Disruption In Healthcare Could Be Costly

Entrepreneurs are giving the healthcare industry a much-needed injection of innovation. Enthusiasm for new ideas and solutions in healthcare is clear from the 200 percent growth in funding for digital health companies between 2010 and 2014.

Digital health companies received a record-breaking $4.1 billion in funding in 2014, and more than $600 million in the first quarter of 2015. Many innovators have dramatically changed the healthcare landscape with solutions that are making patient care less expensive and more accessible, integrated and engaging. The potential for improved care is exciting, yet the plethora of healthcare ideas going to market comes with risks.

Malay Gandhi, Managing Director of Rock Health, a seed fund for digital health companies, explained that “as the barriers to launching and marketing a mobile app decline towards zero, the barrier to entry has fallen dramatically — allowing unethical companies to reach consumers and potentially cause harm.”

Pure “disruptioncan be a complicated goal for companies in the digital health space, which have the potential to seriously impact a person’s life. A mission to disrupt the healthcare market must be paired with a strong commitment to evidence-based practice, rigorously evaluated outcomes and adherence to ethical and legal standards.

The potential for improved care is exciting, yet the plethora of healthcare ideas going to market comes with risks.

So, how can entrepreneurs balance innovation with sound ethics? By committing their companies to a scientific foundation. Here’s how digital health companies can advance the industry’s standards and outcomes, while guaranteeing the safety of consumers.

Apply ethical models, safeguards and scientific standards

Entrepreneurs can harness scientific methods to introduce more rigor in product development. For example, by bringing a scientist with a human-subject research background onto the leadership team to make sure the company protects and delivers on promises to consumers.

The Nuremberg Code and other subsequent rulings require “voluntary, informed consent” for research participation. This means, at a minimum, having terms of use and privacy practices that lay out clear and understandable explanations. As a best practice, companies should also explain in plain language how they use customer data and make this visible on their site.

For example, the digital health platform, PatientsLikeMe, who want patients to share their health information to create collective knowledge about disease, health and treatments, executes informed consent by asking users to agree to their privacy policy, which clearly specifies which data is shared and which is restricted.

Digital health companies have an ethical, legal and moral obligation to ensure users’ understanding of benefits and risks associated with using a product. A scientist with a valued voice in your company will be able to identify and lobby internally for these ethical standards — protecting consumers and contractors, and ensuring the company operates with an outcomes-based mission.

Create products that are for everyone, including the toughest-use cases

Digital health products designed for the majority of consumers should include protection for people who fall outside the ideal use case. By being proactive, companies catch those people who need healthcare services the most, before they fall through the cracks.

On a high level, this means that companies that impact consumers directly should always prioritize business goals in this order: safety of users, efficacy of product and, finally, driving product engagement.

To ensure safety from a tactical level, companies need to proactively develop response protocols that are tailored to appropriately handle different information received from potential or active users.

“Traditionally, our healthcare system has left consumers to discover and engage with the services they need during the moments when they have the least amount of time and support: when they’re sick and in need of help,” said Susan Dybbs, Director of Design at Collective Health. “Collective Health upends this paradigm with a people-centered design framework. By using data and real-time triggers, we deliver our members the information and tools they need, right when they need it — no matter the use case.”

For digital mental health companies, specific messages or actions could be triggered for people who rank more severe on a scale of distress than you can help, or desperately need help for a condition that your service doesn’t treat.

Maintain respect for the laws and best practices established by the medical and science communities

Yes, questioning the status quo and pushing best practices forward fuels innovation. But ignoring ethics and standards of care can put consumers and providers at risk. By encouraging licensed professionals to break ethical standards (e.g., providing treatment across state lines), companies expose contractors to repercussions.

Breakthrough, an online platform connecting patients with therapists providing online video-therapy, has closely adhered to professional ethics codes and state licensing laws. While other companies marketing online therapy have scaled quickly and sold subscriptions to anyone, regardless of location, Breakthrough has taken a more conservative approach by growing state-by-state in order to ensure availability of licensed providers before marketing services in specific states.

This is important for consumers and providers because it ensures ethical and legal provision of services. Psychologists, for example, can lose their license (and thus, their livelihood) by providing therapy across state lines.

Every major product, marketing and research decision should be a thoughtful balance between rigor and innovation.

Just like the safety procedures for users, companies should protect their contractors through very clear risk management procedures. And they should support contractors in providing exemplary service by building their solution on gold standards of care. Disruption should address an unmet need and represent a large step forward in improving quality, access and outcome.

Align your research and promises to consumers

Especially in mental health, the misrepresentation of what a product actually is or does can cause users serious distress or confusion when it doesn’t deliver the promised results for them. Digital health companies must ensure that their marketing and advertising reflect their actual research, data and expected outcome.

Lumosity, a digital health company whose scientific claims have been scrutinized by the media and neuroscience community, currently advertises that they “transform science into delightful games”. The company has one of the most in-depth and detailed sciences pages of any digital health company, and has done an excellent job clarifying how their games specifically relate to research.

Take this image from their website, which matches psychological experiments with specific Lumosity games:

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It is this kind of clear, understandable explanation that is needed to help empower individuals to be critical and informed consumers.

Ask your lead scientist to review ads and marketing material in order to flag anything that is off-base. Ensuring a consistent and clear message about your product, its value and its limitations throughout the sales funnel is critical for executing informed consent, and will help convert users who you’ll actually help.

Your data should speak for itself

“I believe that human health and happiness is sacred and that every company which markets itself as being able to improve a health outcome should have to prove it with rigor,” Gandhi stated.

Digital health companies must ensure that their marketing and advertising reflect their actual research, data and expected outcome.

Companies releasing data around their solution’s efficacy or effectiveness should follow scientific standards of data and outcome reporting, such as including a sample size and an overview of their methods so that users are empowered to make an informed decision.

Take Omada Health, for example, who “publish data through a rigorous third-party, peer-review process” and link to outcome papers about their product.

“The most significant potential problem is that someone is harmed by a digital health product,” Gandhi said. “From there, rightfully, the entire sector could be labeled as “digital snake oil,” setting many companies back years in terms of market adoption, regardless of their safety or effectiveness profile.”

To truly disrupt healthcare, digital health companies need to determine their company values, and proactively hold themselves to high ethical and outcome-driven standards. Every major product, marketing and research decision should be a thoughtful balance between rigor and innovation.

Disruption in digital health should be a balance between protecting consumers and bringing them great products they need, as quickly as possible.