????10年來，無數創業者在世界各地建立了數字健康公司。目前，市面上的健康類App超過10萬個，目的都是讓我們變的更健康。然而，其中有多少家公司能拿出確鑿證據來支持自己的保健方法呢？Omada Health公司聯合創始人兼首席執行官肖恩·達菲認為這樣的公司不多。Omada Health也是一家數字健康公司，它開發的軟件針對可能患慢性病的人群。達菲說：“這樣的公司仍很罕見。”

????實際上，由于涉及數字健康產品和服務的臨床和經濟證據是如此匱乏，以至于有人專門建立了一家初創型企業來解決這個問題。這就是Evidation Health。該公司CEO黛博拉·基爾帕特里克說，他們的工作就是分析數字健康公司的宣傳廣告，因為經科學檢驗的數字保健方法少之又少。

????基爾帕特里克表示：“我不會說這些公司無法為自己宣稱的東西提供依據。它們只是還沒有[予以證明]。這些公司能否做到這一點還有待觀察。”

????她認為，數字健康行業缺乏依據的原因是在這方面幾乎沒有投入過時間和資金，也幾乎沒有相關的專業知識。她說：“公平地講，數字健康這個行業還相當年輕。”

????基爾帕特里克說，目前許多數字健康公司仍在走向成熟，它們拿到了天使投資，或者正在進行A輪或B輪融資；這個行業也仍在探索提高保健效果意味著什么。建立這些公司的創業者往往來自消費品行業，而不是醫療保健行業。因此，他們知道證據很重要，但不知道怎樣找到證據。

????臨床試驗是證明健康干預措施行之有效的標準途徑，但其費用之昂貴令人望而卻步。同時，這項工作通常需要一個資源豐富并且能接觸到病人的合作伙伴，比如醫院。但醫療保健機構往往不愿意跟沒有證據支持的小公司合作，而找不到合作伙伴的小公司又無法拿出證據。此外，作為臨床試驗場所，醫院習慣于就此收取費用；初創公司則希望醫院在試用其解決方案時付錢，這也是一個障礙。

????基爾帕特里克指出，消費型科技的市場潛力在于得到消費者使用。但在醫療保健領域，推動產品或服務得到應用的經常是步調緩慢的醫療機構、保險公司和制藥企業。她說：“這個應用過程要復雜得多，規模也大得多。”

????非營利醫療服務機構Ochsner Health System首席臨床轉化官理查德·米拉尼博士表示，醫院對數字健康技術的采用受多個因素影響。醫療保健領域需要顛覆，但必須小心地顛覆。

????米拉尼博士說：“你得對自己采用的技術可靠而且精確這件事有把握。這確實是個問題。如果能拿出一些科學數據，或者經過同行檢驗的數據來予以證明，事情當然會變得容易一些。”

????在風險投資方GE風投和醫療機構Stanford Health Care的支持下，Evidation Health把數字健康公司和醫療系統聯系在了一起。該公司基于醫療、行為和背景數據來設計并開展相關研究，以驗證數字保健方法的效果，比如對社交媒體Buzzfeed推廣的Fitbit計步器進行72小時的驗證，或者長期觀察一款按時服藥App能否改善醫院的臨床治療結果。

????基爾帕特里克說：“基于這些研究結論，我們就可以改變客戶以及合作伙伴對其業務的看法。”

????一些數字健康公司已經在有威望的行業評估刊物上公布了相關數據，以證明自身數字保健方法的效果，達菲的Omada Health就是其中較引人注目的一家。在用人單位支持下，該公司針對可能患慢性病的人群推出了一個為期16周的在線數字健康項目，作用是改變他們的行為。CEO達菲指出，這個項目于2011年設立，就是為了解決數字健康行業越來越缺乏證據的問題。他說：“我們從第一天起就在互聯網上公布數據。”Omada Health積累了一年的數據后才公布了第一個同行評審研究的結果。現在達菲表示，Omada Health是這個領域中唯一一家公布過某個數字健康項目兩年數據的公司。

????達菲指出，毫無疑問，進行以證據為基礎的研究從邏輯上看很復雜。入門級研究的成本就可能達到數十萬美元，而更深入的研究會耗資數百萬。但他認為這樣做是對的。畢竟，如果沒有證據支持，誰也不會讓病人接受新的藥物或手術。

????達菲說：“我覺得數字健康也不應例外。在我看來，數字健康行業需要朝著這個方向邁進，以便越來越多地贏得信任。”

????一些創業者已經向達菲提出請求，希望為自己的產品和服務找到證據。達菲表示，此類請求的數量表明，數字健康公司開始意識到將自身技術商業化的最佳途徑就是證明它的效用。他說：“今后四、五年，能拿出確鑿證據的公司將變得不那么少見。”（財富中文網）

????譯者：Charlie

????校對：詹妮

????Countless entrepreneurs around the world have launched digital health companies in the last decade and more than 100,000 mobile apps are currently on the market—all with the goal of making us healthier. But how many of these companies have concrete evidence to support their health claims?

