A guideline designed and distributed by several healthcare stakeholder groups strives to secure digital health technologies and mobile health apps, the overwhelming majority of which fall outside of HIPAA regulation.
The Digital Health Assessment Framework was launched on May 2 by the American College of Physicians, the American Telemedicine Association, and the Organization for the Review of Care and Health Applications. The methodology intends to examine the use of digital health technologies while assisting healthcare leaders and patients in assessing the factors about which online health tools to employ. Covered entities must also adopt necessary administrative, physical, and technical protections to preserve the confidentiality, integrity, and availability of electronically protected health information, according to the Health Insurance Portability and Accountability Act Rules.
Healthcare data security was never more critical, with cyberattacks on healthcare businesses on the rise and hackers creating extremely complex tools and tactics to attack healthcare firms. Before HIPAA, the healthcare field lacked a universally agreed set of security standards or broad obligations for protecting patient information. At the same time, new technologies were advancing, and the healthcare industry began to rely more heavily on electronic information systems to pay claims, answer eligibility issues, give health information, and perform a variety of other administrative and clinical duties.
Furthermore, the Office for Civil Rights at the Department of Health and Human Services has enhanced HIPAA Rule enforcement, and settlements with covered businesses for HIPAA Rule violations are being reached at a faster rate than ever before.
"Digital health technologies can provide safe, effective, and interacting access to personalized health and assistance, as well as more convenient care, improve patient-staff satisfaction and achieve better clinical outcomes," said Ann Mond Johnson, ATA CEO, in a statement. "Our goal is to provide faith that the health and wellness devices reviewed in this framework meet quality, privacy, and clinical assurance criteria in the United States," she added.
Several health apps share personal information with third parties, leaving them prone to hacks. Over 86 million people in the US use a health or fitness app, which is praised for assisting patients in managing health outside of the doctor's office. HIPAA does not apply to any health app which is not advised for use by a healthcare provider.
The problem is that the evidence strongly suggests the app developers engage in some less-than-transparent methods to compromise patient privacy. Focusing on a cross-sectional assessment of the top tier apps for depression and smoking cessation in the US and Australia, a study published in JAMA in April 2019 found that the majority of health apps share data to third parties, but only a couple disclosed the practice to consumers in one‘s privacy policies.
Only 16 of the evaluated applications mentioned the additional uses for data sharing, despite the fact that the majority of the apps were forthright about the primary use of its data.
According to the aforementioned study, nearly half of the apps sent data to a third party yet didn't have a privacy policy. But in more than 80% of cases, data was shared with Google and Facebook for marketing purposes.
Another study published in the British Medical Journal in March 2019 discovered that the majority of the top 24 health education Android applications in the USA linked user data without explicitly informing users. In 2021, a study conducted by Knight Ink and Approov found that the 30 most popular mHealth apps are highly vulnerable to API hacks, which might result in the exploitation of health data. Only a few app developers were found in violation of the Federal Trade Commission's health breach rule.
The guideline from ACP, ATA, and ORCHA aims to help the healthcare industry better comprehend product safety. "There has been no clear means to establish if a product is safe to use in a field of 365,000 goods, where the great majority fall outside of existing standards, such as medical device regulations, federal laws, and government counsel," as per the announcement.
The implementation of digital health, covering condition management, clinical risk assessment, and decision assistance, is hampered by a lack of direction. The guide is a crucial step in identifying and developing digital health technologies which deliver benefits while protecting patient safety, according to ACP President Ryan D. Mire, MD. The guidelines were developed using the clinical expertise of ACP and ATA members, along with ORCHA's app assessment experience.
ACP also launched a pilot test of digital health solutions that were evaluated against the new framework in conjunction with the new framework. Mire hopes that the trial will assist providers to identify the most effective features for recommending high-value digital health technologies to patients and identify potential impediments to extensive digital health adoption.
