The FDA launches new guidance surrounding the development of new health-tech
The Food and Drug Administration (FDA) has recently launched several pieces of guidance to support both the development and implementation of innovative healthcare tools and technologies.
Following from the release of the FDA’s Digital Health Action Plan, FDA Commissioner Scott Gottlieb has released a statement highlighting how it will continue to support regulatory authorities on a global scale.
“We know that consumers and health care providers are increasingly embracing digital health technologies to inform everyday decisions. From fitness trackers to mobile applications tracking insulin administration, these digital tools can provide consumers with a wealth of valuable health information.
Further, clinical evidence demonstrates that consumers who are better informed about health make better and more efficient decisions, take steps to improve their lifestyles and their health choices, and often experience better outcomes.”
Adapting its policies to foster innovation, the FDA will provide increased clarity on its role to support the growth of the digital health industry and support healthcare providers and professionals in the delivery of exceptional patient care and improve decision making across the board.
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“The first draft guidance, “Clinical and Patient Decision Support Software,” outlines our approach to clinical decision support software (CDS). CDS has many uses, including helping providers, and ultimately patients, identify the most appropriate treatment plan for their disease or condition,” explains Gottlieb.
“However, the FDA will continue to enforce oversight of software programs that are intended to process or analyse medical images, signals from in vitro diagnostic devices or patterns acquired from a processor like an electrocardiogram that use analytical functionalities to make treatment recommendations, as these remain medical devices under the Cures Act.”
The second draft guidance, titled Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act, outlines the FDA’s stance of the types of software which they consider to no longer be viable medical devices. It will become a significant document for providers who could be utilising outdated technologies and processes, or for the implementation of new applications which are outside of the FDA’s domain, such as mobile technologies, which bring a multitude of benefits to its users.
Through collaborating with health authorities on a global scale through the International Medical Device Regulators Forum (IMDRF), the FDA has additionally released its final guidance, Software as a Medical Device: Clinical Evaluation, establishing the areas in which regulators will need to address in evaluating the safety, effectiveness and performance of Software as a Medical Device (SaMD) and the potential risks surrounding such technologies.
NHS care homes are better than private, report finds
A new survey has found that 60% of people with parents in NHS care homes believe the quality of care has improved, compared to just 49% of respondents with parents in private care facilities.
The survey was conducted by Kepler Vision Technologies, an AI-driven company formed at the University of Amsterdam. It was carried out among UK adults with parents over the age of 75.
Respondents cited more capable care staff and better monitoring systems as being the main reasons for improvement.
However those who do not have parents in assisted living facilities had a different viewpoint - in this case only 35% of respondents believe that NHS facilities are improving, compared to 32% who believe it is only improving in the private sector.
Only 18% of people whose parents live with them or independently believe care home staff are able to look after residents to a good standard.
Kepler Vision say this difference in opinion is due to perceived budget cuts and financial pressures, with 67% of people commenting that a lack of funding has had a negative effect on care in both NHS and private care facilities.
Other key findings of the survey include:
* Out of those who say quality has declined in care homes, 69% say the NHS is dealing with budget cuts and increased financial pressure, while 65% also said that the private system is dealing with these pressures too
* 55% said that they or their parent have money saved specifically to pay for their future care
* 35% said the idea of their parent in a care home makes them feel frightened, although 32% say it makes them feel secure
* 52% are worried about their parent catching COVID
* 47% are worried about their parent being lonely
* 46% are concerned they could fall over alone
The announcement of this research follows the UK government's decision to delay presenting its social care budget till the autumn.
Commenting on the research, Dr Harro Stokman, CEO of Kepler Vision Technologies said: “While it is good to see that people recognise the importance of staff and face-to-face interaction in elderly care, the huge gap in opinion between those with parents in care and those without shows that there are unfair negative perceptions around the residential care space.
"More can and should be done by care homes to give people the confidence that their relatives will receive the very best care - by highlighting the excellent work of staff and how well they are able to monitor resident’s needs with easy-to-use technology.”