????Not many, says Sean Duffy, co-founder and CEO ofOmada Health, a digital health company that develops programs for people at risk for chronic disease. “It’s still rare,” he adds.

????In fact, there’s such a lack of clinical and economic evidence on the effectiveness of digital health products and services that a new startup was created just to focus on the problem. Evidation Health works to parse the marketing claims of digital health companies, which are rarely proven using scientific evidence, says CEO Deborah Kilpatrick.

????“I wouldn’t couch it in the context of, ‘these companies are making claims they can’t back up,’” she says. “They just haven’t [proven them]. Whether or not they can remains to be seen.”

????Kilpatrick blames little time, knowledge and money spent on evidence in the digital health world for the lack of proof. “In all fairness,” she says, “digital health as a sector is still fairly young.”

????Many digital health companies are just now reaching maturity—they’re angel funded or in Series A or B rounds—and the sector is still figuring out what it means to prove effectiveness, Kilpatrick says. The entrepreneurs building these companies frequently come from the consumer sector, rather than healthcare, she says, so while they understand the importance of evidence, they don’t know how to generate it.

????Clinical trials—the standard in proving the effectiveness of health interventions—can be prohibitively expensive. And these tests usually require a partner with ample resources and access to patients, such as a hospital. Healthcare systems are often reluctant to partner with small companies that don’t have evidence, and these companies can’t get the evidence without a partner. Another hitch: hospitals are accustomed to being paid to host clinical trials, but startups want hospitals to pay them to pilot their solutions.

????Market potential in the consumer tech world is based on customer adoption, Kilpatrick says. But in healthcare, often slow-moving hospital systems, insurance payers, and pharmaceutical companies drive adoption. “It’s a much more complex and larger process of adoption,” she says.

????Several factors play a role in a hospital’s adoption of digital health technology, says Dr. Richard Milani, chief clinical transformation officer at Ochsner Health System. Healthcare needs disruption, he says, but it must be done carefully.

????“You want to be comfortable that the technology you’re utilizing is reliable and accurate,” Milani says. “That’s a genuine concern. If you have some scientific data or peer-reviewed data to back it up, that certainly makes it a little easier.”

????Evidation Health, which is backed by GE Ventures and Stanford Health Care, brings together digital health companies and healthcare systems. Evidation designs and executes outcome studies based on medical, behavioral and contextual data. The studies range from a 72-hour investigation into Fitbit claims made by Buzzfeed to a long-term look into whether a medication adherence app can improve a hospital’s clinical outcomes.

????“This allows us to redefine for clients and partners the way they think about their business on the basis of these outcomes,” Kilpatrick says.

????Duffy’s Omada Health is one notable example of a digital health company that has published its outcomes data in respected peer-reviewed journals. Omada offers an employer-sponsored 16-week online digital health program to promote behavioral change in people at risk for chronic disease. It was founded in 2011 in response to the growing lack of evidence in the digital health sector, Duffy says. “We had the intent to publish from day one,” he says. Omada’s first peer-reviewed study wasn’t released until the company had a year’s worth of data. Now, Duffy claims Omada is the only company in its space to publish two-year data from a digital program.

????There’s no doubt, Duffy says, that producing evidence-based studies is logistically complex. The cost of an entry-level study is likely to reach into the hundreds of thousands, though more robust research can tip into the millions. But, he says, it’s the right thing to do. After all, we wouldn’t subject patients to a new pharmaceutical or surgery without the evidence to back it up.

????“I don’t know why digital should be the exception,” Duffy says. “That’s the direction I think digital health needs to take to gain increasing trust.”

????Based on the number of queries he gets from entrepreneurs who want to generate evidence to back up their products and services, Duffy says digital health companies are beginning to realize that the best way to commercialize their tech is to prove it works. “In the next four or five years,” he says, “it will become less rare.”