App,Developer,Vision,Regulatio communication App Developer's Vision of Regulation Imposed by FDA

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Normal 0 false false false EN-US X-NONE X-NONE There are around 40,000 medical appsavailable at various app stores around the world. The apps developing industryis still an infant and experts believe that the best is yet to come. Thissignificant rise in the number of health apps has left the FDA (Food and DrugAdministration) raising its eyebrows over this issue. There is no doubt thatsmart phones and apps offer opportunities for better health monitoring andpatient's wellness. These devices and technologies have abolished the hasslesof visiting a doctor every single time with a same ailment. Few of these appshave replaced devices like glucometer and high quality microscopes in ourhospitals. Until now, apps developing industry is operatingin an unregulated manner with no one present to monitor effectiveness andaccuracy of mobile health apps. It was only last year that FDA started to lay alaw regarding this. It initiated with drafting the guidelines stating that appdevelopers engaged in developing health related apps will need to apply to FDA andseek its approval before launching their apps. Another very crucial instructionwas that all the smart devices used for health care purposes would require provingtheir safety aspect and effectiveness prior to use for any medical intention. Bothmedical world and app developers were excited about the increasing importanceof apps as an assistive tool for enhancing the quality of the medical services.Now they have received a jolt of a lifetime by these two guidelines. Time andmoney taken by FDA in reviewing and approving a device are the main concern forthe developers. There is another fraternity that believes that rules laid by theFDA are not sufficient and the government should set up a new regulatory to controlmobile app development, assessment and approval process. They suggest that appdevelopers with products such as healthy eating apps should be freed fromgetting FDA approval, as they will be developing more or less, general wellnessand fitness apps.  According to General Accountability Office,time taken by the FDA to approve a medical device that is similar to an existingproduct is around 6 months. For a brand new device, it takes around 20 months forassessment and approval. App developers feel that the procedure is too slow andhealthcare apps are increasing drastically. Therefore, there is nocompatibility in between and these two lifecycles are very different from eachother. Similarly, if we examine a report released by Stanford University, wewill notice that the cost of finding an app or a device approved by FDA is veryhigh. It ranges anywhere between USD 24 million and USD 75 million.  Despite all this, many are supporting FDA andsaying that although this process will delay the development but it isimportant for safeguarding consumers. Mr. Alain Labrique from John HopkinsUniversity claims that most apps are much hyped by their developers. He saysthat although smart devices and apps allow us to amplify quality of the servicesbut it is very important to support the claims made by developers by dataassessment and testing on stiff parameters. He further says that a developer's considerationtowards commercial and monetary gain could lead him to overstate about what hisapps are actually capable of accomplishing.  Amidst all this, it is expected that the FDAwill release its final verdict of the rules for developing health related apps laterin this year. Apps development companies have geared up to tackle it. Most ofthem have even started the initial process of apps development with the hopegiven by FDA by approving a handful of apps already.  /* Style Definitions */ table.MsoNormalTable{mso-style-name:"Table Normal";mso-tstyle-rowband-size:0;mso-tstyle-colband-size:0;mso-style-noshow:yes;mso-style-priority:99;mso-style-qformat:yes;mso-style-parent:"";mso-padding-alt:0in 5.4pt 0in 5.4pt;mso-para-margin-top:0in;mso-para-margin-right:0in;mso-para-margin-bottom:10.0pt;mso-para-margin-left:0in;line-height:115%;mso-pagination:widow-orphan;font-size:11.0pt;font-family:"Calibri","sans-serif";mso-ascii-font-family:Calibri;mso-ascii-theme-font:minor-latin;mso-fareast-font-family:"Times New Roman";mso-fareast-theme-font:minor-fareast;mso-hansi-font-family:Calibri;mso-hansi-theme-font:minor-latin;mso-bidi-font-family:"Times New Roman";mso-bidi-theme-font:minor-bidi;}