ways of getting treated without going to hospital, for example via video consultations with their GP.

  1. Digital Exclusion

Also, those that are most likely to encounter chronic health conditions such as diabetes, cardiopulmonary disease, hypertension, obesity, as well as poor mental health are the same groups who are least likely to interact with digital healthcare. For such groups, the rush to digital may well worsen health inequality and increased isolation as a visit to the GP becomes more difficult, if not impossible.

  1. Commercialising Data

Although patients may be prepared to support the use and promotion of anonymized health data for the good of a larger community, the use of data, which is lacking in accountability and intended to advance corporate interests and shareholder returns, may be less accommodating for them. The potential for their data to be exploited by insurance providers or in cases where it could result in other types of data-driven discrimination is another Red Line issue for patients.

  1. Data driven discrimination

Some may presume that grubby human bias would inherently be more impartial and less likely to tarnish the algorithms and machine learning that underpin many digital health solutions. That however may not be the case. Broadly speaking, algorithms are nothing more than encoded procedures or instructions, but it is knowledge that is the basis of all and information can discriminate just as much as individuals because, for instance, it is incomplete, poorly chosen, unrepresentative, obsolete, or just plain wrong and algorithms can also perpetuate prejudices.

  1. Legal liability

What happens when a decision is made or alerted by AI that causes patient damage, is a pertinent problem for digital health. In the end, where does liability for unintended harm lie? Should those who supply or curate the data sets on which the AI depends be held responsible or those who construct and code the AI; those who validate it; those who run it; or those clinicians whose decisions are supported by it?

The way health services are delivered and consumed has been altered through digital health, and COVID-19 has accentuated some of the benefits and possibilities of innovation in this sector.Yet these new healthcare delivery media present new problems, risks, and threats that cut to the very root of who we are as individuals and communities, and itwould be wise not to lose sight of some of the constraints of digital care, and the need to take everyone along on this journey.



FDA Launches the Digital Health Center of Excellence

The Digital Health Center of Excellence (DHCoE) has recently been launched by the US Food and Drug Administration (FDA), strengthening the digital change that the healthcare industry has already embraced.

In the future, within the Center for Devices and Radiological Health (CDRH) of the department, the program will serve as a coordination platform to help with relevant regulatory activities and to provide the FDA as a whole with digital health policy expertise.

As the new center’s first director, the agency named Bakul Patel, who has helped lead the FDA’s regulatory and scientific efforts covering digital health devices since 2010.

The DHCoE is tasked with providing expertise to help accelerate access to digital health tools that are secure and reliable. In this sense, the Digital Health Center of Excellence is building a network of digital health practitioners and is participating in Collaborative Communities to share expertise and experience with FDA workers on digital health issues and goals.

Despite strong overtures in this market, digital health continues to face major challenges, including data consistency, assessment of the reliability of treatment outcomes, and issues of integration between innovative parties.

In digital health exploration, the DHCoE is a much-needed catalyst and aims to overcome these challenges by reducing risk and connecting the innovation dots across the digital health space that encompasses consumer health and wellness wearables, digital health technology, mobile health technology, medical device software (SaMD), and medical product testing technologies.

In addition to providing technical guidance, organizing and encouraging work across the FDA, advancing best practices, and reimagining digital health device oversight, DHCoE’s goal is to enable both internal and external stakeholders to advance health care by facilitating responsible and high-quality digital health innovation.

The Digital Health Center of Excellence has the following objectives:

  • Connect and build alliances to drive developments in digital health
  • Connect and build partnerships to accelerate digital health advancements
  • Share knowledge to increase understanding and awareness, drive synergy, and encourage best practices
  • Innovate regulatory approachesto provide efficient and least burdensome oversight while meeting the FDA standards for safe and effective products

The FDA anticipates the following developments in digital health by achieving the above objectives:-

  • Strategically advance science and evidence for digital health technologies that meetS the needs of stakeholders
  • Efficient access to highly specialized expertise, knowledge, and tools to accelerate access to digital health technology
  • Aligned regulatory approach to harmonize international regulatory expectations and industry standards
  • Increased awareness and understanding of digital health trends
  • Consistent application of digital health technology policy and oversight approaches
  • Reimagined medical device regulatory paradigm tailored for digital health technologies

Since the beginning of the Covid-19 pandemic, the FDA has also taken steps to expand access to digital health resources. For example, the agency temporarily waived certain limitations on the use of software tools for mental health, allowing low-risk digital health products to be sold without a 510(k) premarket warning to the public. But certain quality controls, including software testing and cybersecurity standards, also had to be satisfied.

As part of an effort to modernize digital health policies and regulatory approaches and provide efficient access to highly specialized expertise, information, and resources to accelerate access to secure and effective digital health technologies, the FDA will continue to develop and formalize the organizing framework and operations of the Digital Health Center of Excellence.